DEfibrillators To REduce Risk by MagnetIc ResoNance Imaging Evaluation

NCT00487279 | Terminated Results DMC

• 1 other identifier: Determine2007v12
• Study Type: interventional
• Target: 81
• Locations: 1 country
• Sites: 56

Brief Summary

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.

Conditions

Coronary Artery Disease; Left Ventricular Dysfunction; Sudden Cardiac Death

Keywords

Coronary; Artery; Disease; Sudden; Cardiac; Death; ICD

Outcome Measures

Primary Outcomes (1)

• All-cause Mortality

  Total survival will be evaluated 2 years after the last patient is randomized.

Secondary Outcomes (1)

• Arrhythmic Mortality

  Total survival will be evaluated 2 years after the last patient is randomized.

Study Arms (2)

ICD Group

EXPERIMENTAL

ICD (Implantable Cardioverter Defibrillator)

Device: Defibrillator

Control Group

OTHER

Medial Therapy

Other: Control

Interventions

Defibrillator DEVICE

ICD(Implantable Cardioverter Defibrillator)

Also known as: Implantable Cardioverter Defibrillator

ICD Group

Control OTHER

No Intervention

Also known as: No Intervention

Control Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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
• Evidence of CAD a with either a history of prior myocardial infarction OR any LV dysfunction

Sponsors & Collaborators

• Abbott Medical Devices: lead
• Northwestern University: collaborator

Study Sites (56)

Alaska Regional Hospital and Alaska Cardiovascular Research Foundation, LLC

Anchorage, Alaska, 99508, United States

Location

University of Arizona

Tucson, Arizona, 85724, United States

Location

Glendale Memorial Hospital and Health Center

Glendale, California, 91204, United States

Location

Long Beach Memorial Medical Center

Long Beach, California, 90806, United States

Location

Hollywood Presbyterian Medical Center

Los Angeles, California, 90027, United States

Location

UCLA Medical Center

Los Angeles, California, 90095, United States

Location

Hoag Memorial Hospital Presbyterian and Radin Inc.

Newport Beach, California, 92263, United States

Location

Catholic Healthcare West (d/b/a mercy General Hospital) and Regional Cardiology Associates

Sacramento, California, 95818, United States

Location

Rocky Mountain Cardiovascular Associates

Denver, Colorado, 80204, United States

Location

University of Florida-Shands/Jacksonville

Jacksonville, Florida, 32209, United States

Location

Orlando Regional Healthcare System

Orlando, Florida, 32806, United States

Location

Cardiology Consultants of Northwest Florida

Pensacola, Florida, 32501, United States

Location

Emory University

Atlanta, Georgia, 30365, United States

Location

Northeast Georgia Heart Center, PC

Gainesville, Georgia, 30501, United States

Location

Northwestern University

Chicago, Illinois, 60611, United States

Location

Midwest Heart Foundation

Lombard, Illinois, 60148, United States

Location

Lutheran Hospital of Indiana and Northern Indiana Research Alliance of the Heart Center Medical Group

Fort Wayne, Indiana, 46804, United States

Location

The Care Group

Indianapolis, Indiana, 46260, United States

Location

Kentucky Heart Institute / King's Daughter

Ashland, Kentucky, 41101, United States

Location

Baptist Healthcare System Inc. (d/b/a Central Baptist Hospital)

Lexington, Kentucky, 40503, United States

Location

Johns Hopkins

Baltimore, Maryland, 21287, United States

Location

MedStar Research Institute (Washington Hospital Center)

Hyattsville, Maryland, 20783, United States

Location

The Brigham and Women's Hospital Inc.

Boston, Massachusetts, 02115, United States

Location

Caritas St. Elizabeth's Medical Center

Boston, Massachusetts, 02135, United States

Location

Henry Ford Health System

Detroit, Michigan, 48202, United States

Location

Advanced Cardiac Healthcare (Bronson Methodist Hospital)

Kalamazoo, Michigan, 49007, United States

Location

William Beaumont Hospital

Royal Oak, Michigan, 48073, United States

Location

Minneapolis Heart Institute Foundation/Abbott NW Hospital

Minneapolis, Minnesota, 55407, United States

Location

Metropolitan Cardiology Consultants (MCC) / Allina Health System (Mercy & Unity Hospitals)

Minneapolis, Minnesota, 55433, United States

Location

University of Nebraska Medical Center

Omaha, Nebraska, 68198, United States

Location

Valley Hospital

Ridgewood, New Jersey, 07450, United States

Location

New York Methodist Hospital

Brooklyn, New York, 11215, United States

Location

St. Luke's - Roosevelt Hospital Center

New York, New York, 10019, United States

Location

Columbia University Medical Center

New York, New York, 10032, United States

Location

University of Rochester

Rochester, New York, 14642, United States

Location

St. Francis Hospital

Roslyn, New York, 11576, United States

Location

LeBauer Cardiovascular Research Foundation and Moses H. Cone Memorial Hospital

Greensboro, North Carolina, 27401, United States

Location

University of Maryland Baltimore and Maryland Medical Center

Cleveland, Ohio, 21201, United States

Location

University Hospitals of Cleveland

Cleveland, Ohio, 44106, United States

Location

MetroHealth Medical Center

Cleveland, Ohio, 44109, United States

Location

The Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Location

North Ohio Research, Ltd.

Elyria, Ohio, 44035, United States

Location

AHS Hillcrest Medical Center, LLC and Oklahoma Heart Institute

Tulsa, Oklahoma, 74104, United States

Location

Abington Memorial Hospital

Abington, Pennsylvania, 19001, United States

Location

Lehigh Valley Hospital and Health Network

Allentown, Pennsylvania, 18103, United States

Location

Allegheny-Singer Research Institute

Pittsburgh, Pennsylvania, 15212, United States

Location

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15213, United States

Location

Stern Cardiovascular Center

Germantown, Tennessee, 38138, United States

Location

Centennial Medical Center

Nashville, Tennessee, 37203, United States

Location

St. Thomas Research Institute, LLC

Nashville, Tennessee, 37205, United States

Location

Vanderbilt Medical Center

Nashville, Tennessee, 37212, United States

Location

Methodist Hospital Research Institute

Houston, Texas, 77030, United States

Location

St. Luke's Episcopal Hospital

Houston, Texas, 77030, United States

Location

Sentara Hospitals and Sentara Cardiovascular Research Institute

Norfolk, Virginia, 23507, United States

Location

Cardiovascular Associates Virginia Beach

Virginia Beach, Virginia, 23454, United States

Location

North Cascade Cardiology

Bellingham, Washington, 98225, United States

Location

MeSH Terms

Conditions

Coronary Artery Disease; Ventricular Dysfunction, Left; Death, Sudden, Cardiac; Disease; Death

Interventions

Defibrillators; Defibrillators, Implantable

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Ventricular Dysfunction; Heart Arrest; Death, Sudden; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Electrodes; Electrical Equipment and Supplies; Equipment and Supplies; Electrodes, Implanted; Prostheses and Implants

Results Point of Contact

• Title: Heidi Hinrichs/Sr. Director, Clinical Operations
• Organization: St. Jude Medical CRMD

hhinrichs@sjm.com

(818) 493-3297

Study Officials

• Alan Kadish, MD

  Northwestern University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 13, 2007
• First Posted: June 18, 2007
• Study Start: June 1, 2007
• Primary Completion: December 1, 2010
• Study Completion: April 1, 2011
• Last Updated: February 5, 2019
• Results First Posted: March 26, 2012

Record last verified: 2019-02

Locations

US (56)