Design and rationale of the MR-INFORM study: stress perfusion cardiovascular magnetic resonance imaging to guide the management of patients with stable coronary artery disease
1 King’s College London, British Heart Foundation (BHF) Centre of Research Excellence, National Institute for Health Research (NIHR) Biomedical Research Centre at Guy’s and St. Thomas’ NHS Trust Foundation, Joint Imaging and Cardiovascular Divisions, Kings Health Partners, 4th Floor Lambeth Wing, St. Thomas' Hospital, London, SE1 7EH, UK
2 Multidisciplinary Cardiovascular Research Centre & Leeds Institute of Genetics, Health and Therapeutics, University of Leeds, Leeds, United Kingdom
3 NIHR Leicester Cardiovascular Biomedical Research Unit, Leicester, UK
4 The London Chest Hospital, London, UK
5 Department of Cardiology and Pneumology and Heart Research Center, Georg-August-University, Göttingen, Germany
Journal of Cardiovascular Magnetic Resonance 2012, 14:65 doi:10.1186/1532-429X-14-65Published: 19 September 2012
In patients with stable coronary artery disease (CAD), decisions regarding revascularisation are primarily driven by the severity and extent of coronary luminal stenoses as determined by invasive coronary angiography. More recently, revascularisation decisions based on invasive fractional flow reserve (FFR) have shown improved event free survival. Cardiovascular magnetic resonance (CMR) perfusion imaging has been shown to be non-inferior to nuclear perfusion imaging in a multi-centre setting and superior in a single centre trial. In addition, it is similar to invasively determined FFR and therefore has the potential to become the non-invasive test of choice to determine need for revascularisation.
The MR-INFORM study is a prospective, multi-centre, randomised controlled non-inferiority, outcome trial. The objective is to compare the efficacy of two investigative strategies for the management of patients with suspected CAD. Patients presenting with stable angina are randomised into two groups: 1) The FFR-INFORMED group has subsequent management decisions guided by coronary angiography and fractional flow reserve measurements. 2) The MR-INFORMED group has decisions guided by stress perfusion CMR. The primary end-point will be the occurrence of major adverse cardiac events (death, myocardial infarction and repeat revascularisation) at one year. Clinical trials.gov identifier NCT01236807.
MR INFORM will assess whether an initial strategy of CMR perfusion is non-inferior to invasive angiography supplemented by FFR measurements to guide the management of patients with stable coronary artery disease. Non-inferiority of CMR perfusion imaging to the current invasive reference standard (FFR) would establish CMR perfusion imaging as an attractive non-invasive alternative to current diagnostic pathways.