Addition of FFRct in the diagnostic pathway of patients with stable chest pain to reduce unnecessary invasive coronary angiography
- Conditions
- major epicardial vessel stenosischest pain10011082
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 528
- 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.
- 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
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary endpoint is the percentage of unnecessary ICA at 90 days.<br /><br><br /><br>Unnecessary ICA is defined as an ICA without hemodynamically significant<br /><br>coronary artery disease (CAD).<br /><br>ICA with no hemodynamically significant CAD is defined as no invasive FFR <=<br /><br>0.80 or no iFR <= 0.89 in a coronary artery >= 2 mm;<br /><br><br /><br>or if FFR or iFR is not performed, no >= 50% stenosis on the quantitative<br /><br>coronary angiography (QCA) in a coronary >= 2 mm; or if QCA is also not<br /><br>available, no visual stenosis of >= 70% or in the case of the main stem no<br /><br>stenosis of >=50% in a coronary artery >= 2 mm.<br /><br></p><br>
- Secondary Outcome Measures
Name Time Method <p>• Percentage of unnecessary ICA after 1 year<br /><br><br /><br>The following endpoints are determined after 90 days and after 1 year:<br /><br>• Serious Adverse Cardiac Events (MACE), including all-cause mortality,<br /><br>non-fatal myocardial infarction (MI), and unplanned<br /><br>hospitalization leading to urgent revascularization<br /><br>• Cost-effectiveness analysis and budget impact analysis<br /><br>• Number of additional non-invasive tests for CAD assessment<br /><br>• All coronary revascularizations (planned / unplanned)<br /><br>•Quality of life<br /><br>• Cardiovascular mortality<br /><br>• Complications after ICA<br /><br>• Non-fatal stroke</p><br>
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