Addition of FFRct in the Diagnostic Pathway of Patients With Stable Chest Pain
Addition of FFRct in the Diagnostic Pathway of Patients With Stable Chest Pain to Reduce Unnecessary Invasive Coronary Angiography
Erasmus Medical Center
528 participants
Jul 27, 2021
INTERVENTIONAL
Conditions
Summary
Rationale: Patients with stable chest pain enter a diagnostic pathway where Coronary Computed Tomography Angiography (CCTA) is often the first line non-invasive test to detect coronary stenosis. An anatomically significant (≥ 50% luminal narrowing) stenosis on CCTA does however not always cause cardiac ischemia (i.e. hemodynamically significant stenosis). CCTA is often followed by invasive coronary angiography (ICA) to assess the hemodynamic significance of the stenosis which is the key determinant to decide on treatment (revascularization by coronary stenting or surgery). CCTA has a very high negative predictive value but the positive predictive value is moderate. Hence, anatomically significant stenoses on CCTA often turn out not to be hemodynamically significant on ICA. Fractional Flow Reserve from coronary computed tomography (FFRct) analysis is a new non-invasive technique that uses the CCTA images as a basis for complex software based calculations and modelling to provide additional functional information based on the anatomical CCTA images. Thus, FFRct is a totally non-invasive method. Adding the FFRct analysis to the anatomical assessment of CCTA is expected to reduce the number of patients being referred to ICA where no signs of hemodynamically significant stenosis are found on ICA.
Eligibility
Inclusion Criteria2
- 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 Criteria8
- 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
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Interventions
Software analysis of Cardiac CT to show extent of pericardial stenoses
Locations(1)
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NCT05174247