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Efficacy of Implantable Defibrillator Therapy After a Myocardial Infarction (REFINE-ICD)

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ClinicalTrials.gov Identifier: NCT00673842
Recruitment Status : Recruiting
First Posted : May 7, 2008
Last Update Posted : July 11, 2016
Canadian Institutes of Health Research (CIHR)
Alberta Innovation and Science
GE Healthcare
Information provided by (Responsible Party):
Dr. Derek Exner, University of Calgary

Brief Summary:
This study will assess whether an implantable defibrillator will increase the likelihood of survival in patients who have had a heart attack in the prior 5 years, have abnormal test results from a 24 hour heart monitor, and who have low normal heart function.

Condition or disease Intervention/treatment Phase
Myocardial Infarction Sudden Death Device: Implantable Cardioverter Defibrillator + Usual Care Other: Usual care Phase 3

Detailed Description:
The REFINE ICD trial will assess whether prophylactic ICD therapy, guided by non-invasive risk assessment tools, reduces mortality in MI survivors with better-preserved LV function.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Risk Estimation Following Infarction Noninvasive Evaluation - ICD Efficacy
Study Start Date : March 2011
Estimated Primary Completion Date : January 2019
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Implantable Cardioverter Defibrillator + Usual Care
Medtronic ICD
Device: Implantable Cardioverter Defibrillator + Usual Care
Any Medtronic approved (in each geography) single chamber or dual chamber implantable cardioverter defibrillator (ICD)
Other Names:
  • Implantable Cardioverter Defibrillator
  • ICD
Active Comparator: Usual Care
Usual post-MI care
Other: Usual care
Usual post-MI care
Other Name: Standard medical therapy alone

Primary Outcome Measures :
  1. Mortality [ Time Frame: Minimum of 18 months of follow-up (average follow-up of 5 years). ]

Secondary Outcome Measures :
  1. Cardiac death [ Time Frame: Average follow-up 5 years. ]
  2. Arrhythmic death [ Time Frame: Average follow-up 5 years. ]
  3. Arrhythmic syncope [ Time Frame: Average follow-up 5 years. ]
  4. Appropriate ICD therapies [ Time Frame: Average follow-up 5 years. ]
  5. Quality of life [ Time Frame: Average follow-up 5 years. ]
  6. Inappropriate ICD therapies [ Time Frame: Five years (average) ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Site investigators are responsible for screening. Subjects must meet all inclusion criteria. Subjects with any exclusion criteria will be excluded.

Initial inclusion criteria (eligibility for Holter screening).

  • 18 - 80 years old at time of consent
  • History of MI > / = 2 and < / = 60 months prior to screening based on ESC/ACCF/AHA/WHF criteria (both STEMI and NSTEMI subjects are eligible)
  • Appropriate post-MI management including revascularization where indicated
  • No contra-indication for transvenous ICD placement (e.g., mechanical tricuspid valve, known vascular access problems, active sepsis, etc.)
  • LVEF 36% - 50% measured 2 to 60 months after a confirmed MI, > / = 3 months after coronary angioplasty or coronary bypass surgery and < / = 6 months of the screening visit
  • Proven, necessary or appropriate medications (e.g. beta-blocker, ACE inhibitor / ARB, statin, and anti-platelet)
  • In normal sinus rhythm (ECG documented) within the two weeks prior to the screening Holter
  • Written informed consent
  • Able and willing to complete the screening Holter, including the six-minute hall walk

Additional inclusion criterion (eligibility for randomization).

• Abnormal HRT & TWA (core lab interpretation) on Holter performed 2 to 60 months after the index MI and the specified time after coronary revascularization

Exclusion criteria (randomization or registry).

  • Use of antiarrhythmic drugs
  • Clinical indication for permanent pacemaker or a cardiac resynchronization device
  • Clinical indication for an ICD or cardiac resynchronization ICD
  • Prior implantation of a pacemaker, ICD, or Cardiac Resynchronization device
  • Any condition, in the investigator's judgment, that would limit life expectancy to < 12 months
  • Chronic renal failure (hemodialysis or peritoneal dialysis)
  • Active ischemia that is amenable to revascularization if not previously revascularized
  • Participation in another trial that may interfere with the REFINE ICD results.
  • Pregnancy
  • Inability to comply with the follow-up schedule

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00673842

Contact: Derek V Exner, MD, MPH 403-220-3219 exner@ucalgary.ca
Contact: Caroline (Liong Eng) Tan-Mesiatowsky, MD 403-210-7396 letanmes@ucalgary.ca

  Show 94 Study Locations
Sponsors and Collaborators
University of Calgary
Canadian Institutes of Health Research (CIHR)
Alberta Innovation and Science
GE Healthcare
Principal Investigator: Derek V Exner, MD, MPH University of Calgary

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dr. Derek Exner, Professor and Canada Research Chair in Cardiovascular Clinical Trials, University of Calgary
ClinicalTrials.gov Identifier: NCT00673842     History of Changes
Other Study ID Numbers: 21721
First Posted: May 7, 2008    Key Record Dates
Last Update Posted: July 11, 2016
Last Verified: July 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: uncertain

Keywords provided by Dr. Derek Exner, University of Calgary:
Noninvasive assessment

Additional relevant MeSH terms:
Myocardial Infarction
Death, Sudden
Pathologic Processes
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases