DEfibrillators To REduce Risk by MagnetIc ResoNance Imaging Evaluation (DETERMINE)

This study has been terminated.
(Study terminated early due to inability to enroll.)
Sponsor:
Collaborator:
Northwestern University
Information provided by (Responsible Party):
St. Jude Medical
ClinicalTrials.gov Identifier:
NCT00487279
First received: June 13, 2007
Last updated: March 25, 2012
Last verified: March 2012
  Purpose

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.


Condition Intervention
Coronary Artery Disease
Left Ventricular Dysfunction
Sudden Cardiac Death
Device: Defibrillator
Other: Control

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: DEfibrillators To REduce Risk by MagnetIc ResoNance Imaging Evaluation

Resource links provided by NLM:


Further study details as provided by St. Jude Medical:

Primary Outcome Measures:
  • All-cause Mortality [ Time Frame: Total survival will be evaluated 2 years after the last patient is randomized. ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Arrhythmic Mortality [ Time Frame: Total survival will be evaluated 2 years after the last patient is randomized. ] [ Designated as safety issue: Yes ]
    Arrhythmic mortality was reported as the number of randomized patients who died due to arrhythmic death. Arrhythmic death was defined as death due to arrhythmia or sudden death.


Enrollment: 81
Study Start Date: June 2007
Study Completion Date: April 2011
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ICD Group
ICD (Implantable Cardioverter Defibrillator)
Device: Defibrillator
ICD(Implantable Cardioverter Defibrillator)
Other Name: Implantable Cardioverter Defibrillator
Control Group
Medial Therapy
Other: Control
No Intervention
Other Name: No Intervention

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00487279

  Show 56 Study Locations
Sponsors and Collaborators
St. Jude Medical
Northwestern University
Investigators
Principal Investigator: Alan Kadish, MD Northwestern University
  More Information

No publications provided

Responsible Party: St. Jude Medical
ClinicalTrials.gov Identifier: NCT00487279     History of Changes
Other Study ID Numbers: Determine2007v12
Study First Received: June 13, 2007
Results First Received: January 4, 2012
Last Updated: March 25, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by St. Jude Medical:
Coronary
Artery
Disease
Sudden
Cardiac
Death
ICD

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Death
Death, Sudden, Cardiac
Ventricular Dysfunction, Left
Ventricular Dysfunction
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Pathologic Processes
Heart Arrest
Death, Sudden

ClinicalTrials.gov processed this record on August 28, 2014