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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by University of Calgary
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
ClinicalTrials.gov Identifier:
NCT00673842
First received: April 29, 2008
Last updated: July 29, 2014
Last verified: July 2014
  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
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: December 2019
Estimated Primary Completion Date: December 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ICD Therapy in addition to Usual Care
Medtronic implantable defibrillator
Device: Implantable Cardioverter Defibrillator
Any Medtronic approved (in each geography) single chamber or dual chamber implantable cardioverter defibrillator (ICD)
Other Name: ICD
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 < / = 15 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 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
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: NCT00673842

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

  Show 72 Study Locations
Sponsors and Collaborators
University of Calgary
Canadian Institutes of Health Research (CIHR)
Alberta Innovation and Science
Medtronic
GE Healthcare
Investigators
Principal Investigator: Derek V Exner, MD, MPH University of Calgary
  More Information

Additional 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: July 29, 2014
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 July 31, 2014