DETERMINE The DETERMINE trial is a multicenter, randomized study of patients with coronary artery disease and mild to moderate left ventricular impairment. IRB approval is currently ongoing and recruitment is due to begin in June 2007. The primary objective of the study is to test the hypothesis that implantable cardioverter defibrillator (ICD) therapy in combination with medical therapy, in patients with myocardial infarct greater than or equal to 15% of the left heart muscle mass (as measured by CMR), improves long term survival compared to medical therapy alone. The secondary endpoint is survival from mortality due to the onset of fatal cardiac rhythm disturbances. In addition to a 2-arm randomized trial, the study will also include a registry of non-randomized patients. The primary objective of the registry is to test the hypothesis that percent myocardial infarction as measured by CMR is a better predictor for sudden cardiac death than left ventricular ejection fraction.
The DETERMINE study is based on preliminary work done at Northwestern, Duke, and Johns Hopkins Universities and UCLA. This study will determine whether patients with a better reserved ejection fraction (EF) than most ICD patients, but who may represent a greater percentage of patients (due to damage involving greater than or equal to 15% of the left ventricular mass), may benefit from an ICD. At each field center, potential patients will undergo functional cine imaging together with late gadolinium enhancement imaging. This will include retrospectively gated SSFP cine imaging (typical thickness ≤ 10 mm, gap ≤ 2 mm, TR 30-50 ms, TE 1.6 ms, flip angle 60º, FOV 360 mm, image matrix 128x256, 25 frames, depending on heart rate and breath-hold duration). All cines are acquired during a breath-hold of 8-15 seconds duration. Sufficient short- axis slices will be acquired to cover the whole heart, as well as long-axis slices in the four chamber, two chamber and LV outflow tract views. Late gadolinium enhancement imaging will be performed using segmented spoiled gradient recalled echo imaging with an inversion recovery magnetization preparation, 10 to 20 minutes after intravenous injection of a gadolinium-based contrast agent (0.15 to 0.2 mMol/kg body weight). Delayed enhancement images will be acquired in the same planes and image-slice positions as the cine images.
The role of the DCVI’s MRI Core Lab is to: firstly, recommend the image acquisition protocol for the study (which will be implemented by all of the field centers); secondly, collect the image data-sets from the field centers; thirdly, perform ongoing quality assessment, with feedback to the field centers and training centers as appropriate; and fourthly, perform image analysis in order to calculate ejection fraction, LV mass and volumes, and infarct mass and infarct surface area. The results of these analyses will then be sent to the Study Lead Site and Clinical Coordinating Center at Northwestern University. De-identified images, functional analyses including ventricular contours, and associated variables resulting from DETERMINE will be contributed to the Cardiac Atlas database, in compliance with HIPAA protocol.
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