DETERMINE (Defibrillators to Reduce Risk by Magnetic Resonance Imaging Evaluation) is a prospective, multicenter, randomized clinical trials in patients with coronary artery diseases and mild-to-moderate left ventricular dysfunction. 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.
The DETERMINE study is based on preliminary work done at Northwestern, Duke, 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.
Typical study includes 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 128×256, 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.
De-identified images, functional analyses including ventricular contours, and associated variables resulting from DETERMINE have been contributed to the CAP database, in compliance with HIPAA protocol.
- Daniel C. Lee – Northwestern University
- Rationale and design of the study (Kadish et al., 2009)