Clinical Trial Details (PDF Generation Date :- Wed, 17 Apr 2019 02:24:33 GMT) CTRI Number Last Modified On 23/06/2015 Post Graduate Thesis Type of Trial Type of Study Study Design Public Title of Study Scientific Title of Study CTRI/2011/08/001939 [Registered on: 03/08/2011] - Trial Registered Prospectively No Interventional Medical Device Randomized, Parallel Group Trial Angelmed study on the device for alerting the onset of myocardial infarction/heart attack ALERTS (AngeLmed for Early Recognition and Treatment of STEMI) Study Secondary IDs if Any Secondary ID Identifier Details of Principal Investigator or overall Trial Coordinator (multi-center study) 0201-0601-008 Protocol Number NCT00781118 Designation Affiliation ClinicalTrials.gov Details of Principal Investigator Details Contact Person (Scientific Query) Details Contact Person (Public Query) Phone Fax Email Designation Affiliation Details Contact Person (Scientific Query) Dr Tarun Arora Medical Monitor Max Neeman International Phone 011-40772100 Fax 011-41001945 Email Designation Affiliation Dr.Tarun Arora Medical Monitor Max Neeman International Ltd. MaX House, 1st Floor 1, Dr Jha Marg, Okhla - III New Delhi - 110 020 110 020 tarora@neemanasia.com Details Contact Person (Public Query) Dr Shariq Anwar Director Operations Max Neeman International Phone 011-40772100 Fax 011-40548168 Max Neeman International Ltd. MaX House, 1st Floor 1, Dr Jha Marg, Okhla - III New Delhi - 110 020 110 020 page 1 / 6
Source of Monetary or Material Support Primary Sponsor Details of Secondary Sponsor Countries of Recruitment Sites of Study Details of Ethics Committee Email sanwar@neemanasia.com Source of Monetary or Material Support > Angel Medical Systems 1163 Shrewsbury Avenue, Shrewsbury, NJ 07702 United States of America Type of Sponsor Max Neeman International List of Countries United States of America of Principal Investigator Dr Anil Saxena Dr Upendra Kaul Dr Rajeev Rathi Primary Sponsor Details Angel Medical Systems Inc 1163 Shrewsbury Avenue, Shrewsbury, NJ 07702 United States of America Pharmaceutical industry-global Max Neeman International Max House, 1 Dr. Jha marg, Okhla III, New Delhi-110020 of Site Site Phone/Fax/Email Escorts Heart Institute and research center Ltd. Fortis Flight Lt. Rajan Dhall Hospital Max Super Speciality Hospital, (A unit of Devki Devi Foundation) Associate Director, Escort Heart Institute and Research Centre, Okhla Road, New Delhi-110025, 91-9811150518 91-11-42776222 anil.saxena@hotmail.co m Department of 91-9811150518 Cardiology, Fortis Flight 91-11-42776222 Lt. Rajan Dhall ukaul@vsnl.com Hospital, Sector B, Pocket 1, Aruna Asaf Ali Marg, Vasant Kunj, New Delhi-110070, Department of Cardiology Max Super Speciality Hospital,2 Press enclave road, Saket, New Delhi- 100017, INDIA Dr Vinod Sharma National Heart institute Department Of Cardiology, National Heart institute Delhi 91-9910268009 91-11-26515050 rajeev.rathi@maxhealth care.com 011-466000700 drvs1994@rediffmail.co m of Committee Approval Status Date of Approval Is Independent Ethics Committee? Independent Ethics committee, Delhi,Escorts Heart Institute and Research Center Ltd Submittted/Under Review No Date Specified Yes page 2 / 6
Regulatory Clearance Status from DCGI Health Condition / Problems Studied Intervention / Comparator Agent Inclusion Criteria Independent Ethics committee, Fortis Flt.Lt. Rajan Dhall Hospital, Institutional Review Board of Max Super Specialty Hospital, Delhi Spect ERB, 119 State Bank Colony, G.T. Karnal Road Delhi,110009 Status Submittted/Under Review No Date Specified Yes Approved 12/07/2011 No Submittted/Under Review No Date Specified Date Notified 03/05/2011 Health Type Patients Condition Type Details Yes Myocardial Infarction, Acute Coronary Syndrome Intervention Angel Med Guardian System Angel Med Guardian System Comparator Agent Angel Med Guardian System The same device is in the comparator arm. Here, alerting in the comparator arm is switched off. Age From Age To Gender Details 21.00 Year(s) 99.00 Year(s) Both Inclusion Criteria Inclusion criteria All of the following criteria must be present: 1. Subject has at least one of the following conditions: a) Diabetes (Type I or Type II) b) Compromised renal function (Cr 1.2 mg/dl or creatinine clearance less than 50) c) TIMI Risk Score 3 2. Presents (within past 6 months) with a high-risk acute coronary syndrome (e.g., Unstable Angina, STEMI or NSTEMI) or has undergone or is scheduled for CABG within 6 months of implantation. 3. Has already undergone coronary angiography and revascularization, unless the physician determines it is appropriate to implant before or during the planned procedure. 4. Lives in a geographic area in close proximity (within 60 minutes by EMS) to any hospital that can treat AMI. 5. Subjects (men or women) at least 21 years of age. Women of childbearing age must have a negative pregnancy test or confirmation of one of the following: a) Post-menopause or amenorrheic during the past year b) Surgical sterilization c) Use of effective contraceptive method Exclusion Criteria Details Exclusion Criteria 1.In the investigators opinion, subject lacks ability to respond appropriately to alarms, e.g., illiteracy, poor memory or cognitive function, dementia or other condition affecting memory function, etc. 2.There is known compromised tissue at the site of lead implantation page 3 / 6
Method of Generating Random Sequence Method of Concealment Blinding/Masking Computer generated randomization Centralized Outcome Assessor Blinded in the apex of the right ventricle, e.g., prior infarct affecting the RV apex location. 3.A permanent pacemaker or ICD is already in place or the patient is indicated for ICD or pacemaker implantation based on the guidelines published by the American College of Cardiology as Class I and IIa recommendations. Class IIb recommendations are at the investigators discretion. 4.Subject cannot feel the IMD vibration when placed on top of the skin on the left pectoral side of the chest. 5.Subject has recurrent or persistent atrial fibrillation. 6.Subject has recurrent or persistent non-sinus cardiac rhythm, second or third degree atrioventricular blocks, QRS duration greater than 120 ms, Benign Early Repolarization (BER), or Brugada Syndrome. 7.Subject has left ventricular hypertrophy evidenced by EKG criteria. 8.Subject has any condition preventing the subcutaneous implantation of the Guardian System in a left pectoral pouch, such as: superior vena cava thrombosis, subcutaneous tissue deemed inappropriate for the procedure or prior central venous access via portacath, Hickman, Groshong, or similar placed in a left pectoral location or left side PICC line. 9.Subject has extremely heavy alcohol consumption (participates in binge drinking that leads to alcohol intoxication) or has history of alcohol or illicit drug abuse within past 5 years. 10.There is evidence of unresolved infection (fever 38o C and/or leukocytosis 15,000). 11.Subject has history of bleeding disorders or severe coagulopathy (platelets 100,000 plts/ml; APTT or PT 1.3 x reference range). 12.Subject has had a hemorrhagic stroke or transient ischemic attack (TIA) in the past 6 months. 13.Subject has other severe diseases, such as cancer or refractory congestive heart failure, associated with limitation of life expectancy (less than 1 year), which may lead to inadequate compliance to the protocol or confusing data interpretation. 14.Subject has clinical conditions such as heart diseases, difficult-to-control blood pressure, difficult-to-control insulin-dependent diabetes or serious prior infections attributed to the diabetes, or others that, at the investigators discretion, could seriously affect the subjects current clinical condition during study procedures. 15.Subject has previous participation in the DETECT Study, current participation or previous participation in another drug or device study in the past 30 days that conflicts with this study as determined by the study sponsor. 16.Subject has experienced gastro-intestinal hemorrhage in the past 6 months. 17.Subject has any situation in which the use of aspirin is contraindicated for at least 6 months. 18 Subject has epilepsy. 19.Subject has known severe allergies, e.g., peanut, bee sting, etc Primary Outcome Outcome Timepoints The primary objective is to determine that the Guardian System reduces the composite of: 1.Cardiac or unexplained death 2. New Q-wave MI 3.Time to door 2 hours for a thrombotic At 6 months page 4 / 6
coronary occlusion event Secondary Outcome Outcome Timepoints Target Sample Size the incidence of cardiac death or unexplained death during follow-up. the incidence of New Q-wave myocardial infarction in one or more distributions the time to door the time from symptom recognition to presentation at a medical facility for STEMI the time from the Guardian s ST shift detection to presentation at a medical facility for a thrombotic coronary occlusion event the incidence of any myocardial infarction To determine that implantation of the Guardian System will be associated with the detection of: a. A greater incidence of confirmed (fluoroscopy, IVUS, CT, or MRI) plaque ruptures (symptomatic and asymptomatic). b. A greater incidence of significant disease progression on coronary angiography, IVUS, or radiographic studies To demonstrate that the proportion of implanted subjects who are free from system-related complications at six months post programming is at least 90% Total Sample Size=1020 Sample Size from =100 Phase of Trial Phase 2/ Phase 3 Date of First Enrollment () Date of First Enrollment (Global) Estimated Duration of Trial Recruitment Status of Trial (Global) Recruitment Status of Trial () Publication Details Brief Summary 16/08/2011 12/12/2009 Years=3 Months=5 Days=0 Open to Recruitment Not Applicable none as yet At 6 months This is a randomized, prospective clinical investigation with blinded CORE laboratories, and an independent clinical events adjudication committee that will evaluate the effectiveness of the AngelMed Guardian System as compared with the standard of care in reducing the incidence of the composite of death, new Q-wave MI and presentation > 2 hours for thrombotic coronary occlusion events among subjects at a high-risk of recurrent myocardial infarction. The ALERTS Study will enroll subjects who have been identified as having a high risk of a MI due to ACS page 5 / 6
Powered by TCPDF (www.tcpdf.org) or bypass surgery. The subjects will be implanted with the Guardian System and will be randomized 1:1 to alerting and no alerting after implantation. Half of the subjects will be randomly assigned to the treatment group using the Guardian System with an EXD and alerting turned on and the other half assigned to the control group with the Guardian System alerting turned off, no EXD provided. Patients will know if their devices have alerting enabled. Subjects will return for follow-up visits at 7-14 days, 1, 3, and every 6 months until closure of the IDE. Clinical outcomes will be assessed over the course of the follow-up period (6 months). The CORE labs who analyze 12 lead EKG data and angiograms will be blinded to the subject grouping and clinical course data. Following 6 months follow-up, subjects in the no alerting group will be allowed to have their alerting turned on and an EXD provided page 6 / 6