Health Condition 1: I251- Atherosclerotic heart disease of native coronary artery
Conditions
Interventions
None listed
Sponsors
SankhyaSutra Labs Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 18 years and above, Patients with a stable angina, Has already undergone an Invasive Coronary Angiogram (ICA) and invasive FFR measurement, Has had 64 or more slice multidetector row CTCA within 30 days prior to ICA, Can provide written informed consent
Exclusion criteria
Exclusion criteria: CT interpretation confounded by poor quality or artefacts or CAD-RADS N, CTCA indicates severe stenosis or 100% occlusion in at least one of the epicardial arteries, Prior CABG, PCI, myocardial infarction, HOCM, Stenosis in LMCA, Aortic stenosis, LV dysfunction, Unstable blood pressure with systolic Arrhythmia
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome of this study is the area under receiver operating characteristic curve (AUROC) for non-invasive fractional flow reserve (NIFFR) against clinical revascularisation decisions (guided by Invasive coronary angiography (ICA) and invasive fractional flow reserve (FFR)) with hemodynamically significant stenosis defined as being NIFFR less than or equal to 0.8.Timepoint: 6 months | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Pearson correlation coefficient (a measure of linear correlation between two sets of data) per vessel value of non-invasive fractional flow reserve (NIFFR) against invasive fractional flow reserve (FFR) in vessels with hemodynamically significant stenosis 2. Area under receiver operating characteristic curve (AUROC) of independent evaluations of (a) Coronary CT Angiogram (CTCA) and (b) Invasive Coronary Angiography (ICA), against clinical percutaneous coronary intervention (PCI) decision 3. Traditional measures of diagnostic accuracy such as sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) as a comparator of binary outcomes for the performance of CTCA, ICA and NIFFR 4. Cost-effectiveness of NIFFR in clinical practice vs ICA vs invasive FFR Timepoint: 6 months | — |
Countries
India
Contacts
Public ContactP Sunthar
IIT Bombay
Outcome results
None listed