Optimization of Generx (Ad5FGF-4) Clinical Trial Design for Refractory Angina: Interim Results of the Phase 3 ASPIRE Trial
|
|
- Lewis Stevens
- 5 years ago
- Views:
Transcription
1 Optimization of Generx (Ad5FGF-4) Clinical Trial Design for Refractory Angina: Interim Results of the Phase 3 ASPIRE Trial Gabor M Rubanyi, MD. PhD. Angionetics Inc., San Diego, CA ASGCT, New Orleans, LA May 15, 2015
2 Significant Medical Need Exists in Refractory Angina Pectoris 900,000 patients in the US have no or poor existing therapeutic options (Mukherjee et al, 1999; Losordo et al, 2013) 20% of the approximately 1 million angina patients who undergo angiographic evaluation a year have no large coronary artery disease (<70% stenosis) (Vermeltfort et al, 2010): Microvascular Angina (e.g. Cardiac Syndrome X) No-Option Patients : Need New Treatment Paradigm
3 Therapeutic Angiogenesis: The use of angiogenic growth factors (recombinant proteins or genes) to expedite and/ or augment collateral artery development in myocardial or hind-limb ischemia to improve blood flow and function. J.M. Isner et al., JCI 1994, 93:
4 Coronary Collateral Network Well-developed Collateral Network Poorly-developed Collateral Network Well-developed Coronary Collateral Network Reduces Stress-Induced Myocardial Ischemia Downstream of Large Artery Narrowing
5 Benefits of Coronary Collaterals in Heart Disease Well developed coronary collateral network (CFI>0.25) is associated with reduced: - Myocardial ischemia (Steg et al, 2010) - Infarct size (Habib et al, 1991) - CV mortality (Meier et al, 2007) - All-cause mortality (Meier et al, 2012)
6 However Only 20-30% of patients with CAD (Seiler, 2010) and 50% of patients with refractory angina (Yetkin et al, 2015) have well-developed coronary collateral network
7 Therapeutic Modalities for Stimulation of Coronary Collateral Growth Mechanical (ECP) Protein Therapy (VEGF,FGF) 2011 Cardium Therapeutics, Inc. Gene Therapy Cell Therapy
8 Gene and Cell Therapy Clinical Trials in Patients with Refractory Angina (ClinicalTrials.gov) Gene Therapy: 1. KAT301 (Phase 1, Ad5VEGF-D, i.m./noga, Finland) 2. VM202 (Phase 1/2, phgf, i.m., ViroMed, South Korea) 3. ASPIRE (Phase 3, Ad5FGF-4, i.c., Cardium, International Trial- Active) 4. AWARE (Phase 3, Ad5FGF-4, i.c., Cardium, US Trial Not Active) Cell Therapy: RENEW (Phase 3, autologous CD34+ cells, Baxter)
9 ASPIRE Study Product: Ad5FGF-4 Recombinant angiogenic gene transfer product First generation E1-deleted recombinant adenovirus (human serotype 5) Human fibroblast growth factor-4 (FGF-4) transgene driven by CMV promoter Adenovector construct carries the FGF-4 Gene for Cardiac Delivery
10 Generx [Ad5FGF-4] Clinical Studies Year Study Name Region / County Clinical Study Phase Patient Status Clinical Endpoint Number Patients Recruited 1999 AGENT-1 U.S. Phase 1/2 Dose finding & safety Class 2 3 Angina Exercise Treadmill Time AGENT-2 North America Phase 2a Mechanism of Action Study >9% Reversible Reperfusion Defect SPECT Imaging AGENT-3 North America Phase 2b/3 Class 2 4 Angina Exercise Treadmill Time AGENT-4 Western Europe & South America Phase 2b/3 Class 2 4 Angina Exercise Treadmill Time 252 TOTAL 683
11 New Insights 1. Mechanism of adaptive functional collateral network formation provided guidance for: a. biological processes to be stimulated b. target sites for product delivery 2. FGF-4 Biology 3. Ad5 Vector and Its Delivery
12 Dog/Human Single Vessel Disease Pig/Human Multi Vessel Disease van Royen et al., Cardiovasc. Res. 49: , 2001
13 What Biological Processes to Stimulate and Where? Therapeutic angiogenesis should stimulate / facilitate both angiogenesis and arteriogenesis TA product should reach both the peri-ischemic regions and also pre-existing collaterals
14 FGF Biology FGF-2 is involved in both arteriogenesis and angiogenesis during adaptive collateral growth FGF-4 has biology similar to FGF-2, but it has a signal sequence, facilitating its paracrine function FGF-2 and FGF-4 stimulate local production of other angiogenic growth factors (VEGF, HGF, PDGF, MCP- 1, NO)
15 Upregulation of Endogenous VEGF by Ad5FGF-4 in Rabbit Hindlimb Rissanen et al. FASEB J, 17: , 2000
16 FGF-4 (4 ng/ml) Stimulates the Release of VEGF from Fibroblasts (NHDF) but not from Endothelial Cells (HUVEC) in a Co-Culture System (Essen Biosciences) Rubanyi GM. J Cardiovasc Pharmacol. 64: , 2014
17 Is Ad5 an Appropriate Vector? Short-term (2-3 weeks) gene expression is ideal for clinical applications in which the goal is to build new biologic structures. (such as) the expression of angiogenic genes in the myocardium to generate new coronary vasculature. Crystal RG, Human Gene Therapy, 25:3-11, 2014
18 Optimal Route of Ad5 Delivery to the Heart Antegrade Intracoronary Artery Infusion
19 19
20 Optimizing Intracoronary Artery Delivery Method to Increase Ad5 Transduction of Cardiac Myocytes
21 Barriers to Effective Intravascular Delivery of Ad5 Vector to the Heart
22 Animal Studies: Myocardial Ischemia Enhances Ad5 Gene Transfer Author Species Ischemia Logeart (2001) Rabbit Yes Transfection / Increase Yes, >3500% Yap (2001) Rat Yes, PA occlusion Yes, >1300% Emani (2003) Piglet Yes Yes, >1000% Muhlhauser (1996) Pig No, Normal Pig No Giordano (1996) Pig Ameroid Yes, >1000% Vinten-Johanson (2010) Pig, Infarct Yes Yes, >1000%
23 Generx Historical Data: Myocardial Ischemia Is Required for Efficacy Pig ameroid model: ischemia during stress AGENT-1: Large inter-patient variability in Ad5 myocardial uptake (0-100%) AGENT-3&4: Efficacy only in patients with more severe disease (CCS Class 3&4, >55 yrs old, limited exercise capacity, women) 23
24 Transient Coronary Occlusion Pig Study 1. Control i.c. Ad5Luc 2. Double Occlusion 3 Occlusion 5 i.c. Ad5Luc 3 Occlusion 3. Double Occlusion + NTG 3 Occlusion 5 i.c. Ad5Luc 3 Occlusion i.c. NTG
25 Effect of Two 3-min Coronary Artery Balloon Occlusions (+/- NTG) on Luciferase Expression in Pig Heart (Intracoronary 10e 11 vp Ad5Luc) (n=5) 100 * p<0.05 vs. N.O. * Pg Luc / g tissue No Occlusion Double Occlusion Double Occlusion + NTG Shi et al, Human Gene Therapy 23: , 2012
26 The ASPIRE Trial A randomized, controlled, parallel group, multicenter phase 3 study to evaluate the efficacy and safety of Ad5FGF-4 using SPECT myocardial perfusion imaging in patients with stable angina pectoris (Similar to AGENT-2)
27 Changes in Protocol vs AGENT-2 Trial Ad5FGF-4 dose 3x higher (3x10e10 vp; 30x lower than MTD) Modified intracoronary product delivery (similar to that used in pig study) Control group: ongoing standard medication, but no placebo infusion
28 Patient Population Patients with refractory angina pectoris who are not candidates for coronary interventions and have Reversible Perfusion Defect Size (RPDS) of 9% by SPECT imaging (Poor Collateral Development) Total enrollment: 100 patients (1:1 randomization to Group A (Generx) and Group B (Control))
29 Primary Clinical Efficacy Endpoint: Change in Collateral-Dependent Myocardial Perfusion Well-developed Collateral Network Poorly-developed Collateral Network Therapeutic Goal: Improve Collateral-Dependent Flow to Reduce Stress-Induced Ischemia (Angina) in Patients with Poorly Developed Collateral Network (RPDS>9%)
30 AGENT-2 SPECT Clinical Efficacy Endpoint Improvement in Reversible Perfusion Defect Size as Measured by SPECT Imaging Baseline Pre-Generx Treatment 4 Weeks Following Generx Administration 8 Weeks- 77% Improvement in Perfusion (RPDS) Grines et al., JACC 42: (2003)
31 Secondary Clinical Efficacy Endpoints Angina diary Nitroglycerin use Seattle Angina Questionnaire Clinical assessment of CCS angina class
32 Clinical Endpoints: Safety Day 0: complications of product administration Week 1, 4 and 8: adverse events clinical laboratory evaluations Long-term follow-up (12 month)
33 ASPIRE: Generx Infusion Protocol i.c. Ad5FGF Occlusion 3 Occlusion i.c. NTG (200ug)
34 ASPIRE Clinical Study Design 9% Reversible Perfusion Defect Size (RPDS) Baseline SPECT Imaging Initial pilot study confirm new delivery method is safe and effective N=10-12 Main Study N = 90 Group A One time Generx Infusion N = 45 Group B Standard of Care N = 45
35 Pre-Specified Interim Analysis 11 patients completed 8 week protocol: Active (n=7) Control (n=4)
36 ASPIRE Interim Analysis: Safety No untoward clinical or laboratory findings New product delivery procedure well tolerated
37 ASPIRE Interim Analysis: Efficacy Primary Endpoint % Improvement in SPECT Reversible Perfusion Defect Size 30.00% 20.00% 10.00% 0.00% % % % % % % +24.4% P<0.05 Generx N=7-51% Control N=4
38 Summary ASPIRE trial design was optimized based on mechanistic insights and new experimental studies Pre-specified interim analysis confirmed safety of new delivery method and provided encouraging efficacy results Next steps: Completion of ASPIRE trial in Russia and restart of AWARE trial in the US
Zachary I. Hodes, M.D., Ph.D., F.A.C.C.
Zachary I. Hodes, M.D., Ph.D., F.A.C.C. Disclamer: I personally have no financial relationship with any company mentioned today. The Care Group, LLC does have a contract with Cardium to participate in
More informationProfessor Harvey White. Interventional Cardiologist Auckland
Professor Harvey White Interventional Cardiologist Auckland Stem cells and the heart Harvey White Director of Coronary Care Unit and Cardiovascular Research Unit Green Lane Cardiovascular Service Auckland
More informationDuring a lifetime, the human heart will beat 2.5 billion times and pump 50 million gallons of blood.
CARDIUMTHERAPEUTICS During a lifetime, the human heart will beat 2.5 billion times and pump 50 million gallons of blood. Cardium is a medical technology company focusing on innovative products for treating
More informationConflict of Interest Slide
Comparison of six- month clinical outcomes, event free survival rates of patients undergoing enhanced external counterpulsation (EECP) for coronary artery disease in the United States and Europe Ozlem
More informationPerioperative Management After Coronary Stenting: Risk Assessment Before Surgery. Christian Seiler No conflict of interest to declare.
Perioperative Management After Coronary Stenting: Risk Assessment Before Surgery Christian Seiler No conflict of interest to declare PCI Long-Term Outcome Perioperative Management After Coronary Stenting:
More informationDevices are So Old School: The New World of Myocardial Regeneration
Devices are So Old School: The New World of Myocardial Regeneration Todd K. Rosengart, M.D. Professor and Chairman DeBakey-Bard Chair of Surgery Michael E. DeBakey Department of Surgery Professor, Texas
More informationDiabetes and Occult Coronary Artery Disease
Diabetes and Occult Coronary Artery Disease Mun K. Hong, MD, FACC, FSCAI Director, Cardiac Catheterization Laboratory & Interventional Cardiology St. Luke s-roosevelt Hospital Center New York, New York
More informationHeart disease remains the leading cause of morbidity and mortality in industrialized nations. It accounts for nearly 40% of all deaths in the United
Heart disease remains the leading cause of morbidity and mortality in industrialized nations. It accounts for nearly 40% of all deaths in the United States, totaling about 750,000 individuals annually
More informationStem Cells. Keith Channon. Department of Cardiovascular Medicine University of Oxford John Radcliffe Hospital, Oxford
Stem Cells Keith Channon Department of Cardiovascular Medicine University of Oxford John Radcliffe Hospital, Oxford Adult Stem Cells Unique cells that are capable of self-renewal Have the ability to differentiate
More informationHow to approach non-infarct related artery disease in patients with STEMI in a limited resource setting
How to approach non-infarct related artery disease in patients with STEMI in a limited resource setting Ahmed A A Suliman, MBBS, FACP, FESC Associate Professor, University of Khartoum Interventional Cardiologist,
More informationEffect of Intravascular Ultrasound- Guided vs. Angiography-Guided Everolimus-Eluting Stent Implantation: the IVUS-XPL Randomized Clinical Trial
Effect of Intravascular Ultrasound- Guided vs. Angiography-Guided Everolimus-Eluting Stent Implantation: the IVUS-XPL Randomized Clinical Trial Myeong-Ki Hong, MD. PhD on behalf of the IVUS-XPL trial investigators
More informationPearls & Pitfalls in nuclear cardiology
Pearls & Pitfalls in nuclear cardiology Maythinee Chantadisai, MD., NM physician Division of Nuclear Medicine, Department of radiology, KCMH Principle of myocardial perfusion imaging (MPI) Radiotracer
More informationMicrovascular Disease: How to Diagnose and What s its Treatment
Microvascular Disease: How to Diagnose and What s its Treatment Laxmi S. Mehta, MD, FACC The Ohio State University Medical Center Assistant Professor of Clinical Internal Medicine Clinical Director of
More informationPerspective in Progress of Cardiovascular Gene Therapy
J Pharmacol Sci 95, 1 8 (2004) Journal of Pharmacological Sciences 2004 The Japanese Pharmacological Society Current Perspective Perspective in Progress of Cardiovascular Gene Therapy Ryuichi Morishita
More informationNEW INTERVENTIONAL TECHNOLOGIES
by Lawrence M Prescott, PhD NEW INTERVENTIONAL TECHNOLOGIES EXPAND TREATMENT OPTIONS FOR CARDIOVASCULAR DISEASE Novel interventional techniques are proving to be of particular value in the treatment of
More informationManagement of stable CAD FFR guided therapy: the new gold standard
Management of stable CAD FFR guided therapy: the new gold standard Suleiman Kharabsheh, MD Director; CCU, Telemetry and CHU Associate professor of Cardiology, Alfaisal Univ. KFHI - KFSHRC Should patients
More informationSafety and Efficacy of the Coronary Sinus Reducer in Patients with Refractory Angina: the COSIRA Trial
Safety and Efficacy of the Coronary Sinus Reducer in Patients with Refractory Angina: the COSIRA Trial (COronary SInus Reducer for Treatment of Refractory Angina) Stefan Verheye, MD Cardiovascular Center,
More informationImaging ischemic heart disease: role of SPECT and PET. Focus on Patients with Known CAD
Imaging ischemic heart disease: role of SPECT and PET. Focus on Patients with Known CAD Hein J. Verberne Academic Medical Center, University of Amsterdam, Amsterdam, Netherlands International Conference
More informationIschemia and Reperfusion: Pharmacological treatment options
Physiologisches Institut Ischemia and Reperfusion: Pharmacological treatment options Prof. Dr. Rainer Schulz Plaque rupture and myocardial ischemia Acute plaque rupture (Stary VI) Ischemic myocardium (ACS,
More informationA new treatment option to conventional
246 REVIEW Recent insights into human coronary collateral development M Fujita, K Tambara... Enhancement of coronary collateral function is an intriguing approach to the preservation of ischaemic myocardium.
More informationPROMUS Element Experience In AMC
Promus Element Luncheon Symposium: PROMUS Element Experience In AMC Jung-Min Ahn, MD. University of Ulsan College of Medicine, Heart Institute, Asan Medical Center, Seoul, Korea PROMUS Element Clinical
More informationMultigene Therapy by Ultrasound-mediated Plasmid Delivery:
Multigene Therapy by Ultrasound-mediated Plasmid Delivery: Temporally separated delivery of vascular endothelial growth factor and angiopoietin-1 promotes sustained angiogenesis in chronically ischemic
More informationEndothelial PGC 1 - α 1 mediates vascular dysfunction in diabetes
Endothelial PGC-1α mediates vascular dysfunction in diabetes Reporter: Yaqi Zhou Date: 04/14/2014 Outline I. Introduction II. Research route & Results III. Summary Diabetes the Epidemic of the 21st Century
More informationDisclosures. Speaker s bureau: Research grant: Advisory Board: Servier International, Bayer, Merck Serono, Novartis, Boehringer Ingelheim, Lupin
Disclosures Speaker s bureau: Research grant: Advisory Board: Servier International, Bayer, Merck Serono, Novartis, Boehringer Ingelheim, Lupin Servier International, Boehringer Ingelheim Servier International,
More informationMaria Angela S. Cruz-Anacleto, MD
Maria Angela S. Cruz-Anacleto, MD 57/Female Menopausal Non-HTN, non-dm Hypothyroid (s/p RAI 1997) Levothyroxine 100 ug OD 5 Months PTA Chest discomfort Stress Echocardiography 5 Months PTA Chest discomfort
More informationPhysiologically Assessed Coronary Collateral Flow and Adverse Cardiac Ischemic Events: A Follow-Up Study in 403 Patients With Coronary Artery Disease
Journal of the American College of Cardiology Vol. 40, No. 9, 2002 2002 by the American College of Cardiology Foundation ISSN 0735-1097/02/$22.00 Published by Elsevier Science Inc. PII S0735-1097(02)02378-1
More informationFractional Flow Reserve and instantaneous wave -free Ratio. Λάμπρος Κ. Μόσιαλος Επεμβατικός Καρδιολόγος ΓΝ Παπαγεωργίου
Fractional Flow Reserve and instantaneous wave -free Ratio Λάμπρος Κ. Μόσιαλος Επεμβατικός Καρδιολόγος ΓΝ Παπαγεωργίου DISCLOSURES There are no financial conflicts of interest relevant to this presentation
More informationEmergency surgery in acute coronary syndrome
Emergency surgery in acute coronary syndrome Teerawoot Jantarawan Division of Cardiothoracic Surgery, Department of Surgery, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand
More informationDebate Should we use FFR? I will say NO.
Debate Should we use FFR? I will say NO. Hyeon-Cheol Gwon Cardiac and Vascular Center Samsung Medical Center Sungkyunkwan University School of Medicine Dr. Hyeon-Cheol Gwon Research fund from Abbott Korea
More informationResults of an International Postmarketing Surveillance Study of pl-vegf165 Safety and Efficacy in 210 Patients with Peripheral Arterial Disease
Am J Cardiovasc Drugs (2017) 17:235 242 DOI 10.1007/s40256-016-0210-3 ORIGINAL RESEARCH ARTICLE Results of an International Postmarketing Surveillance Study of pl-vegf165 Safety and Efficacy in 210 Patients
More informationFFR Incorporating & Expanding it s use in Clinical Practice
FFR Incorporating & Expanding it s use in Clinical Practice Suleiman Kharabsheh, MD Consultant Invasive Cardiology Assistant professor, Alfaisal Univ. KFHI - KFSHRC Concept of FFR Maximum flow down a vessel
More informationTCT mdbuyline.com Clinical Trial Results Summary
TCT 2012 Clinical Trial Results Summary FAME2 Trial: FFR (fractional flow reserve) guided PCI in all target lesions Patients with significant ischemia, randomized 1:1 Control arm: not hemodynamically significant
More informationGene Therapy: Advantages Over Conservative/Standard T h e r a p y
IAGS Proceedings VA S C U L A R G E N E T H E R A P Y Preclinical and Clinical Experience in Va s c u l a r Gene Therapy: Advantages Over Conservative/Standard T h e r a p y Sigrid Nikol, MD and * Tanya
More informationIschemic Postconditioning During Primary Percutaneous Coronary Intervention Mechanisms and Clinical Application Jian Liu, MD FACC FESC FSCAI Chief Phy
Ischemic Postconditioning During Primary Percutaneous Coronary Intervention Mechanisms and Clinical Application Jian Liu, MD FACC FESC FSCAI Chief Physician, Professor of Medicine Department of Cardiology,
More informationPerioperative Cardiology Consultations for Noncardiac Surgery Ischemic Heart Disease
2012 대한춘계심장학회 Perioperative Cardiology Consultations for Noncardiac Surgery Ischemic Heart Disease 울산의대울산대학병원심장내과이상곤 ECG CLASS IIb 1. Preoperative resting 12-lead ECG may be reasonable in patients with
More informationFollow-up of the CUPID Gene Therapy Trials
Follow-up of the CUPID Gene Therapy Trials Roger J. Hajjar, MD Icahn School of Medicine at Mount Sinai New York, NY Pathway to Heart Failure Injury / Damage Mature Dysfunctional Dying New Coronary Disease
More informationFractional Flow Reserve: Review of the latest data
Fractional Flow Reserve: Review of the latest data Michalis Hamilos, MD, PhD, FESC University Hospital of Heraklion Fractional Flow Reserve (FFR) Coronary angiography does not always tell the truth Most
More informationFractional Flow Reserve: Basics, FAME 1, FAME 2. William F. Fearon, MD Associate Professor Stanford University Medical Center
Fractional Flow Reserve: Basics, FAME 1, FAME 2 William F. Fearon, MD Associate Professor Stanford University Medical Center Conflict of Interest Advisory Board for HeartFlow Research grant from St. Jude
More informationMechanisms and role of contrast echocardiography
Mechanisms and role of contrast echocardiography Seol Sang-Hoon Inje University College of Medicine, Haeundae Paik Hospital, Busan, Korea Physical Principles of Contrast Ultrasound Contrast echocardiography
More informationClopidogrel Date: 15 July 2008
These results are supplied for informational purposes only. Prescribing decisions should be made based on the approved package insert in the country of prescription Sponsor/company: sanofi-aventis ClinicalTrials.gov
More informationTherapeutic Angiogenesis: The Pros and Cons and the Future
REVIEW Korean Circ J 2008;38:73-79 Print ISSN 1738-5520 / On-line ISSN 1738-5555 Copyright c 2008 The Korean Society of Cardiology Therapeutic Angiogenesis: The Pros and Cons and the Future Jae Kean Ryu,
More informationSHOCKWAVE THERAPY FOR REFRACTORY ANGINA PECTORIS
SHOCKWAVE THERAPY FOR REFRACTORY ANGINA PECTORIS S. Marra MD FESC G. Alunni MD Cardiology 2 Torino University S. Giovanni Battista Hospital Italy Ischemic area by SPECT O.C.83, Female Hypertension Previous
More informationWomen s Ischemia and cardiac rehabilitation
Women s Ischemia and cardiac rehabilitation Dr. Pallavi Bellamkonda MD, FACC Financial Disclosures: None 1 Objectives Understanding the Unique presentations of Ischemic Disease in Women: Obstructive Coronary
More informationSung A Chang Department of Internal Medicine, Division of Cardiology, Sungkyunkwan University School of Medicine, Samsung Medical Center
CMR Perfusion and Viability A STICH Out of Time? Sung A Chang Department of Internal Medicine, Division of Cardiology, Sungkyunkwan University School of Medicine, Samsung Medical Center Can Imaging Improve
More informationOptimal testing for coronary artery disease in symptomatic and asymptomatic patients
Optimal testing for coronary artery disease in symptomatic and asymptomatic patients Alexandre C Ferreira, MD Clinical Chief of Cardiology Jackson Health System Director, Interventional Cardiology Training
More informationSlide 1. Slide 2 Conflict of Interest Disclosure. Slide 3 Stroke Facts. The Treatment of Intracranial Stenosis. Disclosure
Slide 1 The Treatment of Intracranial Stenosis Helmi Lutsep, MD Vice Chair and Dixon Term Professor, Department of Neurology, Oregon Health & Science University Chief of Neurology, VA Portland Health Care
More informationAutologous CD34 + Cells for Treatment of Refractory Angina: Meta-Analysis of 3 Randomized, Double-Blinded Studies
Autologous CD34 + Cells for Treatment of Refractory Angina: Meta-Analysis of 3 Randomized, Double-Blinded Studies Thomas J. Povsic, MD, PhD Associate Professor of Medicine Duke Clinical Research Institute,
More informationT he coronary collateral circulation is an alternative source
1289 CARDIOVASCULAR MEDICINE Influence of diabetes mellitus on coronary collateral flow: an answer to an old controversy R Zbinden, S Zbinden, M Billinger, S Windecker, B Meier, C Seiler... See end of
More informationAtypical pain and normal exercise test
Atypical pain and normal exercise test F. Mut, M. Beretta Nuclear Medicine Service, Asociacion Española Montevideo, Uruguay Clinical history 67-year old male with several coronary risk factors. Atypical
More informationFRACTIONAL FLOW RESERVE USE IN THE CATH LAB BECAUSE ANGIOGRAPHY ALONE IS NOT ENOUGH!!!!!!!!
FRACTIONAL FLOW RESERVE USE IN THE CATH LAB BECAUSE ANGIOGRAPHY ALONE IS NOT ENOUGH!!!!!!!! Juan Antonio Pastor-Cervantes,M.D FSCAI, FACC Cardiovascular Institute Memorial Regional Hospital Hollywood Florida
More informationCHRONIC HEART FAILURE : WHAT ELSE COULD WE OFFER TO OUR PATIENTS? Cardiac Rehabilitation Society of Thailand
CHRONIC HEART FAILURE : WHAT ELSE COULD WE OFFER TO OUR PATIENTS? Cardiac Rehabilitation Society of Thailand ENHANCED EXTERNAL COUNTER PULSATION Piyanuj Ruckpanich, MD. Cardiac Rehabilitation Center Perfect
More informationCindy L. Grines MD FACC FSCAI
Cindy L. Grines MD FACC FSCAI Hofstra Northwell School of Medicine Chair, Cardiology Academic Chief of Cardiology, Northwell Health North Shore University Hospital, Manhasset NY Multivessel Disease in
More informationHow to Evaluate Microvascular Function and Angina. Myeong-Ho Yoon Ajou University Hospital
How to Evaluate Microvascular Function and Angina Myeong-Ho Yoon Ajou University Hospital Angina without Coronary Artery Disease (CAD) Prevalence: 20-30% going c-angiography, with a higher prevalence (almost
More informationNovel Markers of Arterial Dysfunction
혈관연구회창립심포지움, 3 월 3 일, 2005 Novel Markers of Arterial Dysfunction Kwang Kon Koh, MD, FACC, FAHA Cardiology Gachon Medical School Incheon, Korea Atherosclerosis: A progressive process PHASE I: Initiation
More informationWomen and Coronary Artery Disease:
Women and Coronary Artery Disease: Less is More? Interventional Cardiology 2017 32 th Annual International Symposium Snow Mass March 5-10 Yolande Appelman MD, PhD,FESC EAPCI-Women Interventional Cardiologist
More informationCASE from South Korea
CASE from South Korea Bon-Kwon Koo, MD, PhD, Seoul, Korea Outpatient clinic of a non-interventional cardiologist F/56 Chief complaint: Angina with recent aggravation, CCS II~III Brief history: # Stroke
More informationProgenitor Cell Therapy for the Treatment of Damaged Myocardium due to Ischemia. Original Policy Date
MP 2.02.14 Progenitor Cell Therapy for the Treatment of Damaged Myocardium due to Ischemia Medical Policy Section Medicine Issue 12:2013 Original Policy Date 12:2013 Last Review Status/Date Reviewed with
More informationNew Insight about FFR and IVUS MLA
New Insight about FFR and IVUS MLA Can IVUS MLA Predict FFR
More informationEvaluating Clinical Risk and Guiding management with SPECT Imaging
Evaluating Clinical Risk and Guiding management with SPECT Imaging Raffaele Giubbini Chair and Nuclear Medicine Unit University & Spedali Civili Brescia- Italy U.S. Congressional Budget Office. Technological
More informationCellular and molecular players in vascular and left ventricular remodeling Hakimzadeh, N.
UvA-DARE (Digital Academic Repository) Cellular and molecular players in vascular and left ventricular remodeling Hakimzadeh, N. Link to publication Citation for published version (APA): Hakimzadeh, N.
More informationFractional Flow Reserve and the Results of the FAME Study
Imaging and Physiology Summit Seoul, Korea November 21 st, 2009 Fractional Flow Reserve and the Results of the FAME Study William F. Fearon, M.D. Assistant Professor Division of Cardiovascular Medicine
More informationFFR vs. icecg in Coronary Bifurcations (FIESTA) - preliminary results. Dobrin Vassilev MD, PhD National Heart Hospital Sofia, Bulgaria
FFR vs. icecg in Coronary Bifurcations (FIESTA) - preliminary results Dobrin Vassilev MD, PhD National Heart Hospital Sofia, Bulgaria I would like to express my personal gratitude to Dr. BK Koo for opening
More informationTechnical Aspects and Clinical Indications of FFR
Technical Aspects and Clinical Indications of FFR Emanuele Barbato, MD, PhD, FESC Cardiovascular Center Aalst - OLV Clinic Aalst, Belgium Potential conflicts of interest Consulting fees and honoraria on
More informationFractional Flow Reserve (FFR) --Practical Set Up Pressure Measurement --
Fractional Flow Reserve (FFR) --Practical Set Up Pressure Measurement -- JoonHyung Doh, MD, PhD Assistant Professor, Vision21 Cardiac and Vascular Center Inje University Ilsan Paik Hospital Goyang, Korea
More informationSolving the Dilemma of Ostial Stenting: A Case Series Illustrating the Flash Ostial System
Volume 1, Issue 1 Case Report Solving the Dilemma of Ostial Stenting: A Case Series Illustrating the Flash Ostial System Robert F. Riley * and Bill Lombardi University of Washington Medical Center, Division
More informationMesenchymal Stem Cells to Repair Vascular Damage after Chemotherapy: Past, Present and Future
Mesenchymal Stem Cells to Repair Vascular Damage after Chemotherapy: Past, Present and Future Cell Therapy 2014 Las Vegas, NV, USA Sulaiman Al-Hashmi, PhD Sultan Qaboos University Oman What are MSCs? Stem
More informationTherapeutic arteriogenesis: from experimental observations towards clinical application [cum laude] van Royen, N.
UvA-DARE (Digital Academic Repository) Therapeutic arteriogenesis: from experimental observations towards clinical application [cum laude] van Royen, N. Link to publication Citation for published version
More informationframework for flow Objectives Acute Stroke Treatment Collaterals in Acute Ischemic Stroke framework & basis for flow
Acute Stroke Treatment Collaterals in Acute Ischemic Stroke Objectives role of collaterals in acute ischemic stroke collateral therapeutic strategies David S Liebeskind, MD Professor of Neurology & Director
More informationAntiplatelet Therapy in Primary CVD Prevention and Stable Coronary Artery Disease. Καρακώστας Γεώργιος Διευθυντής Καρδιολογικής Κλινικής, Γ.Ν.
Antiplatelet Therapy in Primary CVD Prevention and Stable Coronary Artery Disease Καρακώστας Γεώργιος Διευθυντής Καρδιολογικής Κλινικής, Γ.Ν.Κιλκίς Primary CVD Prevention A co-ordinated set of actions,
More informationCLINICAL CONSEQUENCES OF THE
CLINICAL CONSEQUENCES OF THE FAME STUDY TCT ASIA Seoul, Korea, april 26 th, 2012 Nico H. J. Pijls, MD, PhD Catharina Hospital, Eindhoven, The Netherlands GUIDELINES ESC SEPTEMBER 2010 FFR UPGRADED TO LEVEL
More informationFFR in unstable angina and after MI F
FFR in unstable angina and after MI F June-Hong Kim, MD. PhD Cardiovascular center Pusan National University Yangsan Hospital FFR tells you physiologic stenosis severity rather than anatomical stenosis
More informationCan Angiographic Complete Revascularization Improve Outcomes for Patients with Decreased LV Function? NO!
Can Angiographic Complete Revascularization Improve Outcomes for Patients with Decreased LV Function? NO! Young-Hak Kim, MD, PhD Heart Institute, University of Ulsan College of Medicine Asan Medical Center,
More informationHybrid cardiac imaging Advantages, limitations, clinical scenarios and perspectives for the future
Hybrid cardiac imaging Advantages, limitations, clinical scenarios and perspectives for the future Prof. Juhani Knuuti, MD, FESC Turku, Finland Disclosure: Juhani Knuuti, M.D. Juhani Knuuti, M.D. has financial
More informationTreatment of chronically myocardial ischemia by adenovirus-mediated hepatocyte growth factor gene transfer in minipigs
Science in China Series C: Life Sciences 2008 SCIENCE IN CHINA PRESS Springer www.scichina.com life.scichina.com www.springerlink.com Treatment of chronically myocardial ischemia by adenovirus-mediated
More informationCardiovascular gene therapy: current status and therapeutic potential
British Journal of Pharmacology (2007) 152, 175 188 & 2007 Nature Publishing Group All rights reserved 0007 1188/07 $30.00 www.brjpharmacol.org REVIEW Cardiovascular gene therapy: current status and therapeutic
More informationUnprotected LM intervention
Unprotected LM intervention Guideline for COMBAT Seung-Jung Park, MD, PhD Professor of Internal Medicine, Seoul, Korea Current Recommendation for unprotected LMCA Stenosis Class IIb C in ESC guideline
More informationFFR in Multivessel Disease
FFR in Multivessel Disease April, 26 2013 Coronary Physiology in the Catheterization Laboratory Location: European Heart House, Nice, France Pim A.L. Tonino, MD, PhD Hartcentrum, Eindhoven, the Netherlands
More informationLink between effectiveness and cost data Costing was conducted prospectively on the same patient sample as that used in the effectiveness analysis.
Heparin after percutaneous intervention (HAPI): a prospective multicenter randomized trial of three heparin regimens after successful coronary intervention Rabah M, Mason D, Muller D W, Hundley R, Kugelmass
More informationMyocardial Contrast Echo
Myocardial Contrast Echo Anthony DeMaria Myocardial Contrast Echocardiography: Problems and Potential Anthony DeMaria MD Judith and Jack White Chair Founding Director, Sulpizio Cardiovascular Center University
More informationDo not reopen the vessel, look at ischemia! Salvatore Colangelo
Do not reopen the vessel, look at ischemia! Salvatore Colangelo Interventistica Cardiovascolare ASL Città di Torino Ospedale San Giovanni Bosco CTO PCI: To do or not to do it? CTO PCI: To do or not to
More informationCardiac evaluation for the noncardiac. Nathaen Weitzel MD University of Colorado Denver Dept of Anesthesiology
Cardiac evaluation for the noncardiac patient Nathaen Weitzel MD University of Colorado Denver Dept of Anesthesiology Objectives! Review ACC / AHA guidelines as updated for 2009! Discuss new recommendations
More informationBIOAUTOMATION, 2009, 13 (4), 89-96
Preliminary Results оf Assessment of Systolic and Diastolic Function in Patients with Cardiac Syndrome X Using SPECT CT Tsonev Sv. 1, Donova T. 1, Garcheva M. 1, Matveev M. 2 1 Medical University Sofia
More informationJournal of the American College of Cardiology Vol. 35, No. 5, by the American College of Cardiology ISSN /00/$20.
Journal of the American College of Cardiology Vol. 35, No. 5, 2000 2000 by the American College of Cardiology ISSN 0735-1097/00/$20.00 Published by Elsevier Science Inc. PII S0735-1097(00)00546-5 CLINICAL
More informationFinancial Disclosures. Bone Marrow Mononuclear Cells. Cell Based Therapies: What Do They Do and Will They Work in CLI?
Cell Based Therapies: What Do They Do and Will They Work in CLI? None Financial Disclosures Michael P. Murphy, MD The Vascular and Cardiac Adult Stem Cell Therapy Center Indiana University School of Medicine
More informationApproach to Multi Vessel disease with STEMI
Approach to Multi Vessel disease with STEMI MANAGEMENT OF ST-ELEVATION MYOCARDIAL INFARCTION Dr. Thomas Alexander, M.D; D.M; F.A.C.C. Senior Consultant and Interventional Cardiologist Kovai Medical Centre
More informationCoronary Revascularization in Patients witj Severe LV Dysfunction.: Is the concept of viability still viable?
Coronary Revascularization in Patients witj Severe LV Dysfunction.: Implications of the STICH trial Is the concept of viability still viable? Banff 2016 3041435-1 Prognosis of Patients With LV Dysfunction
More informationContinuing Medical Education Post-Test
Continuing Medical Education Post-Test Based on the information presented in this monograph, please choose one correct response for each of the following questions or statements. Record your answers on
More informationMECHANISMS OF MYOCARDIAL ISCHEMIA
Página 1 de 9 MECHANISMS OF MYOCARDIAL ISCHEMIA Part of "46 - Coronary Blood Flow and Myocardial Ischemia" Myocardial ischemia develops when coronary blood flow becomes inadequate to meet the requirements
More informationRanolazine: An Update
Ranolazine: An Update J. Dawn Abbott, M.D., F.A.C.C., F.S.C.A.I. Director, Interventional Cardiology Fellowship Associate Professor of Medicine Brown Medical School Cardiovascular Institute Outline Ranolazine
More informationCounty of Santa Clara Emergency Medical Services System
County of Santa Clara Emergency Medical Services System Reference # 803 STEMI Data Dictionary STEMI DATA DICTIORY Effective: October 28, 2013 Replaces: January 2009 Review: October 2016 Resources: Policy
More informationCHRONIC CAD DIAGNOSIS
CHRONIC CAD DIAGNOSIS Chest Pain Evaluation 1. Approach to diagnosis of CAD 2. Classification of chest pain 3. Pre-test likelihood CAD 4. Algorithm for chest pain evaluation in women 5. Indications for
More informationCoronary Artery Disease: Revascularization (Teacher s Guide)
Stephanie Chan, M.D. Updated 3/15/13 2008-2013, SCVMC (40 minutes) I. Objectives Coronary Artery Disease: Revascularization (Teacher s Guide) To review the evidence on whether percutaneous coronary intervention
More informationResults of Clinical Trials
Results of Clinical Trials 21 patients (14 Class* IV, 6 Class III, 1 Class II) ECP given 1 hour daily, for 5 days 18 of 21 had significant diastolic augmentation (75.3 ± 1.8 vs. 123.3 ± 2.7 mmhg) 17 of
More informationDetermination of the Cardiovascular Phenotype of Different Transgenic Mouse Models
Determination of the Cardiovascular Phenotype of Different Transgenic Mouse Models Inaugural-Dissertation zur Erlangung des Grades eines Doktors der Humanbiologie des Fachbereichs Humanmedizin der Justus-Liebig-Universität
More informationAbnormal, Autoquant Adenosine Myocardial Perfusion Heart Imaging. ID: GOLD Date: Age: 46 Sex: M John Doe Phone (310)
Background: Reason: preoperative assessment of CAD, Shortness of Breath Symptom: atypical chest pain Risk factors: hypertension Under influence: a beta blocker Medications: digoxin Height: 66 in. Weight:
More informationWhen Aspiration Thrombectomy Does Not Work? A A R O N W O N G N A T I O N A L H E A R T C E N T R E S I N G A P O R E
When Aspiration Thrombectomy Does Not Work? A A R O N W O N G N A T I O N A L H E A R T C E N T R E S I N G A P O R E Thrombus in STEMI Over 70% of STEMI patients has angiographic evidence of thrombus
More informationQualitative and Quantitative Assessment of Perfusion
APCDE 2011 Qualitative and Quantitative Assessment of Perfusion Hyun Ju Yoon Chonnam National University Hospital Gwangju, Korea ISCHEMIC CASCADE Blood flow mismatch Perfusion defects on nuclear imaging,
More informationStable Angina: Indication for revascularization and best medical therapy
Stable Angina: Indication for revascularization and best medical therapy Cardiology Basics and Updated Guideline 2018 Chang-Hwan Yoon, MD/PhD Cardiovascular Center, Department of Internal Medicine Bundang
More informationNo-reflow Phenomenon in Patients with Acute Myocardial Infarction: Its Pathophysiology and Clinical Implications
No-reflow Phenomenon in Patients with Acute Myocardial Infarction: Its Pathophysiology and Clinical Implications * 164 Ito Acta Med. Okayama Vol. 63, No. 4 Normal case Anterior MI Fig. 3 Myocardial contrast
More information