Comprehensive Cardiac CT Versus Exercise Testing in Suspected Coronary Artery Disease (2) (CRESCENT2)

Multi-center, randomized-controlled trial comparing a comprehensive cardiac CT protocol with standard stress testing in patients with stable chest pain complaints.

Rationale: CT calcium and coronary lumen imaging allow efficient exclusion of coronary artery disease (CAD), but cannot assess the hemodynamic significance of obstructive findings. Addition of stress myocardial perfusion imaging, which assesses the functional relevance of coronary narrowing, completes the non-invasive cardiac evaluation. Hypothesis: A comprehensive cardiac CT examination will allow fast, accurate and complete evaluation of suspected CAD. Objective: evaluate the effectiveness and efficiency of comprehensive cardiac CT workup of suspected CAD. Study design: Open-labelled, randomized-controlled, clinical efficiency trial, with an intention-to-diagnose approach, between CT-guided management and the current standard of care (based on functional testing of provocable myocardial ischemia) in patients with suspected CAD. Study population: 250 patients (>18 yrs) with stable chest complaints, a >10% pre-test probability of CAD, and referred for evaluation of possible CAD. Intervention: Instead of the usual diagnostic approach, patients in the intervention group will undergo in sequence the following CT examinations: coronary calcium scan, coronary CT angiography and CT myocardial perfusion imaging, with completion dependent on results. Findings on CT will direct further management. Main study parameters/endpoints: Primary: Rate of negative invasive angiograms (as percentage of total population) Secondary: Diagnostic yield, chest complaints, quality of life, diagnostic and therapeutic procedures, overall costs and adverse events at 6 months.

Computed tomography, Coronary angiography, Coronary artery disease, Perfusion imaging, Comparative effectiveness, Randomized controlled trial, Cost-effectiveness

Tiered cardiac CT protocol: CT calcium scan CT angiography (if calcium scan positive or high pre-test probability) CT perfusion (if >50% stenosis on CTA, or cannot be ruled out)

Inclusion Criteria: Men and women aged >18 years. Chest pain symptoms suspicious of coronary heart disease. Pre-test probability of coronary artery disease >10% Exclusion Criteria: History of CAD: prior myocardial infarction or revascularization procedure Contra-indication to radiation exposure (CT/SPECT): pregnancy Contra-indication to iodine contrast media: renal failure, iodine allergy Contra-indications to adenosine Inability or unwillingness to provide informed consent.

Lubbers M, Coenen A, Kofflard M, Bruning T, Kietselaer B, Galema T, Kock M, Niezen A, Das M, van Gent M, van den Bos EJ, van Woerkens L, Musters P, Kooij S, Nous F, Budde R, Hunink M, Nieman K. Comprehensive Cardiac CT With Myocardial Perfusion Imaging Versus Functional Testing in Suspected Coronary Artery Disease: The Multicenter, Randomized CRESCENT-II Trial. JACC Cardiovasc Imaging. 2018 Nov;11(11):1625-1636. doi: 10.1016/j.jcmg.2017.10.010. Epub 2017 Dec 13.