Comparison of a software-based non-invasive diagnosis against catheter-based invasive methods to find the extent of blood flow reduction due to heart blockages (JENIFFER)
Not Applicable
- Conditions
- Health Condition 1: I251- Atherosclerotic heart disease of native coronary artery
- Registration Number
- CTRI/2022/04/042135
- Lead Sponsor
- SankhyaSutra Labs Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Other (Terminated)
- Sex
- Not specified
- Target Recruitment
- 10
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
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 <90 mmHg,
Arrhythmia
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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 <br/ ><br>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 <br/ ><br>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 <br/ ><br>and NIFFR <br/ ><br>4. Cost-effectiveness of NIFFR in clinical practice vs ICA vs invasive FFR <br/ ><br>Timepoint: 6 months