Efficacy of Implantable Defibrillator Therapy After a Myocardial Infarction (REFINE-ICD)
This study is currently recruiting participants.
Verified January 2012 by University of Calgary
Sponsor:
University of Calgary
Collaborators:
Alberta Innovation and Science
Medtronic
GE Healthcare
Information provided by (Responsible Party):
Dr. Derek Exner, University of Calgary
ClinicalTrials.gov Identifier:
NCT00673842
First received: April 29, 2008
Last updated: January 23, 2012
Last verified: January 2012
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Purpose
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 year, have abnormal test results from a 24 hour heart monitor, and who have low normal heart function.
| Condition | Intervention | Phase |
|---|---|---|
|
Myocardial Infarction Sudden Death |
Device: Implantable Cardioverter Defibrillator (Virtuoso models D154AWG, D164AWG, D154VWC, D164AWC, and moving forward) Other: Usual care |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Risk Estimation Following Infarction Noninvasive Evaluation - ICD Efficacy |
Resource links provided by NLM:
Further study details as provided by University of Calgary:
Primary Outcome Measures:
- Mortality [ Time Frame: Average follow-up of 5 years. ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Cardiac death [ Time Frame: Average follow-up 5 years. ] [ Designated as safety issue: No ]
- Arrhythmic death [ Time Frame: Average follow-up 5 years. ] [ Designated as safety issue: No ]
- Arrhythmic syncope [ Time Frame: Average follow-up 5 years. ] [ Designated as safety issue: Yes ]
- Appropriate ICD therapies [ Time Frame: Average follow-up 5 years. ] [ Designated as safety issue: No ]
- Quality of life [ Time Frame: Average follow-up 5 years. ] [ Designated as safety issue: No ]
- Cost-effectiveness [ Time Frame: Average follow-up 5 years. ] [ Designated as safety issue: No ]
- Single Nucleotide Polymorphism (SNP) profile [ Time Frame: Entire study duration. ] [ Designated as safety issue: No ]
- Deceleration capacity [ Time Frame: Entire study duration. ] [ Designated as safety issue: No ]
- Inappropriate ICD therapies [ Time Frame: Five years (average) ] [ Designated as safety issue: No ]
- System-related complications [ Time Frame: Five years (average) ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 1400 |
| Study Start Date: | March 2011 |
| Estimated Study Completion Date: | February 2018 |
| Estimated Primary Completion Date: | December 2017 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: A
Medtronic implantable defibrillator
|
Device: Implantable Cardioverter Defibrillator (Virtuoso models D154AWG, D164AWG, D154VWC, D164AWC, and moving forward)
Implantable Cardioverter Defibrillator (Medtronic Virtuoso models D154AWG, D164AWG, D154VWC, D164AWC, and newer models moving forward as they are approved for use in the participating regions / countries).
Other Names:
|
|
Active Comparator: Usual care
Usual post-MI care
|
Other: Usual care
Usual post-MI care
Other Name: Standard medical therapy alone
|
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.
Eligibility| Ages Eligible for Study: | 18 Years to 80 Years |
| Genders Eligible for Study: | Both |
| 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 < / = 14 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% - 49% measured 2 to 12 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 - 14 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00673842
Contacts
| Contact: Derek V Exner, MD, MPH | 403-220-3219 | exner@ucalgary.ca |
| Contact: Thiago Oliveira, MD | 403-210-7396 | toliveir@ucalgary.ca |
Locations
| Canada, Alberta | |
| Libin Cardiovascular Institute of Alberta | Recruiting |
| Calgary, Alberta, Canada, T2N 4Z6 | |
| Contact: Margaret Morck, RN mmorck@ucalgary.ca | |
| Principal Investigator: Katherine M Kavanagh, MD | |
| Canada, British Columbia | |
| Victoria Cardiac Arrhythmia Trials | Recruiting |
| Victoria, British Columbia, Canada, V8R 4R2 | |
| Contact: Deborah Parfett, RN dparfett@catrials.org | |
| Principal Investigator: Anthony Tang, MD | |
| Canada, Ontario | |
| University of Western Ontario | Recruiting |
| London, Ontario, Canada, N0L 1W0 | |
| Contact: Denise Hulley, RN Denise.hulley@lhsc.on.ca | |
| Contact: , RN | |
| Principal Investigator: Raymond Yee, MD | |
| Southlake | Recruiting |
| Newmarket, Ontario, Canada, L3Y 2P9 | |
| Contact: Kellie Winger, RN kwinger@southlakeregional.org | |
| Principal Investigator: Yaariv Khaykin, MD | |
| Canada, Quebec | |
| CHUM | Recruiting |
| Montreal, Quebec, Canada, H2W 1T8 | |
| Contact: Martine Bergeron martine.bergeron@crchum.qc.ca | |
| Principal Investigator: Benoit Coutu, MD | |
| Montreal Heart Institute | Recruiting |
| Montreal, Quebec, Canada, H1T 1C8 | |
| Contact: Francois Lemarbre, RN francois.lemarbre@icm-mhi.org | |
| Principal Investigator: Mario Talajic, MD | |
| Canada | |
| Quebec Heart Institute | Recruiting |
| Laval, Canada, G1V 4G5 | |
| Contact: Lyne Charbonneau lyne.charbonneau@criucpq.ulaval.ca | |
| Principal Investigator: Francois Philippon, MD | |
Sponsors and Collaborators
University of Calgary
Alberta Innovation and Science
Medtronic
GE Healthcare
Investigators
| Principal Investigator: | Derek V Exner, MD, MPH | University of Calgary |
More Information
No publications provided
| 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 |
| Study First Received: | April 29, 2008 |
| Last Updated: | January 23, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by University of Calgary:
|
Noninvasive assessment Holter |
Additional relevant MeSH terms:
|
Death, Sudden Infarction Myocardial Infarction Death Pathologic Processes Ischemia |
Necrosis Myocardial Ischemia Heart Diseases Cardiovascular Diseases Vascular Diseases |
ClinicalTrials.gov processed this record on May 16, 2013