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Defibrillators To Reduce Risk by Magnetic ResoNance Imaging Evaluation

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Trial Conditions
  • Coronary Artery Disease
  • Left Ventricular Dysfunction
  • Sudden Cardiac Death
What is the purpose of this trial?

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.

Date & Status

Terminated

Who can Participate?

Eligibility

Ages:
18 and older

Gender:
Both

Eligibility

Inclusion Criteria:

Randomized Arm

1. Evidence of Coronary Artery Disease (CAD)a.

2. 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%

3. 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).

4. 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.

5. Patients aged 18 years or above

1. 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.

2. 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

1. History of cardiac arrest or spontaneous or inducible sustained VT (15 beats or more
at a rate of 120 BPM or greater)*

2. Unexplained syncope

3. Need for revascularization based on investigator's clinical assessment within the
next 12 months (patients may be reevaluated 90 days after revascularization)

4. Currently implanted permanent pacemaker and/or pacemaker/ICD lead

5. Contraindication to a ICD implant (i.e. inadequate venous access, bleeding disorder)

6. Acute or chronic severe renal insufficiency (< 30mL/min/1.73m2); acute renal
insufficiency of any severity due to hepato-renal syndrome

7. Current or planned renal or liver transplant

8. End stage renal disease on hemodialysis or peritoneal dialysis

9. Contraindication to CE-MRI or history of allergy to gadolinium-based contrast dye

10. 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

11. Recent MI (<40 days) or revascularization (<90 days)

12. CVA within 90 days

13. Antiarrhythmic drug therapy for ventricular arrhythmias

14. 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

Gender: Both
Steward Physician(s)
  • Alan Kadish, MD
Facilities
  • St. Elizabeth's Medical Center - Terminated
Trial Interventions
Device
  • Defibrillator
Other
  • Control
Physician Researcher

Investigator Name:

  • Alan Kadish, MD

Other Information

Sponsor: St. Jude Medical
Phase: N/A
Trial ID: NCT00487279
Volunteers:  Not Accepting Healthy Volunteers

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