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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00673842
Recruitment Status : Unknown
Verified July 2016 by Dr. Derek Exner, University of Calgary.
Recruitment status was:  Recruiting
First Posted : May 7, 2008
Last Update Posted : July 11, 2016
Sponsor:
Collaborators:
Canadian Institutes of Health Research (CIHR)
Alberta Innovation and Science
Medtronic
GE Healthcare
Information provided by (Responsible Party):
Dr. Derek Exner, University of Calgary

Study Description
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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 Design
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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


Arms and Interventions
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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


Outcome Measures
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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) ]

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

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
Contacts and Locations
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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


Contacts
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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

Locations
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Sponsors and Collaborators
University of Calgary
Canadian Institutes of Health Research (CIHR)
Alberta Innovation and Science
Medtronic
GE Healthcare
Investigators
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Principal Investigator: Derek V Exner, MD, MPH University of Calgary
More Information
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Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Dr. Derek Exner, Professor and Canada Research Chair in Cardiovascular Clinical Trials, University of Calgary
ClinicalTrials.gov Identifier: NCT00673842    
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
Holter
Additional relevant MeSH terms:
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Myocardial Infarction
Infarction
Death, Sudden
Ischemia
Pathologic Processes
Necrosis
 Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Death