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

May 26, 2025 updated by: Dr. Derek Exner, University of Calgary

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, have abnormal test results from a 24 hour heart monitor, and who have low normal heart function.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Estimated)

700

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Leuven, Belgium
        • UZ Leuven - Campus Gasthuisberg
  • Canada
      • Laval, Canada, G1V 4G5
        • Quebec Heart Institute
    • Alberta
      • Calgary, Alberta, Canada, T2N 4Z6
        • Libin Cardiovascular Institute of Alberta
      • Edmonton, Alberta, Canada, T6G 2B7
        • University of Alberta Hospital
      • Edmonton, Alberta, Canada, T5H 3V9
        • Royal Alexandra Hospital
    • British Columbia
      • New Westminster, British Columbia, Canada, V3L 3W4
        • Fraser Clinical Trials
      • Vancouver, British Columbia, Canada, V5Z 1M9
        • Vancouver General Hospital
      • Vancouver, British Columbia, Canada, V6E 1M7
        • St. Paul's Hospital/Providence Health Care
      • Victoria, British Columbia, Canada, V8Z 0B9
        • Victoria Cardiac Arrhythmia Trials
    • Manitoba
      • Winnipeg, Manitoba, Canada, R2H 2A6
        • St. Boniface Hospital
      • Winnipeg, Manitoba, Canada, R3L 1Z5
        • Cardio 1
    • New Brunswick
      • St. John, New Brunswick, Canada, E2L 2L4
        • New Brunswick Heart Centre
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3H 3A7
        • Queen Elizabeth II Health Sciences Center
    • Ontario
      • Cambridge, Ontario, Canada, N1R 6V6
        • Cambridge Cardiac Care Centre
      • Hamilton, Ontario, Canada, L8L 2X2
        • Hamilton Health Sciences Centre
      • London, Ontario, Canada, N0L 1W0
        • University of Western Ontario
      • Newmarket, Ontario, Canada, L3Y 2P9
        • Southlake
      • Ottawa, Ontario, Canada, K1Y 4W7
        • Ottawa Heart Institute
      • Toronto, Ontario, Canada, M5B 1W8
        • St. Michael's Hospital
      • Toronto, Ontario, Canada, M5G 2C4
        • Toronto General Hospital
      • Toronto, Ontario, Canada, M4N 3N5
        • Sunnybrook Health Sciences Centre
    • Quebec
      • Montreal, Quebec, Canada, H3G 1A4
        • McGill University Health Centre
      • Montreal, Quebec, Canada, H1T 1C8
        • Montreal Heart Institute
      • Montreal, Quebec, Canada, H2W 1T8
        • CHUM
      • Sherbrooke, Quebec, Canada, J1H 5N4
        • Centre hospitalier universitaire de Sherbrooke (CHUS)
      • Trois-Rivieres, Quebec, Canada, G8Z 3R9
        • Centre Hospitalier Universitaire Regional de Trois-Rivieres (CHRTR)
    • Saskatchewan
      • Regina, Saskatchewan, Canada, S4P 0W5
        • Prairie Vascular Research Network
      • Saskatoon, Saskatchewan, Canada, S7N 0W8
        • Royal University Hospital
  • Finland
      • Helsinki, Finland
        • HUCH Helsinki University Central Hospital
      • Oulu, Finland
        • University of Oulu
  • France
      • Brest, France
        • CHRU Brest - Hôpital de la Cavale Blanche
      • Nantes, France
        • Hôpital Guillaume et René Laënnec - CHU de Nantes
      • Toulouse, France
        • Clinique Pasteur
  • Germany
      • Göttingen, Germany, 37099
        • Universitätsmedizin Göttingen Georg-August-Universität
  • Hungary
      • Zalaegerszeg, Hungary
        • Zala Megyei Kórház
  • Italy
      • Bergamo, Italy
        • Azienda Ospedaliera Papa Giovanni XXIII
      • Bologna, Italy
        • Policlinico Sant' Orsola - Malpighi
      • Pavia, Italy
        • Fondazione IRCCS Policlinico San Matteo
  • Norway
      • Oslo, Norway
        • Oslo Universitetssykehus Rikshospitalet
  • Saudi Arabia
      • Riyadh, Saudi Arabia
        • King Saud University
  • Slovakia
      • Bratislava, Slovakia
        • Slovak Medical University in Bratislava
  • South Africa
      • Centurion, South Africa
        • Unitas Hospital
  • Spain
      • Alicante, Spain, 03010
        • Hospital General Universitario de Alicante (HGUA)
      • Barcelona, Spain, 08036
        • Hospital Universitario Clínic de Barcelona
      • Madrid, Spain, 28046
        • Hospital Universitario La Paz
      • Madrid, Spain
        • Hospital Universitario 12 de Octubre
      • Madrid, Spain
        • Hospital Universitario La Paz
  • Sweden
      • Örebro, Sweden, 70185
        • Universitetssjukhuset Orebro
  • United Kingdom
      • Liverpool, United Kingdom
        • Liverpool Heart and Chest Hospital
      • Swindon, United Kingdom
        • Great Western Hospital NHS Trust
  • United States
    • Alabama
      • Huntsville, Alabama, United States, 35801
        • Heart Center Research LLC
    • Colorado
      • Lakewood, Colorado, United States, 80228
        • Colorado Heart and Vascular
    • Florida
      • Tampa, Florida, United States, 33612
        • James A Haley Veterans' Center
    • Indiana
      • Evansville, Indiana, United States, 47630
        • The Heart Group/Deaconess
    • Iowa
      • West Des Moines, Iowa, United States, 50266
        • Iowa Heart Center
    • Maryland
      • Salisbury, Maryland, United States, 21804
        • Delmarva Heart Foundation
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Beth Israel Deaconess
    • Michigan
      • Saint Louis, Michigan, United States, 63110
        • Washington University Medical School
      • Southfield, Michigan, United States, 48075
        • St. John Providence Hospital
    • Missouri
      • Springfield, Missouri, United States, 65807
        • Lester E Cox Medical Center
    • New Jersey
      • Ridgewood, New Jersey, United States, 07450
        • The Valley Hospital
      • Voorhees, New Jersey, United States, 08034
        • Associated Cardiovascular Consultants/Lourdes Cardiology Services
    • New York
      • New York, New York, United States, 10032
        • New York Presbyterian Hospital
      • New York, New York, United States, 10029
        • North Shore LIJ
    • Ohio
      • Akron, Ohio, United States, 44304
        • Northeast Ohio Cardiovascular Specialists
      • Cincinnati, Ohio, United States, 45242
        • Bethesda North Hospital
      • Cincinnati, Ohio, United States, 45219
        • The Lindner Research Center
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic
      • Columbus, Ohio, United States, 43210
        • The Ohio State University
    • Pennsylvania
      • Doylestown, Pennsylvania, United States, 18901
        • Doylestown Cardiology
      • Pittsburgh, Pennsylvania, United States, 15213
        • University of Pittsburgh Medical Center UPMC Presbyterian
      • Wilkes-Barre, Pennsylvania, United States, 18722
        • Geisinger Wyoming Valley Medical Center
    • South Carolina
      • Greenville, South Carolina, United States, 29605
        • Greenville Hospital System
    • Tennessee
      • Nashville, Tennessee, United States, 37232
        • Vanderbilt University Medical Center
      • Nashville, Tennessee, United States, 37203
        • St. Thomas Research Institute
    • Texas
      • Amarillo, Texas, United States, 79106
        • Amarillo Heart Group
    • Virginia
      • Charlottesville, Virginia, United States, 22908
        • University of Virginia
      • Lynchburg, Virginia, United States, 24510
        • Centra Medical Group
    • Washington
      • Spokane, Washington, United States, 99204
        • Heart Clinics Northwest

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 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 at least 40 days after a confirmed MI ≥ 3 months after coronary angioplasty or coronary bypass surgery and within the following time windows:

    • LVEF ≤ 7 months of screening visit if index MI was ≤ 1 year of enrolment
    • LVEF ≤ 13 months of screening visit if index MI was > 1 & < 3 years of enrolment
    • LVEF ≤ 25 months of screening visit if index MI was ≥ 3 years of enrolment
  • Proven, necessary or appropriate medications (e.g. beta-blocker, ACE inhibitor / ARB, statin, and anti-platelet)
  • In normal sinus rhythm (ECG documented) ≤ 8 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 at least 2 months after the index MI and the specified time after coronary revascularization
  • In normal sinus rhythm (ECG documented) within 8 weeks prior to the screening Holter
  • In normal sinus rhythm for ≥ 18 hours of the 24 hr screening Holter as determined by the study Holter Core Lab

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Mortality
Time Frame: Minimum of 18 months of follow-up (average follow-up of 5 years).
Minimum of 18 months of follow-up (average follow-up of 5 years).

Secondary Outcome Measures

Outcome Measure
Time Frame
Cardiac death
Time Frame: Average follow-up 5 years.
Average follow-up 5 years.
Arrhythmic death
Time Frame: Average follow-up 5 years.
Average follow-up 5 years.
Arrhythmic syncope
Time Frame: Average follow-up 5 years.
Average follow-up 5 years.
Appropriate ICD therapies
Time Frame: Average follow-up 5 years.
Average follow-up 5 years.
Quality of life
Time Frame: Average follow-up 5 years.
Average follow-up 5 years.
Inappropriate ICD therapies
Time Frame: Five years (average)
Five years (average)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Calgary

Collaborators

GE Healthcare
Canadian Institutes of Health Research (CIHR)
Medtronic
Cardiac Arrhythmia Network of Canada
Alberta Innovation and Science
Accelerating Clinical Trials Consortium

Investigators

  • Principal Investigator: Derek V Exner, MD, MPH, University Of Calgary

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 18, 2011

Primary Completion (Actual)

October 31, 2024

Study Completion (Actual)

October 31, 2024

Study Registration Dates

First Submitted

April 29, 2008

First Submitted That Met QC Criteria

May 1, 2008

First Posted (Estimated)

May 7, 2008

Study Record Updates

Last Update Posted (Actual)

May 30, 2025

Last Update Submitted That Met QC Criteria

May 26, 2025

Last Verified

May 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 21721

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

uncertain

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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