This study is now closed.
DETERMINE - Defibrillators to Reduce Risk by Magnetic Resonance Imaging Evaluation
Principal Investigator Name: Ronald Berger, M.D., Ph.D., F.A.C.C.
Study Coordinator Name: Elizabeth Robinson, R.N.
Principal Investigator Name: Ronald Berger, M.D., Ph.D., F.A.C.C.
Study Coordinator Name: Elizabeth Robinson, R.N.
Contact Phone: (410) 502 - 0517
Study Coordinator
Contact E-mail: erobin26@jhmi.edu
Study Coordinator
Study Short Title: DETERMINE
Study Long Title: Defibrillators to Reduce Risk by Magnetic Resonance Imaging Evaluation
IRB Number: JH-eIRB # NA_00013405
Funding Source: St. Jude Medical
Summary of Trial: To test the hypothesis that ICD therapy in combination with medical therapy in post MI patients with an infarct size > 10% of the LV mass improves long term survival compared to medical therapy alone. This is a randomized study of patients with CAD and mild to moderate LV dysfunction. Patients who do not meet the EF or infarct mass criteria may be placed in the study registry.
Inclusions:
- Evidence of CAD
- Evidence of prior MI
- LV dysfunction with EF > 35% (borderline EFs will be considered on a patient-by-patient basis)
- CE-MRI measure of infarct mass > 10% of LV mass
Exclusions:
- History of cardiac arrest or spontaneous or inducible sustained VT
- Currently implanted permanent pacemaker and/or pacemaker/ICD lead
- Need for revascularization based on investigator’s clinical assessment within the next 12 months (patient may be re-evaluated 90 days after revascularization)
- Recent MI (<40 days) or revascularization (<90 days)
- Antiarrhythmic drug therapy for ventricular arrhythmias
Clinical Trial Site:
Johns Hopkins University
600 N. Wolfe Street, Carnegie 586
Baltimore, MD 21287
Compensation for Participating? No, but parking passes will be distributed to assist with travel expenses.
Start Date: 2008
Anticipated End Date: 2013
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