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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
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

April 29, 2008
May 7, 2008
July 11, 2016
March 2011
January 2019   (Final data collection date for primary outcome measure)
Mortality [ Time Frame: Minimum of 18 months of follow-up (average follow-up of 5 years). ]
Not Provided
Complete list of historical versions of study NCT00673842 on ClinicalTrials.gov Archive Site
  • Cardiac death [ Time Frame: Average follow-up 5 years. ]
  • Arrhythmic death [ Time Frame: Average follow-up 5 years. ]
  • Arrhythmic syncope [ Time Frame: Average follow-up 5 years. ]
  • Appropriate ICD therapies [ Time Frame: Average follow-up 5 years. ]
  • Quality of life [ Time Frame: Average follow-up 5 years. ]
  • Inappropriate ICD therapies [ Time Frame: Five years (average) ]
Not Provided
Not Provided
Not Provided
 
Efficacy of Implantable Defibrillator Therapy After a Myocardial Infarction
Risk Estimation Following Infarction Noninvasive Evaluation - ICD Efficacy
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.
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.
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Myocardial Infarction
  • Sudden Death
  • 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
  • Other: Usual care
    Usual post-MI care
    Other Name: Standard medical therapy alone
  • Experimental: Implantable Cardioverter Defibrillator + Usual Care
    Medtronic ICD
    Intervention: Device: Implantable Cardioverter Defibrillator + Usual Care
  • Active Comparator: Usual Care
    Usual post-MI care
    Intervention: Other: Usual care
Perkiömäki J, Exner DV, Piira OP, Kavanagh K, Lepojärvi S, Talajic M, Karvonen J, Philippon F, Junttila J, Coutu B, Huikuri H. Heart Rate Turbulence and T-Wave Alternans in Patients with Coronary Artery Disease: The Influence of Diabetes. Ann Noninvasive Electrocardiol. 2015 Sep;20(5):481-7. doi: 10.1111/anec.12244. Epub 2015 Jan 15.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
1000
Not Provided
December 2021
January 2019   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 80 Years   (Adult, Older Adult)
No
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
Belgium,   Canada,   Finland,   France,   Germany,   Hungary,   Italy,   Norway,   Saudi Arabia,   Slovakia,   South Africa,   Spain,   Sweden,   United Kingdom,   United States
 
 
NCT00673842
21721
Yes
Not Provided
Plan to Share IPD: Undecided
Plan Description: uncertain
Dr. Derek Exner, University of Calgary
University of Calgary
  • Canadian Institutes of Health Research (CIHR)
  • Alberta Innovation and Science
  • Medtronic
  • GE Healthcare
Principal Investigator: Derek V Exner, MD, MPH University of Calgary
University of Calgary
July 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP