Complete Versus Lesion-only Primary PCI pilot -Cardiac MRI sub study (CVLPRI-t-CMR)

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Scientific Abstract|DESIGN: CVLPRI-t: Multi-centre, open, pilot, randomized, controlled clinical trial. CVLPRI-t-CMR: + blinded endpoint analysis|POPULATION: 250 patients with ST elevation myocardial infarction(MI) undergoing primary percutaneous angioplasty (P-PCI) with multi-vessel coronary artery disease.|INTERVENTION: Complete in-hospital revascularisation with PCI (infarct-related artery and major coronary vessels (> 2.0mm) with severe stenosis) and optimal medical therapy (OMT).|COMPARATOR: Infarct related P-PCI only with OMT. Further revascularisation for refractory angina despite OMT or ischaemic burden >20% of total myocardium on non-invasive imaging.|OUTCOME MEASURES: Main CULPRIT study: Major adverse cardiac events: all-cause death, recurrent MI, heart failure, need for revascularization (PCI or CABG) at 12 months|CMR substudy (BLINDED ENDPOINTS) Primary: 1. MI size (% of LV mass) on pre-discharge CMR. Secondary: 1. Myocardial salvage index, extent of microvascular obstruction, ejection fraction (EF) and left ventricular(LV) end diastolic(EDV) and systolic volumes(ESV), pre-discharge CMR. 2. LVEDV, ESV, EF and ischaemic burden on CMR at 9 months. |ASSESSMENT AND FOLLOW-UP: CMR will be performed pre-discharge (1-4 days) post MI and at 9 months. Clinical assessments for MACE at 3,6, 9 and 12 months (endpoints). |PROPOSED SAMPLE SIZE: It is anticipated the main study will recruit in total 250 patients. For the CMR study it is likely not all will be eligible/consent to CMR. 100 patients in each arm has 80% power to detect an absolute 4% difference in infarct size assuming infarct size 20 (10)% of LV mass, in culprit-only revascularisation, alpha=0.05 and 2-tailed.|STATISTICAL ANALYSIS: Analysis will be performed by a statistician from the CTEU at the Royal Brompton Hospital (supported by Imperial CTEU). Groups will be compared by 2 sample t-tests/Fishers exact test and Chi-square as appropriate and will be by intention to treat. Event free survival will be assessed by Kaplan-Meier curves. Univariate predictors of outcome will be assessed by logistic regression analysis and independent predictors by multivariate analysis. The trial will be overseen by a trial steering committee and an independent data and safety monitoring board with planned sub group analysis when 60 patients in each arm have been recruited.|PROJECT TIMETABLES AND RECRUITMENT RATE: The main CULPRIt clinical study without CMR has funding from the BHF. Ethics submission August 2010, recruitment starting in October 2010. It is anticipated that 6 patients per week (1.5/centre) will be recruited and completed within 9 months (June 2011) with a further follow-up of 12 months (June 2012) and 3 months for analysis/writing up (Sept. 2012). |