Clincosm LogoSign in Get a demo

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

Sponsor
University of Calgary (Other)
Overall Status
Unknown status
CT.gov ID
NCT00673842
Collaborator
Canadian Institutes of Health Research (CIHR) (Other), Alberta Innovation and Science (Other), Medtronic (Industry), GE Healthcare (Industry)
1,000
Enrollment
94
Locations
2
Arms
129.1
Duration (Months)
10.6
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

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
  • 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

Study Type:
Interventional
Anticipated 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 :
Mar 1, 2011
Anticipated Primary Completion Date :
Jan 1, 2019
Anticipated Study Completion Date :
Dec 1, 2021

Arms and Interventions

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 Names:
  • Standard medical therapy alone

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Mortality [Minimum of 18 months of follow-up (average follow-up of 5 years).]

    Secondary Outcome Measures

    1. Cardiac death [Average follow-up 5 years.]

    2. Arrhythmic death [Average follow-up 5 years.]

    3. Arrhythmic syncope [Average follow-up 5 years.]

    4. Appropriate ICD therapies [Average follow-up 5 years.]

    5. Quality of life [Average follow-up 5 years.]

    6. Inappropriate ICD therapies [Five years (average)]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No

    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

    Locations

    Site City State Country Postal Code
    1 Heart Center Research LLC Huntsville Alabama United States 35801
    2 Heart Center Research LLC Huntsville Alabama United States 35801
    3 Cardiovascular Consultants Heart Center Fresno California United States 93720
    4 Colorado Heart and Vascular Lakewood Colorado United States 80228
    5 Hartford Hospital Hartford Connecticut United States 06106
    6 Yale University New Haven Connecticut United States 06519
    7 Watson Clinic Lakeland Florida United States 33805
    8 James A Haley Veterans' Center Tampa Florida United States 33612
    9 The Heart Group/Deaconess Evansville Indiana United States 47630
    10 Iowa Heart Center West Des Moines Iowa United States 50266
    11 Delmarva Heart Foundation Salisbury Maryland United States 21804
    12 Beth Israel Deaconess Boston Massachusetts United States 02215
    13 Washington University Medical School Saint Louis Michigan United States 63110
    14 St. John Providence Hospital Southfield Michigan United States 48075
    15 Lester E Cox Medical Center Springfield Missouri United States 65807
    16 The Valley Hospital Ridgewood New Jersey United States 07450
    17 Associated Cardiovascular Consultants/Lourdes Cardiology Services Voorhees New Jersey United States 08034
    18 North Shore LIJ New York New York United States 10029
    19 New York Presbyterian Hospital New York New York United States 10032
    20 Carolinas Medical Center Charlotte North Carolina United States 28203
    21 Northeast Ohio Cardiovascular Specialists Akron Ohio United States 44304
    22 The Lindner Research Center Cincinnati Ohio United States 45219
    23 Bethesda North Hospital Cincinnati Ohio United States 45242
    24 Cleveland Clinic Cleveland Ohio United States 44195
    25 The Ohio State University Columbus Ohio United States 43210
    26 Doylestown Cardiology Doylestown Pennsylvania United States 18901
    27 Hamot Medical Center Erie Pennsylvania United States 16550
    28 University of Pennsylvania Philadelphia Pennsylvania United States 19104
    29 University of Pittsburgh Medical Center UPMC Presbyterian Pittsburgh Pennsylvania United States 15213
    30 Geisinger Wyoming Valley Medical Center Wilkes-Barre Pennsylvania United States 18722
    31 South Carolina Heart Center Columbia South Carolina United States 29204
    32 Pee Dee Cardiology Florence South Carolina United States 29506
    33 Greenville Hospital System Greenville South Carolina United States 29605
    34 Spartanburg Regional Healthcare System Spartanburg South Carolina United States 29303
    35 St. Thomas Research Institute Nashville Tennessee United States 37203
    36 Vanderbilt University Medical Center Nashville Tennessee United States 37232
    37 Amarillo Heart Group Amarillo Texas United States 79106
    38 Scott & White Healthcare Temple Texas United States 76508
    39 University of Virginia Charlottesville Virginia United States 22908
    40 Centra Medical Group Lynchburg Virginia United States 24510
    41 Heart Clinics Northwest Spokane Washington United States 99204
    42 Wheaton Franciscan Healthcare Milwaukee Wisconsin United States 53210
    43 Aurora St. Luke's Medical Center/Aurora Cardiovascular Services Milwaukee Wisconsin United States 53215
    44 UZ Leuven - Campus Gasthuisberg Leuven Belgium
    45 Libin Cardiovascular Institute of Alberta Calgary Alberta Canada T2N 4Z6
    46 Royal Alexandra Hospital Edmonton Alberta Canada T5H 3V9
    47 University of Alberta Hospital Edmonton Alberta Canada T6G 2B7
    48 Fraser Clinical Trials New Westminster British Columbia Canada V3L 3W4
    49 Vancouver General Hospital Vancouver British Columbia Canada V5Z 1M9
    50 St. Paul's Hospital/Providence Health Care Vancouver British Columbia Canada V6E 1M7
    51 Victoria Cardiac Arrhythmia Trials Victoria British Columbia Canada V8R 4R2
    52 St. Boniface Hospital Winnipeg Manitoba Canada R2H 2A6
    53 New Brunswick Heart Centre St. John New Brunswick Canada E2L 2L4
    54 Memorial University of Newfoundland St Johns Newfoundland and Labrador Canada A1B 3V6
    55 Queen Elizabeth II Health Sciences Center Halifax Nova Scotia Canada B3H 3A7
    56 Hamilton Health Sciences Centre Hamilton Ontario Canada L8L 2X2
    57 Hamilton Health Sciences II Hamilton Ontario Canada L8L 2X2
    58 University of Western Ontario London Ontario Canada N0L 1W0
    59 Southlake Newmarket Ontario Canada L3Y 2P9
    60 Ottawa Heart Institute Ottawa Ontario Canada K1Y 4W7
    61 Sunnybrook Health Sciences Centre Toronto Ontario Canada M4N 3N5
    62 St. Michael's Hospital Toronto Ontario Canada M5B 1W8
    63 Toronto General Hospital Toronto Ontario Canada M5G 2C4
    64 Montreal Heart Institute Montreal Quebec Canada H1T 1C8
    65 CHUM Montreal Quebec Canada H2W 1T8
    66 McGill University Health Centre Montreal Quebec Canada H3G 1A4
    67 Centre Hospitalier Universitaire de Sherbrooke (CHUS) Sherbrooke Quebec Canada J1H 5N4
    68 Centre Hospitalier Universitaire Regional de Trois-Rivieres (CHRTR) Trois-Rivieres Quebec Canada G8Z 3R9
    69 Prairie Vascular Research Network Regina Saskatchewan Canada S4P 0W5
    70 Royal University Hospital Saskatoon Saskatchewan Canada S7N 0W8
    71 Quebec Heart Institute Laval Canada G1V 4G5
    72 HUCH Helsinki University Central Hospital Helsinki Finland
    73 University of Oulu Oulu Finland
    74 CHRU Brest - Hôpital de la Cavale Blanche Brest France
    75 Hôpital Guillaume et René Laënnec - CHU de Nantes Nantes France 44093
    76 Hôpital Guillaume et René Laënnec - CHU de Nantes Nantes France
    77 Clinique Pasteur Toulouse France
    78 Universitätsmedizin Göttingen Georg-August-Universität Göttingen Germany 37099
    79 Zala Megyei Kórház Zalaegerszeg Hungary
    80 Azienda Ospedaliera Papa Giovanni XXIII Bergamo Italy
    81 Policlinico Sant' Orsola - Malpighi Bologna Italy
    82 Fondazione IRCCS Policlinico San Matteo Pavia Italy
    83 Oslo Universitetssykehus Rikshospitalet Oslo Norway
    84 King Saud University Riyadh Saudi Arabia
    85 Slovak Medical University in Bratislava Bratislava Slovakia
    86 Unitas Hospital Centurion South Africa
    87 Hospital General Universitario de Alicante (HGUA) Alicante Spain 03010
    88 Hospital Universitario Clinic de Barcelona Barcelona Spain 08036
    89 Hospital Universitario La Paz Madrid Spain 28046
    90 Hospital Universitario 12 de Octubre Madrid Spain
    91 Hospital Universitario La Paz Madrid Spain
    92 Universitetssjukhuset Örebro Örebro Sweden 70185
    93 Liverpool Heart and Chest Hospital Liverpool United Kingdom
    94 Great Western Hospital NHS Trust Swindon United Kingdom

    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

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    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
    Last Update Posted:
    Jul 11, 2016
    Last Verified:
    Jul 1, 2016
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Keywords provided by Dr. Derek Exner, Professor and Canada Research Chair in Cardiovascular Clinical Trials, University of Calgary
    Noninvasive assessment
    Holter
    Additional relevant MeSH terms:
    Myocardial Infarction
    Infarction
    Death, Sudden

    Study Results

    No Results Posted as of Jul 11, 2016