Clinical outcomes and cost-effectiveness of a diagnostic and treatment strategy of upfront CTCA plus selective non-invasive functional imaging compared with standard care in patients with chest pain and suspected Coronary Artery Disease (CLEAR-CAD)

Rationale: Patients with chest pain usually undergo multiple diagnostic examinations to demonstrate or rule out atherosclerotic coronary artery disease (CAD). In addition to high healthcare costs, some of the examinations do not assess the presence of CAD, which means that patients may be undertreated and are at risk for myocardial infarction. We hypothesize that a uniform diagnostic and treatment strategy that uses computed tomography coronary angiography (CTCA) as initial examination may reduce major adverse cardiac events (MACE) as well as healthcare costs. In addition, we hypothesize that this strategy improves angina-related health status and reduces the number of invasive coronary angiograms (ICA).

Objectives: 

• To show that the intervention is non-inferior to the control with regards to clinical outcomes
• To show superiority of the intervention with regard to clinical outcomes

Study design: National multicenter prospective randomized controlled trial.

Study population: Patients with chest pain, suspected for stable CAD.

Intervention: Upfront CTCA to diagnose CAD and guide optimal medical therapy (OMT). Patients with obstructive CAD and refractory angina despite OMT will undergo non-invasive ischemia imaging to guide revascularization.

Control: Standard of care. Diagnosis and treatment are at the discretion of the attending cardiologist.

Main study end point: Composite of all-cause mortality and non-fatal myocardial infarction.