major epicardial vessel stenosis
Conditions
Interventions
None listed
Sponsors
Erasmus MC, Universitair Medisch Centrum Rotterdam
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - Age >= 18 years - Stable chest pain and the patient underwent CCTA which demonstrated >=*50% but less than 90% stenosis in any major epicardial vessel with a diameter >= 2 mm.
Exclusion criteria
Exclusion criteria: - Inability to provide informed consent - Unstable angina according to ESC guidelines - Unstable clinical status - Expected inability to complete follow-up and comply with follow-up aspects of the protocol - History of coronary revascularisation - Non-invasive or invasive diagnostic testing for CAD within the past 12 months (with the exception of exercise ECG) - Unsuitable for revascularisation if required (for example due to comorbidities or anatomical features) - Poor CT quality with expected inability to perform FFRct analysis
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint is the percentage of unnecessary ICA at 90 days. Unnecessary ICA is defined as an ICA without hemodynamically significant coronary artery disease (CAD). ICA with no hemodynamically significant CAD is defined as no invasive FFR = 2 mm; or if FFR or iFR is not performed, no >= 50% stenosis on the quantitative coronary angiography (QCA) in a coronary >= 2 mm; or if QCA is also not available, no visual stenosis of >= 70% or in the case of the main stem no stenosis of >=50% in a coronary artery >= 2 mm. | — |
Secondary
| Measure | Time frame |
|---|---|
| • Percentage of unnecessary ICA after 1 year The following endpoints are determined after 90 days and after 1 year: • Serious Adverse Cardiac Events (MACE), including all-cause mortality, non-fatal myocardial infarction (MI), and unplanned hospitalization leading to urgent revascularization • Cost-effectiveness analysis and budget impact analysis • Number of additional non-invasive tests for CAD assessment • All coronary revascularizations (planned / unplanned) •Quality of life • Cardiovascular mortality • Complications after ICA • Non-fatal stroke | — |
Countries
Netherlands
Outcome results
None listed