SMARTool clinical and biohumoral results. Chiara Caselli IFC-CNR
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1 SMARTool clinical and biohumoral results Chiara Caselli IFC-CNR
2 SMARTool Flow chart EVINCI and ARTreat Populations
3 SMARTool: WP1 and WP2 WP1 Objective: To collect retrospective EVINCI clinical and imaging data from 515 patients; To select SMARTool patients (N= ) from existing EVINCI and ARTReat clinical/imaging data; To submit enrolled SMARTool patients to non-invasive CCTA testing. Task 1.1 Clinical and imaging (CCTA) data collection and selection (retrospective/baseline collection and acquisition at follow-up) (Leader FTGM, Participating partners CNR, LUMC, UTU, UZH, B3D) WP2 Objective: To collect the non-imaging (clinical, biohumoral, molecular) data from baseline and follow-up samples Task 2.1: Biohumoral data collection and analysis at baseline and at follow-up (Leader CNR, Participating partners FTGM, UTU, UZH)
4 Clinical features CLINICAL FEATURES Baseline n= 263 Follow up n= 263 P value Baseline vs Follow up DEMOGRAPHICS RISK FACTORS PHARMACOLOGICAL TREATMENT CURRENT SYMPTOMS Age (yrs) < Gender (males) 165 (63) 165 (63) --- Family history of CAD 125 (48) 125 (48) --- Hypertension 163 (65) 188 (76) < Diabetes 50 (20) 69 (28) < Increased prevalence/recognition of Risk Factors Hypercholesterolemia 172 (70) 199 (81) < Smoking 40 (16) 28 (11) < Obesity 52 (21) 64 (26) < Beta-blockers 107 (45) 115 (48) < Calcium antagonists 36 (15) 60 (25) < ARBs/ACE Inhibitors 128 (48) 137 (52) < Increased treatment of Risk Factors and Ischemia Diuretics 39 (16) 43 (18) < Nitrates 22 (9) 18 (7) Oral anti-diabetics 35 (15) 61 (26) < Insulin 11 (5) 14 (6) < Statins 127 (53) 166 (67) < Aspirin 158 (66) 146 (61) Typical angina 67 (30) 19 (9) Atypical angina 107 (48) 31 (14) No symptoms 20 (9) 141 (64) Other symptoms 28 (13) 30 (13) Decreased Symptoms 0.007
5 Bio-humoral markers LIPIDS Total cholesterol LDL and HDL cholesterol Triglycerides INFLAMMATION hs CRP Interleukin-6 CARDIAC DAMAGE hs ctnt HEPATIC FUNCTION AST, ALT ALP, GGT THYROID FUNCTION TSH ft3, ft4 METABOLISM Glucose Creatinine Leptin ENDOTHELIAL ACTIVATION sicam svcam CARDIAC FUNCTION NT-proBNP VASCULAR REMODELING MMP2 MMP9 4/15
6 Pathway Biohumoral Profile BIOMARKER Baseline N=263 Follow up N=263 P value Baseline vs Follow up Total cholesterol (mg/dl) ns LIPIDS METABOLISM INFLAMMATION/ ENDOTHELIAL ACTIVATION HEPATIC FUNCTION CARDIAC MARKERS THYROID FUNCTION VASCULAR REMODELING LDL (mg/dl) < HDL (mg/dl) < Triglycerides (mg/dl) < Leptin (ng/ml) < Glucose (mg/dl) ns Creatinine (mg/dl) ,20 0,.86 0,22 ns hs CRP (mg/dl) 0.36± ±0.47 ns Interleukin-6 (pg/ml) 1.09± ±3.44 < svcam (ng/ml) ± ± < sicam (ng/ml) ± ±75.80 ns AST (U/L) ns ALT (U/L) ALP (U/L) GGT (U/L) hs cardiac Troponin T (ng/ml) 7.54± ns NT-proBNP (ng/ml) ± 9.67 nd TSH (mui/ml) nd ft3 (pg/ml) nd ft4 (pg/ml) nd MMP2 (ng/ml) ±57.36 nd MMP9 (ng/ml) ± nd
7 Summing Up 1 BASELINE vs FOLLOW UP Statin treatment LDL Cholesterol IMPROVEMENT OF LIPID PROFILE Diabetes Triglycerides Leptin STILL ALTERED METABOLIC PROFILE Interleukin 6 svcam WORSENING OF INFLAMMATORY PROFILE
8 Coronary Artery Disease at CCTA Baseline Follow up P value Baseline vs Follow up N=263 Uninterpretable 6 (2) 5 (2) No CAD 52 (19) 38 (15) Not Obstructive CAD 145 (56) 165 (62) (stenosis < 50% of major segments) < Obstructive CAD (stenosis 50% of major segments) 60 (23) 55 (21) Increased Coronary ATS Burden Number of Plaques < Leiden Risk Score < N=211 Total Plaque Volume <0.0001
9 LEIDEN RISK SCORE A B F D C E De Graaf M et al., /15
10 Association with CAD Leiden Risk Score Baseline Follow up Class 0 (0-5) N=82 Class 1 (5-20) N=127 Class 2 (>20) N=48 P Value Class 0 (0-5) N=61 Class 1 (5-20) N=131 Class 2 (>20) N=65 P Value DEMOGRAPHICS Age Male gender 33 (40%) 90 (71%) 38 (79%) < (31%) 87 (66%) 55 (84%) < HDL Diabetes mellitus 7 (8%) 22 (17%) 17 (35%) (15%) 29 (22%) 28 (43%) METABOLISM Creatinin Glucose Leptin INFLAMMATION/ ENDOTHELIAL ACTIVATION CARDIAC DAMAGE Interleukin ns svcam ns hs ctnt <0.0001
11 SUMMING UP 2 Predicting CAD Presence/Severity/Risk BASELINE vs FOLLOW UP Diabetes and biomarkers of metabolic syndrome, such as HDL, glucose and leptin levels, are associated with CAD (presence/severity/risk) at baseline and follow up ABNORMAL METABOLISM IS A PERSISTENT DETERMINANT OF CAD Biomarkers of inflammation and endothelial activation, such as IL-6 and svcam, are associated with CAD (presence/severity/risk) at follow up INFLAMMATION IS AN ADDITIONAL DETERMINANT OF CAD
12 Association with CAD Progression N = 66 Revascularized Baseline Variables Plaque Number Increase N=101/193 Leiden score Increase N=106/193 TPV Increase N=74/149 HR (95% CI) P Value HR (95% CI) P Value HR (95% CI) P Value METABOLISM ALT 2.03 ( ) ( ) ( ) Leptin 0.72 ( ) ( ) ( ) INFLAMMATION Interleukin ( ) ( ) ( ) VASCULAR REMODELING THYROID FUNCTION MMP ( ) ( ) ( ) <0.001 ft ( ) ( )
13 SUMMING UP 3 CAD PROGRESSION ALT and leptin, are associated with CAD PROGRESSION ABNORMAL METABOLISM Interleukin 6 is associated with CAD PROGRESSION INFLAMMATION MMP9 and ft4, are additionally associated with CAD PROGRESSION VASCULAR REMODELING AND THYROID FUNCTION
14 SMARTool Flow chart PRE IMAGING MODULE (PIM) Multiscale/multilevel model of plaque formation/progression CLINICAL DECISION SUPPORT SYSTEM (CDSS)
15 INSIGHTS FROM PRELIMINARY RESULTS After 6.2±1.4 yrs of Follow up, in the SMARTool population: DYSLIPIDEMIA is effectively improved by lipid lowering treatment ABNORMAL METABOLISM remains a persistent determinant of CAD severity and progression (PURE Study, Lancet 2017) INFLAMMATION is an emerging determinant of CAD Risk and a potentially new therapeutic target (CANTOS trial, NEJM 2017); VASCULAR REMODELING AND THYROID FUNCTION might have a role as new biomarkers of CAD progression
16 THANKS FOR YOUR ATTENTION
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