Replacement of invasive diagnostic coronary procedures by innovative noninvasive Imaging Technologies

Coronary Artery Disease (CAD) is expected to remain the leading cause of death for the next 20 years, posing a major burden on society. A considerable proportion of costs related to the management of (suspected) CAD are due to Invasive Coronary Angiography (ICA), which is indicated in high-risk patients and in patients with noninvasive testing suggestive of significant CAD. Noninvasive imaging techniques show promising potential to replace a large proportion of the current practice of ICA. The REPLACE-IT study is a prospective single-centre observational study with the aim to establish a noninvasive, quantitative imaging approach to (1.) determine if flow or perfusion-limiting CAD is present, (2.) guide the indication for percutaneous intervention or bypass grafting, and (3.) predict the hemodynamic improvement after revascularization. Non-acute, symptomatic patients scheduled to undergo elective ICA are eligible for this study. In total 440 men and women (aiming to include equal numbers by gender) will be recruited from the cardiology outpatient clinic at the UMCG, where we see approximately 2500 eligible patients annually. Patients will undergo a diagnostic algorithm consisting of coronary (Computed Tomography Angiogram) CTA and myocardialMagnetic Resonance (MR) perfusion before ICA. A second MR perfusion will be performed only when the patient received a coronary intervention. The primary endpoint is the comparison of noninvasive imaging (combined CTA and MR perfusion) to diagnose flow limiting CAD with reference standard of ICA+/-FFR. Secondary endpoints include the performance of individual components of the noninvasive imaging approach, the ability to guide revascularization strategy and the prediction of improvement of perfusion after revascularization. We expect to establish a noninvasive imaging approach to reduce the number of ICA.

The hypothesis is that non invasive imaging techniques (CTA + stress MR perfusion) are a suitable replacement for diagnostic Invasive Coronary Angiography (ICA) in the diagnosis of Coronary Artery Disease.

01-11-18: Start inclusion

01-12-19: 100 patients included

01-12-21: 400 patients included

01-06-22: Final results

Before ICA patients will undergo both CT Coronary Angiography (CTA) and adenosine MR perfusion imaging. In case of significant CAD during ICA, a second MR perfusion scan after the intervention will