Title: Benefit to patients and the NHS of cardiac magnetic resonance imaging (CMR) after Primary percutaneous coronary Intervention (PPCI) Pathway Activation
Funder: Department of Health (England)

Abstract: This is a prospective multi-centre feasibility cohort study to document the use of CMR in patients who present as ST-elevation myocardial infarction (STEMI) and are referred for PPCI. We will request prospective informed consent from approximately 1600 of these patients (including those found not to have had a STEMI i.e. patients whose arteries are found to be unblocked and therefore do not require PPCI). The study will take place in four NHS 24/7 PPCI centres. Two will be “CMR centres” i.e. centres that perform routine CMR examination in patients. The other two will be “non-CMR centres” i.e. centres that do not perform routine CMR examinations (due to lack of adequate equipment and / or expertise).The aim of the study is to evaluate the feasibility of setting up a UK multicentre registry to document CMR use in patients presenting as STEMI and referred for PPCI. There are three elements to the study listed below with their associated objectives: A.To determine whether it is feasible to set up a CMR registry in this patient population by linking sources of routinely collected data in four PPCI centres. Objective 1: To provide evidence of whether data linkage and extraction can be carried out across four PPCI centres; Objective 2: To implement consent and establish patient consent rate; B.To estimate the proportion of PPCI patients who have CMR at two centres with dedicated CMR facilities and describe resource use and associated costs of having CMR after PPCI. Objective 1: To estimate the proportion of STEMI patients who get a CMR scan following PPCI; Objective 2: To describe resource use and associated costs of having CMR after PPCI; C.To identify an outcome measure representing a definitive change in clinical management conditional on having had CMR that would be credible to cardiologists and other stakeholders as a measure of the “value-added” by doing CMR. Objective 1: To define using formal consensus methods a treatment / process outcome that will constitute a definitive change in clinical management arising from having CMR; Objective 2: To identify patient subgroups in whom CMR use is indicated using formal consensus methods and illustrative data from the registry. Conditional on the success of achieving objectives for study elements A B and C a final objective D will be to define the research objectives and calculate the sample size needed for a registry that would be able to achieve the longer-term aim of evaluating the effectiveness and cost-effectiveness of CMR after PPCI.Key data items (basic demography clinical characteristics and biochemistry on presentation peri- and post-procedural characteristics any imaging tests used post PPCI and subsequent NHS activity / resource use following PPCI) will be collected by linking patient information from local NHS clinical systems and national databases. Data will be linked within the originating site and submitted to the database (which will be developed and maintained at Bristol). In order to meet objective C1 we will recruit a panel of interventional cardiologists commissioners and cardiac network representatives (12 in total) and use a formal consensus method based on the modified nominal group technique to specify a ‘proxy’ outcome that will constitute a definitive management change initiated by CMR. This will involve a three stage process; a face-to-face meeting and completing a pre-defined evaluation form with statements relating to the need for CMR on two occasions. Health economic analyses will be undertaken by the Health Economics Research Centre at the University of Oxford.


Research activity codes: 5.3 MEDICAL DEVICES
Health categories: CARDIOVASCULAR