Statistical Analysis Plan for the Cardiac Magnetic Resonance GUIDEd Management of Mild-moderate Left Ventricular Systolic Dysfunction (CMR GUIDE) trial
Billot, L.; Gore, J.; Atherton, J.; Berry, C.; Brachmann, J.; Ganesan, A.; Hillis, G.; Jung, W.; Prasad, S.; Selvanayagam, J.
Show abstract
The CMR Guide trial aims to determine whether the insertion of an Implantable Cardioverter Defibrillator based on the presence of ventricular scar/fibrosis will reduce sudden cardiac death or syncopal ventricular arrhythmia in patients with mild moderate left ventricle systolic dysfunction compared to standard care. This statistical analysis plan pre-specifies the method of analysis for every outcome and key variables collected in the trial. The primary outcome is a composite of sudden cardiac death or haemodynamically significant ventricular arrhythmia defined as ventricular arrhythmia producing syncope (loss of consciousness) or associated with hypotension (SBP<90mmHg) except directly associated with device implant procedure. The main analysis will consist of a Fine and Gray survival model of time to first occurrence of a primary outcome treating deaths other than sudden cardiac deaths as competing risks. The analysis plan also includes planned sensitivity analyses including covariate adjustments and subgroup analyses.
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