DEfibrillators To REduce Risk by MagnetIc ResoNance Imaging Evaluation

Stopped early · Not applicable

Conditions studied: Coronary Artery Disease, Left Ventricular Dysfunction, Sudden Cardiac Death

In brief

This trial is a prospective, multi-center, randomized study of patients with coronary artery disease (CAD) and mild to moderate left ventricular (LV) dysfunction. The primary objective of this study is to test the hypothesis that Implantable Cardioverter Defibrillator (ICD) therapy in combination with medical therapy in patients with an infarct size greater than or equal to 10% of the left ventricular mass improves long term survival compared to medical therapy alone. In addition to the 2-arm randomized trial, the study will also include a non-investigational registry of non-randomized patients.

Key facts

Study ID

NCT00487279

Run by

Abbott Medical Devices

People needed

81

Starts

2007-06-01

Expected to finish

2011-04-01

Last updated by the study team

2019-02-05

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Randomized Arm
• Evidence of Coronary Artery Disease (CAD)a.
• Evidence of prior Myocardial Infarction defined by either:
• A. Clinical history of prior myocardial infarction OR B. Mild-moderate systolic LV dysfunction with an EF ≤50%
• LVEF>35% by any current standard evaluation technique (e.g., echocardiogram, MUGA, angiography).
• Patients who have an EF between 30-35% and NYHA Class I heart failure who do not have a history of ventricular tachyarrhythmias, or inducible ventricular tachycardia during electrophysiological (EP) testing can be enrolled (Target Population).
• CE-MRI measure of infarct mass > 10% of LV mass (as measured by the MRI core lab)
• If CE-MRI performed ≤ 40 days after myocardial infarction infarct mass must be ≥ 15% of the LV mass.
• Patients aged 18 years or above
• CAD will be confirmed by evidence of one of the following three (3) criteria 1) Prior myocardial infarction, 2) Significant stenosis of a major epicardial vessel (>50% proximal or 70% distal) by coronary angiography, 3) Prior revascularization (percutaneous coronary intervention or coronary artery bypass surgery. Patients may not be randomized until 90 days after revascularization.
• MI should be documented by the presence of two (2) of the following three (3) criteria: 1) Symptoms consistent with myocardial infarction (i.e. chest pain, shortness of breath), 2) Q-waves on electrocardiogram and 3) Elevated cardiac enzymes (CPK elevation > two times or troponin elevation > three times the upper limit of normal for the lab). Patients may not be randomized until 40 days after myocardial infarction.

You may not qualify if…

• History of cardiac arrest or spontaneous or inducible sustained VT (15 beats or more at a rate of 120 BPM or greater)*
• Unexplained syncope
• Need for revascularization based on investigator's clinical assessment within the next 12 months (patients may be reevaluated 90 days after revascularization)
• Currently implanted permanent pacemaker and/or pacemaker/ICD lead
• Contraindication to a ICD implant (i.e. inadequate venous access, bleeding disorder)
• Acute or chronic severe renal insufficiency (< 30mL/min/1.73m2); acute renal insufficiency of any severity due to hepato-renal syndrome
• Current or planned renal or liver transplant
• End stage renal disease on hemodialysis or peritoneal dialysis
• Contraindication to CE-MRI or history of allergy to gadolinium-based contrast dye
• Metal fragments in the eyes or face, implantation of any electronic devices such as (but not limited to) cardiac pacemakers, cardiac defibrillators, cochlear implants or nerve stimulators, surgery on the blood vessels of the brain, body piercing
• Recent MI (<40 days) or revascularization (<90 days)
• CVA within 90 days
• Antiarrhythmic drug therapy for ventricular arrhythmias
• New York Heart Association CHF functional class IV at enrollment
• Non-Investigational Registry Inclusion Criteria
• Evidence of CAD a with either a history of prior myocardial infarction OR any LV dysfunction
• Evidence of LV dysfunction (ejection fraction) as measured by any current standard screening technique (e.g., echocardiogram, MUGA, angiography).c
• Clinical CE-MRI within the past 12 months (scheduled or completed)
• Patients aged 18 years or above
• CAD will be confirmed by evidence of one of the following three (3) criteria 1) Prior myocardial infarction, 2) Significant stenosis of a major epicardial vessel (>50% proximal or 70% distal) by coronary angiography, 3) Prior revascularization (percutaneous coronary intervention or coronary artery bypass surgery.
• MI should be documented by the presence of two (2) of the following three (3) criteria: 1) Symptoms consistent with myocardial infarction (i.e. chest pain, shortness of breath), 2) Q-waves on electrocardiogram and 3) Elevated cardiac enzymes (CPK elevation > two times or troponin elevation > three times the upper limit of normal for the lab).
• Patients can be enrolled in the registry even if they have received or are about to receive an ICD for primary prevention.
• Exclusion Criteria
• History of cardiac arrest or spontaneous or inducible sustained VT (15 beats or more at a rate of 120BPM or greater)*
• Contraindication to CE-MRI or history of allergy to gadolinium-based contrast

Where it is running

• University of Arizona — Tucson, Arizona, United States
• Glendale Memorial Hospital and Health Center — Glendale, California, United States
• Long Beach Memorial Medical Center — Long Beach, California, United States
• Hollywood Presbyterian Medical Center — Los Angeles, California, United States
• UCLA Medical Center — Los Angeles, California, United States
• Hoag Memorial Hospital Presbyterian and Radin Inc. — Newport Beach, California, United States
• Catholic Healthcare West (d/b/a mercy General Hospital) and Regional Cardiology Associates — Sacramento, California, United States
• Rocky Mountain Cardiovascular Associates — Denver, Colorado, United States
• University of Florida-Shands/Jacksonville — Jacksonville, Florida, United States
• Orlando Regional Healthcare System — Orlando, Florida, United States
• Cardiology Consultants of Northwest Florida — Pensacola, Florida, United States
• Emory University — Atlanta, Georgia, United States
• Northeast Georgia Heart Center, PC — Gainesville, Georgia, United States
• Northwestern University — Chicago, Illinois, United States
• Midwest Heart Foundation — Lombard, Illinois, United States
• Lutheran Hospital of Indiana and Northern Indiana Research Alliance of the Heart Center Medical Group — Fort Wayne, Indiana, United States
• The Care Group — Indianapolis, Indiana, United States
• Kentucky Heart Institute / King's Daughter — Ashland, Kentucky, United States
• Baptist Healthcare System Inc. (d/b/a Central Baptist Hospital) — Lexington, Kentucky, United States
• Johns Hopkins — Baltimore, Maryland, United States
• MedStar Research Institute (Washington Hospital Center) — Hyattsville, Maryland, United States
• The Brigham and Women's Hospital Inc. — Boston, Massachusetts, United States
• Caritas St. Elizabeth's Medical Center — Boston, Massachusetts, United States
• Henry Ford Health System — Detroit, Michigan, United States
• Alaska Regional Hospital and Alaska Cardiovascular Research Foundation, LLC — Anchorage, Alaska, United States

Full record on ClinicalTrials.gov

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