Clinical trial NCT00673842: Efficacy of Implantable Defibrillator Therapy After a Myocardial Infarction
Official title: Risk Estimation Following Infarction Noninvasive Evaluation - ICD Efficacy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Myocardial Infarction
Sudden Death
Keywords: Noninvasive assessment
Holter
Lead sponsor: University of Calgary
Sponsor class: OTHER
Collaborators: name: Canadian Institutes of Health Research (CIHR)
name: Alberta Innovation and Science
name: Medtronic
name: GE Healthcare
name: Cardiac Arrhythmia Network of Canada
name: Accelerating Clinical Trials Consortium
First posted: 2008-05-07
Enrollment: 700
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

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 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 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

Primary outcomes:
measure: Mortality
timeFrame: Minimum of 18 months of follow-up (average follow-up of 5 years).
Secondary outcomes:
measure: Cardiac death
timeFrame: Average follow-up 5 years.
measure: Arrhythmic death
timeFrame: Average follow-up 5 years.
measure: Arrhythmic syncope
timeFrame: Average follow-up 5 years.
measure: Appropriate ICD therapies
timeFrame: Average follow-up 5 years.
measure: Quality of life
timeFrame: Average follow-up 5 years.
measure: Inappropriate ICD therapies
timeFrame: Five years (average)
Other outcomes:
Locations:
city: Huntsville
country: United States
facility: Heart Center Research LLC
state: Alabama
city: Lakewood
country: United States
facility: Colorado Heart and Vascular
state: Colorado
city: Tampa
country: United States
facility: James A Haley Veterans' Center
state: Florida
city: Evansville
country: United States
facility: The Heart Group/Deaconess
state: Indiana
city: West Des Moines
country: United States
facility: Iowa Heart Center
state: Iowa
city: Salisbury
country: United States
facility: Delmarva Heart Foundation
state: Maryland
city: Boston
country: United States
facility: Beth Israel Deaconess
state: Massachusetts
city: Saint Louis
country: United States
facility: Washington University Medical School
state: Michigan
city: Southfield
country: United States
facility: St. John Providence Hospital
state: Michigan
city: Springfield
country: United States
facility: Lester E Cox Medical Center
state: Missouri
city: Ridgewood
country: United States
facility: The Valley Hospital
state: New Jersey
city: Voorhees
country: United States
facility: Associated Cardiovascular Consultants/Lourdes Cardiology Services
state: New Jersey
city: New York
country: United States
facility: North Shore LIJ
state: New York
city: New York
country: United States
facility: New York Presbyterian Hospital
state: New York
city: Akron
country: United States
facility: Northeast Ohio Cardiovascular Specialists
state: Ohio
city: Cincinnati
country: United States
facility: The Lindner Research Center
state: Ohio
city: Cincinnati
country: United States
facility: Bethesda North Hospital
state: Ohio
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Columbus
country: United States
facility: The Ohio State University
state: Ohio
city: Doylestown
country: United States
facility: Doylestown Cardiology
state: Pennsylvania
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center UPMC Presbyterian
state: Pennsylvania
city: Wilkes-Barre
country: United States
facility: Geisinger Wyoming Valley Medical Center
state: Pennsylvania
city: Greenville
country: United States
facility: Greenville Hospital System
state: South Carolina
city: Nashville
country: United States
facility: St. Thomas Research Institute
state: Tennessee
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
city: Amarillo
country: United States
facility: Amarillo Heart Group
state: Texas
city: Charlottesville
country: United States
facility: University of Virginia
state: Virginia
city: Lynchburg
country: United States
facility: Centra Medical Group
state: Virginia
city: Spokane
country: United States
facility: Heart Clinics Northwest
state: Washington
city: Leuven
country: Belgium
facility: UZ Leuven - Campus Gasthuisberg
city: Calgary
country: Canada
facility: Libin Cardiovascular Institute of Alberta
state: Alberta
city: Edmonton
country: Canada
facility: Royal Alexandra Hospital
state: Alberta
city: Edmonton
country: Canada
facility: University of Alberta Hospital
state: Alberta
city: New Westminster
country: Canada
facility: Fraser Clinical Trials
state: British Columbia
city: Vancouver
country: Canada
facility: Vancouver General Hospital
state: British Columbia
city: Vancouver
country: Canada
facility: St. Paul's Hospital/Providence Health Care
state: British Columbia
city: Victoria
country: Canada
facility: Victoria Cardiac Arrhythmia Trials
state: British Columbia
city: Winnipeg
country: Canada
facility: St. Boniface Hospital
state: Manitoba
city: Winnipeg
country: Canada
facility: Cardio 1
state: Manitoba
city: St. John
country: Canada
facility: New Brunswick Heart Centre
state: New Brunswick
city: Halifax
country: Canada
facility: Queen Elizabeth II Health Sciences Center
state: Nova Scotia
city: Cambridge
country: Canada
facility: Cambridge Cardiac Care Centre
state: Ontario
city: Hamilton
country: Canada
facility: Hamilton Health Sciences Centre
state: Ontario
city: London
country: Canada
facility: University of Western Ontario
state: Ontario
city: Newmarket
country: Canada
facility: Southlake
state: Ontario
city: Ottawa
country: Canada
facility: Ottawa Heart Institute
state: Ontario
city: Toronto
country: Canada
facility: Sunnybrook Health Sciences Centre
state: Ontario
city: Toronto
country: Canada
facility: St. Michael's Hospital
state: Ontario
city: Toronto
country: Canada
facility: Toronto General Hospital
state: Ontario
city: Montreal
country: Canada
facility: Montreal Heart Institute
state: Quebec
city: Montreal
country: Canada
facility: CHUM
state: Quebec
city: Montreal
country: Canada
facility: McGill University Health Centre
state: Quebec
city: Sherbrooke
country: Canada
facility: Centre Hospitalier Universitaire de Sherbrooke (CHUS)
state: Quebec
city: Trois-Rivieres
country: Canada
facility: Centre Hospitalier Universitaire Regional de Trois-Rivieres (CHRTR)
state: Quebec
city: Regina
country: Canada
facility: Prairie Vascular Research Network
state: Saskatchewan
city: Saskatoon
country: Canada
facility: Royal University Hospital
state: Saskatchewan
city: Laval
country: Canada
facility: Quebec Heart Institute
city: Helsinki
country: Finland
facility: HUCH Helsinki University Central Hospital
city: Oulu
country: Finland
facility: University of Oulu
city: Brest
country: France
facility: CHRU Brest - Hôpital de la Cavale Blanche
city: Nantes
country: France
facility: Hôpital Guillaume et René Laënnec - CHU de Nantes
city: Toulouse
country: France
facility: Clinique Pasteur
city: Göttingen
country: Germany
facility: Universitätsmedizin Göttingen Georg-August-Universität
city: Zalaegerszeg
country: Hungary
facility: Zala Megyei Kórház
city: Bergamo
country: Italy
facility: Azienda Ospedaliera Papa Giovanni XXIII
city: Bologna
country: Italy
facility: Policlinico Sant' Orsola - Malpighi
city: Pavia
country: Italy
facility: Fondazione IRCCS Policlinico San Matteo
city: Oslo
country: Norway
facility: Oslo Universitetssykehus Rikshospitalet
city: Riyadh
country: Saudi Arabia
facility: King Saud University
city: Bratislava
country: Slovakia
facility: Slovak Medical University in Bratislava
city: Centurion
country: South Africa
facility: Unitas Hospital
city: Alicante
country: Spain
facility: Hospital General Universitario de Alicante (HGUA)
city: Barcelona
country: Spain
facility: Hospital Universitario Clinic de Barcelona
city: Madrid
country: Spain
facility: Hospital Universitario La Paz
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre
city: Madrid
country: Spain
facility: Hospital Universitario La Paz
city: Örebro
country: Sweden
facility: Universitetssjukhuset Örebro
city: Liverpool
country: United Kingdom
facility: Liverpool Heart and Chest Hospital
city: Swindon
country: United Kingdom
facility: Great Western Hospital NHS Trust
Study officials:
affiliation: University of Calgary
name: Derek V Exner, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Perkiomaki J, Exner DV, Piira OP, Kavanagh K, Lepojarvi 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.