Comprehensive Cardiac CT versus Exercise Testing in Suspected Coronary Artery Disease (CRESCENT II Trial)
Completed
- Conditions
- Coronary disease10011082
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 250
Inclusion Criteria
Stable chest pain, requiring evaluation of coronary artery disease
Exclusion Criteria
History of CAD: prior myocardial infarction or revascularization procedure (CABG or PCI)
Contra-indication to radiation exposure (CT/SPECT): pregnancy
Contra-indication to iodine contrast media: renal failure, iodine allergy
Contra-indications to adenosine
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Rate of negative invasive catheterization procedures (superiority)<br /><br>Proportion of invasive angiograms without relevant coronary artery disease. A<br /><br>positive invasive angiogram is defined as: CAD with a class I indication for<br /><br>myocardial revascularization, in accordance with clinical guidelines [Wijns].<br /><br>This indication will be assessed independently, in a blinded fashion,<br /><br>regardless of the clinical decision made by the treating physician:<br /><br>* Left main coronary stenosis >50% with objective ischemia.<br /><br>* Proximal LAD stenosis >50% with objective ischemia.<br /><br>* Two or three vessel disease with impaired LV function and objective ischemia.<br /><br>* Proven large area of ischemia (>10% LV)<br /><br>* Any stenosis >50% with limiting anginal symptoms unresponsive to optimal<br /><br>medical treatment. </p><br>
- Secondary Outcome Measures
Name Time Method <p>* Number of patients with class I coronary artery disease on invasive<br /><br>angiography<br /><br>* Positive yield of invasive coronary angiography: proportion angiograms with<br /><br>class I CAD.<br /><br>* Number of diagnostic procedures and related expenses per patient (at 6<br /><br>months).<br /><br>* Therapeutical expenses (medication, revascularizations) per patient (at 6<br /><br>months).<br /><br>* Overall medical expenses (at 6 months).<br /><br>* Time until (final) diagnosis and treatment decision.<br /><br>* Chest pain symptoms and quality of life (at six months).<br /><br>* Composite major adverse event rate: cardiac death, non-fatal acute coronary<br /><br>syndrome, cerebro-vascular events.<br /><br>* Cost-effectiveness (incremental cost-effectiveness ratio, net health benefit)<br /><br>* Proportion of tests with diagnostic results<br /><br>* Cumulative radiation exposure<br /><br>* Diagnostic complications: allergic reactions, bleeding, arrhythmia, renal<br /><br>dysfunction. </p><br>