DEfibrillators To REduce Risk by MagnetIc ResoNance Imaging Evaluation (DETERMINE)
Coronary Artery Disease, Left Ventricular Dysfunction, Sudden Cardiac Death
About this trial
This is an interventional treatment trial for Coronary Artery Disease focused on measuring Coronary, Artery, Disease, Sudden, Cardiac, Death, ICD
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria
- 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
- Spontaneous arrhythmia that precludes assessment by cardiac MRI
- 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
- 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
- Uninterpretable MRI images by core lab criteria
- Any condition other than cardiac disease that, in the investigator's judgment, would seriously limit life expectancy (poor 6-month survival)
- Marked valvular heart disease requiring surgical intervention
- Current alcohol or drug abuse
- Participating in other trials with an active treatment arm (not to exclude patients who are in trials of diagnostic techniques or approved therapies)
- Unwilling or unable to provide informed consent *Exception: Cardiac arrest or spontaneous VT that occurs during the acute MI event will not be considered an exclusion
Sites / Locations
- Alaska Regional Hospital and Alaska Cardiovascular Research Foundation, LLC
- University of Arizona
- Glendale Memorial Hospital and Health Center
- Long Beach Memorial Medical Center
- Hollywood Presbyterian Medical Center
- UCLA Medical Center
- Hoag Memorial Hospital Presbyterian and Radin Inc.
- Catholic Healthcare West (d/b/a mercy General Hospital) and Regional Cardiology Associates
- Rocky Mountain Cardiovascular Associates
- University of Florida-Shands/Jacksonville
- Orlando Regional Healthcare System
- Cardiology Consultants of Northwest Florida
- Emory University
- Northeast Georgia Heart Center, PC
- Northwestern University
- Midwest Heart Foundation
- Lutheran Hospital of Indiana and Northern Indiana Research Alliance of the Heart Center Medical Group
- The Care Group
- Kentucky Heart Institute / King's Daughter
- Baptist Healthcare System Inc. (d/b/a Central Baptist Hospital)
- Johns Hopkins
- MedStar Research Institute (Washington Hospital Center)
- The Brigham and Women's Hospital Inc.
- Caritas St. Elizabeth's Medical Center
- Henry Ford Health System
- Advanced Cardiac Healthcare (Bronson Methodist Hospital)
- William Beaumont Hospital
- Minneapolis Heart Institute Foundation/Abbott NW Hospital
- Metropolitan Cardiology Consultants (MCC) / Allina Health System (Mercy & Unity Hospitals)
- University of Nebraska Medical Center
- Valley Hospital
- New York Methodist Hospital
- St. Luke's - Roosevelt Hospital Center
- Columbia University Medical Center
- University of Rochester
- St. Francis Hospital
- LeBauer Cardiovascular Research Foundation and Moses H. Cone Memorial Hospital
- University of Maryland Baltimore and Maryland Medical Center
- University Hospitals of Cleveland
- MetroHealth Medical Center
- The Cleveland Clinic Foundation
- North Ohio Research, Ltd.
- AHS Hillcrest Medical Center, LLC and Oklahoma Heart Institute
- Abington Memorial Hospital
- Lehigh Valley Hospital and Health Network
- Allegheny-Singer Research Institute
- University of Pittsburgh Medical Center
- Stern Cardiovascular Center
- Centennial Medical Center
- St. Thomas Research Institute, LLC
- Vanderbilt Medical Center
- Methodist Hospital Research Institute
- St. Luke's Episcopal Hospital
- Sentara Hospitals and Sentara Cardiovascular Research Institute
- Cardiovascular Associates Virginia Beach
- North Cascade Cardiology
Arms of the Study
Arm 1
Arm 2
Experimental
Other
ICD Group
Control Group
ICD (Implantable Cardioverter Defibrillator)
Medial Therapy