Coronary artery disease I25.0
Conditions
Interventions
Group 1: Patients with a stable CAD and intermediate pretest probability receive a cardiac computed tomography scan. In the case of a conspicuous (pathological) cCTA finding, the next step is the inva
Sponsors
Volcano Europe BVBA/SPRL
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: • Clinical indication for cCTA. • Indication for invasive assessment of coronary lesion depending on the result of the cCTA. • Stable coronary heart disease with coronary stenosis of unclear hemodynamic relevance.
Exclusion criteria
Exclusion criteria: Significant valvular pathology • Hemodynamic instability at the time of intervention • High sensitive troponin I (>0,2 ng/ml) • Severe vessel tortuosity and/or severe calcification by angiogram • Time between cCTA and ICA procedures exceeding 1 month • Contraindications for a cCTA/ICA (e.g. allergy to contrast agents, renal failure) • Severely reduced left ventricular function • Patients with prior coronary artery bypass grafting (CABG) • Bifurcation stenosis types D to G (SYNTAX score classification) • Severe stenosis of the proximal left main and/or the proximal right coronary artery • Percutaneous coronary stent implantation in the vessel of interest • Inadequate image quality of the cCTA dataset
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Diagnostic accuracy (sensitivity, specificity, negative predictive value, positive predictive value) of non invasive CT-FFR compared to invasive catheterbased iFR® in patients suspicious for coronacry artery disease. Both exams will be performed shortely after each other. | — |
Secondary
| Measure | Time frame |
|---|---|
| Clinical practicability of CT-FFR. | — |
Countries
Germany
Contacts
Public ContactDirk Loßnitzer
Universitätsklinikum Mannheim I. Medizinische Klinik
Outcome results
None listed