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

Primary Purpose

Myocardial Infarction, Sudden Death

Status
Unknown status
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Implantable Cardioverter Defibrillator + Usual Care
Usual care
Sponsored by
University of Calgary
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Myocardial Infarction focused on measuring Noninvasive assessment, Holter

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Heart Center Research LLCRecruiting
  • Heart Center Research LLC
  • Cardiovascular Consultants Heart Center
  • Colorado Heart and Vascular
  • Hartford Hospital
  • Yale University
  • Watson Clinic
  • James A Haley Veterans' Center
  • The Heart Group/Deaconess
  • Iowa Heart Center
  • Delmarva Heart Foundation
  • Beth Israel Deaconess
  • Washington University Medical School
  • St. John Providence HospitalRecruiting
  • Lester E Cox Medical Center
  • The Valley Hospital
  • Associated Cardiovascular Consultants/Lourdes Cardiology Services
  • North Shore LIJ
  • New York Presbyterian Hospital
  • Carolinas Medical Center
  • Northeast Ohio Cardiovascular Specialists
  • The Lindner Research Center
  • Bethesda North Hospital
  • Cleveland Clinic
  • The Ohio State University
  • Doylestown Cardiology
  • Hamot Medical Center
  • University of Pennsylvania
  • University of Pittsburgh Medical Center UPMC Presbyterian
  • Geisinger Wyoming Valley Medical Center
  • South Carolina Heart Center
  • Pee Dee Cardiology
  • Greenville Hospital System
  • Spartanburg Regional Healthcare System
  • St. Thomas Research Institute
  • Vanderbilt University Medical Center
  • Amarillo Heart Group
  • Scott & White Healthcare
  • University of Virginia
  • Centra Medical Group
  • Heart Clinics Northwest
  • Wheaton Franciscan Healthcare
  • Aurora St. Luke's Medical Center/Aurora Cardiovascular Services
  • UZ Leuven - Campus Gasthuisberg
  • Libin Cardiovascular Institute of AlbertaRecruiting
  • Royal Alexandra HospitalRecruiting
  • University of Alberta HospitalRecruiting
  • Fraser Clinical TrialsRecruiting
  • Vancouver General HospitalRecruiting
  • St. Paul's Hospital/Providence Health CareRecruiting
  • Victoria Cardiac Arrhythmia TrialsRecruiting
  • St. Boniface HospitalRecruiting
  • New Brunswick Heart CentreRecruiting
  • Memorial University of NewfoundlandRecruiting
  • Queen Elizabeth II Health Sciences CenterRecruiting
  • Hamilton Health Sciences CentreRecruiting
  • Hamilton Health Sciences II
  • University of Western OntarioRecruiting
  • SouthlakeRecruiting
  • Ottawa Heart InstituteRecruiting
  • Sunnybrook Health Sciences CentreRecruiting
  • St. Michael's HospitalRecruiting
  • Toronto General HospitalRecruiting
  • Montreal Heart InstituteRecruiting
  • CHUMRecruiting
  • McGill University Health CentreRecruiting
  • Centre Hospitalier Universitaire de Sherbrooke (CHUS)Recruiting
  • Centre Hospitalier Universitaire Regional de Trois-Rivieres (CHRTR)Recruiting
  • Prairie Vascular Research NetworkRecruiting
  • Royal University HospitalRecruiting
  • Quebec Heart InstituteRecruiting
  • HUCH Helsinki University Central Hospital
  • University of Oulu
  • CHRU Brest - Hôpital de la Cavale Blanche
  • Hôpital Guillaume et René Laënnec - CHU de Nantes
  • Hôpital Guillaume et René Laënnec - CHU de Nantes
  • Clinique Pasteur
  • Universitätsmedizin Göttingen Georg-August-Universität
  • Zala Megyei Kórház
  • Azienda Ospedaliera Papa Giovanni XXIII
  • Policlinico Sant' Orsola - Malpighi
  • Fondazione IRCCS Policlinico San Matteo
  • Oslo Universitetssykehus Rikshospitalet
  • King Saud University
  • Slovak Medical University in Bratislava
  • Unitas Hospital
  • Hospital General Universitario de Alicante (HGUA)
  • Hospital Universitario Clinic de Barcelona
  • Hospital Universitario La Paz
  • Hospital Universitario 12 de Octubre
  • Hospital Universitario La Paz
  • Universitetssjukhuset Örebro
  • Liverpool Heart and Chest Hospital
  • Great Western Hospital NHS Trust

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Implantable Cardioverter Defibrillator + Usual Care

Usual Care

Arm Description

Medtronic ICD

Usual post-MI care

Outcomes

Primary Outcome Measures

Mortality

Secondary Outcome Measures

Cardiac death
Arrhythmic death
Arrhythmic syncope
Appropriate ICD therapies
Quality of life
Inappropriate ICD therapies

Full Information

First Posted
April 29, 2008
Last Updated
July 7, 2016
Sponsor
University of Calgary
Collaborators
Canadian Institutes of Health Research (CIHR), Alberta Innovation and Science, Medtronic, GE Healthcare
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1. Study Identification

Unique Protocol Identification Number
NCT00673842
Brief Title
Efficacy of Implantable Defibrillator Therapy After a Myocardial Infarction
Acronym
REFINE-ICD
Official Title
Risk Estimation Following Infarction Noninvasive Evaluation - ICD Efficacy
Study Type
Interventional

2. Study Status

Record Verification Date
July 2016
Overall Recruitment Status
Unknown status
Study Start Date
March 2011 (undefined)
Primary Completion Date
January 2019 (Anticipated)
Study Completion Date
December 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Calgary
Collaborators
Canadian Institutes of Health Research (CIHR), Alberta Innovation and Science, Medtronic, GE Healthcare

4. Oversight

Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myocardial Infarction, Sudden Death
Keywords
Noninvasive assessment, Holter

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1000 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Implantable Cardioverter Defibrillator + Usual Care
Arm Type
Experimental
Arm Description
Medtronic ICD
Arm Title
Usual Care
Arm Type
Active Comparator
Arm Description
Usual post-MI care
Intervention Type
Device
Intervention Name(s)
Implantable Cardioverter Defibrillator + Usual Care
Other Intervention Name(s)
Implantable Cardioverter Defibrillator, ICD
Intervention Description
Any Medtronic approved (in each geography) single chamber or dual chamber implantable cardioverter defibrillator (ICD)
Intervention Type
Other
Intervention Name(s)
Usual care
Other Intervention Name(s)
Standard medical therapy alone
Intervention Description
Usual post-MI care
Primary Outcome Measure Information:
Title
Mortality
Time Frame
Minimum of 18 months of follow-up (average follow-up of 5 years).
Secondary Outcome Measure Information:
Title
Cardiac death
Time Frame
Average follow-up 5 years.
Title
Arrhythmic death
Time Frame
Average follow-up 5 years.
Title
Arrhythmic syncope
Time Frame
Average follow-up 5 years.
Title
Appropriate ICD therapies
Time Frame
Average follow-up 5 years.
Title
Quality of life
Time Frame
Average follow-up 5 years.
Title
Inappropriate ICD therapies
Time Frame
Five years (average)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Derek V Exner, MD, MPH
Phone
403-220-3219
Email
exner@ucalgary.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Caroline (Liong Eng) Tan-Mesiatowsky, MD
Phone
403-210-7396
Email
letanmes@ucalgary.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Derek V Exner, MD, MPH
Organizational Affiliation
University of Calgary
Official's Role
Principal Investigator
Facility Information:
Facility Name
Heart Center Research LLC
City
Huntsville
State/Province
Alabama
ZIP/Postal Code
35801
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jessica Marsh, RN
Phone
256-519-8143
Email
jmarsh@theheartcenter.md
First Name & Middle Initial & Last Name & Degree
Jay Dinerman, MD
Facility Name
Heart Center Research LLC
City
Huntsville
State/Province
Alabama
ZIP/Postal Code
35801
Country
United States
Individual Site Status
Completed
Facility Name
Cardiovascular Consultants Heart Center
City
Fresno
State/Province
California
ZIP/Postal Code
93720
Country
United States
Individual Site Status
Withdrawn
Facility Name
Colorado Heart and Vascular
City
Lakewood
State/Province
Colorado
ZIP/Postal Code
80228
Country
United States
Individual Site Status
Completed
Facility Name
Hartford Hospital
City
Hartford
State/Province
Connecticut
ZIP/Postal Code
06106
Country
United States
Individual Site Status
Withdrawn
Facility Name
Yale University
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06519
Country
United States
Individual Site Status
Withdrawn
Facility Name
Watson Clinic
City
Lakeland
State/Province
Florida
ZIP/Postal Code
33805
Country
United States
Individual Site Status
Withdrawn
Facility Name
James A Haley Veterans' Center
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Individual Site Status
Completed
Facility Name
The Heart Group/Deaconess
City
Evansville
State/Province
Indiana
ZIP/Postal Code
47630
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Iowa Heart Center
City
West Des Moines
State/Province
Iowa
ZIP/Postal Code
50266
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Delmarva Heart Foundation
City
Salisbury
State/Province
Maryland
ZIP/Postal Code
21804
Country
United States
Individual Site Status
Completed
Facility Name
Beth Israel Deaconess
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Individual Site Status
Completed
Facility Name
Washington University Medical School
City
Saint Louis
State/Province
Michigan
ZIP/Postal Code
63110
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
St. John Providence Hospital
City
Southfield
State/Province
Michigan
ZIP/Postal Code
48075
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cordell Hastings
Email
Cordell.Hastings@providence-stjohnhealth.org
First Name & Middle Initial & Last Name & Degree
Christian Michado, MD
Facility Name
Lester E Cox Medical Center
City
Springfield
State/Province
Missouri
ZIP/Postal Code
65807
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
The Valley Hospital
City
Ridgewood
State/Province
New Jersey
ZIP/Postal Code
07450
Country
United States
Individual Site Status
Completed
Facility Name
Associated Cardiovascular Consultants/Lourdes Cardiology Services
City
Voorhees
State/Province
New Jersey
ZIP/Postal Code
08034
Country
United States
Individual Site Status
Terminated
Facility Name
North Shore LIJ
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Individual Site Status
Completed
Facility Name
New York Presbyterian Hospital
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Individual Site Status
Completed
Facility Name
Carolinas Medical Center
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28203
Country
United States
Individual Site Status
Withdrawn
Facility Name
Northeast Ohio Cardiovascular Specialists
City
Akron
State/Province
Ohio
ZIP/Postal Code
44304
Country
United States
Individual Site Status
Completed
Facility Name
The Lindner Research Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Individual Site Status
Completed
Facility Name
Bethesda North Hospital
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45242
Country
United States
Individual Site Status
Completed
Facility Name
Cleveland Clinic
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Individual Site Status
Completed
Facility Name
The Ohio State University
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Individual Site Status
Completed
Facility Name
Doylestown Cardiology
City
Doylestown
State/Province
Pennsylvania
ZIP/Postal Code
18901
Country
United States
Individual Site Status
Completed
Facility Name
Hamot Medical Center
City
Erie
State/Province
Pennsylvania
ZIP/Postal Code
16550
Country
United States
Individual Site Status
Withdrawn
Facility Name
University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Individual Site Status
Withdrawn
Facility Name
University of Pittsburgh Medical Center UPMC Presbyterian
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Individual Site Status
Completed
Facility Name
Geisinger Wyoming Valley Medical Center
City
Wilkes-Barre
State/Province
Pennsylvania
ZIP/Postal Code
18722
Country
United States
Individual Site Status
Completed
Facility Name
South Carolina Heart Center
City
Columbia
State/Province
South Carolina
ZIP/Postal Code
29204
Country
United States
Individual Site Status
Withdrawn
Facility Name
Pee Dee Cardiology
City
Florence
State/Province
South Carolina
ZIP/Postal Code
29506
Country
United States
Individual Site Status
Withdrawn
Facility Name
Greenville Hospital System
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29605
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Spartanburg Regional Healthcare System
City
Spartanburg
State/Province
South Carolina
ZIP/Postal Code
29303
Country
United States
Individual Site Status
Withdrawn
Facility Name
St. Thomas Research Institute
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Individual Site Status
Terminated
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Amarillo Heart Group
City
Amarillo
State/Province
Texas
ZIP/Postal Code
79106
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Scott & White Healthcare
City
Temple
State/Province
Texas
ZIP/Postal Code
76508
Country
United States
Individual Site Status
Withdrawn
Facility Name
University of Virginia
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22908
Country
United States
Individual Site Status
Completed
Facility Name
Centra Medical Group
City
Lynchburg
State/Province
Virginia
ZIP/Postal Code
24510
Country
United States
Individual Site Status
Completed
Facility Name
Heart Clinics Northwest
City
Spokane
State/Province
Washington
ZIP/Postal Code
99204
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Wheaton Franciscan Healthcare
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53210
Country
United States
Individual Site Status
Withdrawn
Facility Name
Aurora St. Luke's Medical Center/Aurora Cardiovascular Services
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53215
Country
United States
Individual Site Status
Withdrawn
Facility Name
UZ Leuven - Campus Gasthuisberg
City
Leuven
Country
Belgium
Individual Site Status
Active, not recruiting
Facility Name
Libin Cardiovascular Institute of Alberta
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 4Z6
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Micheline Deschenes, PhD
Email
mcdesche@ucalgary.ca
First Name & Middle Initial & Last Name & Degree
Katherine M Kavanagh, MD
Facility Name
Royal Alexandra Hospital
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T5H 3V9
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sylvia Martin, RN
Email
Sylvia.Martin@albertahealthservices.ca
First Name & Middle Initial & Last Name & Degree
Evan Lockwood, MD
Facility Name
University of Alberta Hospital
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 2B7
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maria Raines, RN
Email
Maria.Raines@albertahealthservices.ca
First Name & Middle Initial & Last Name & Degree
Tomasz Hruczkowski, MD
Facility Name
Fraser Clinical Trials
City
New Westminster
State/Province
British Columbia
ZIP/Postal Code
V3L 3W4
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shirley Lim-Uy, RN
Email
suy@fraserclinicaltrials.com
First Name & Middle Initial & Last Name & Degree
John LeMaitre, MD
Facility Name
Vancouver General Hospital
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 1M9
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ngaire Meadows, RN
Email
ngaire.meadows2@vch.ca
First Name & Middle Initial & Last Name & Degree
Matthew Bennett, MD
Facility Name
St. Paul's Hospital/Providence Health Care
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6E 1M7
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marion Thomas
Email
mthomas@providencehealth.bc.ca
First Name & Middle Initial & Last Name & Degree
Marc Deyell, MD
Facility Name
Victoria Cardiac Arrhythmia Trials
City
Victoria
State/Province
British Columbia
ZIP/Postal Code
V8R 4R2
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Deborah Parfett, RN
Email
dparfett@catrials.org
First Name & Middle Initial & Last Name & Degree
Laurence Sterns, MD
Facility Name
St. Boniface Hospital
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R2H 2A6
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rebecca Medeiros, RN
Email
rmedeiros@sbgh.mb.ca
First Name & Middle Initial & Last Name & Degree
Colette Seifer, MD
Facility Name
New Brunswick Heart Centre
City
St. John
State/Province
New Brunswick
ZIP/Postal Code
E2L 2L4
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gail O' Blenis, RN
Email
gailoblenis@gmail.com
First Name & Middle Initial & Last Name & Degree
Satish Toal, MD
Facility Name
Memorial University of Newfoundland
City
St Johns
State/Province
Newfoundland and Labrador
ZIP/Postal Code
A1B 3V6
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Diane Spurrell, RN
Email
diane.spurrell@easternhealth.ca
First Name & Middle Initial & Last Name & Degree
Sean Connors, MD, PhD
Facility Name
Queen Elizabeth II Health Sciences Center
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3H 3A7
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lisa Hebert, RN
Email
lisa.hebert@nshealth.ca
First Name & Middle Initial & Last Name & Degree
John Sapp, MD
Facility Name
Hamilton Health Sciences Centre
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8L 2X2
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ruth Chinchilla, RN
Email
chinchill@hhsc.ca
First Name & Middle Initial & Last Name & Degree
Jeffrey Healey, MD
Facility Name
Hamilton Health Sciences II
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8L 2X2
Country
Canada
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sonya Brons, RN
Email
bronsson@hhsc.ca
First Name & Middle Initial & Last Name & Degree
Shamir Mehta, MD
Facility Name
University of Western Ontario
City
London
State/Province
Ontario
ZIP/Postal Code
N0L 1W0
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Patricia Burrows, RN
Email
patricia.burrows@lhsc.on.ca
First Name & Middle Initial & Last Name & Degree
RN
First Name & Middle Initial & Last Name & Degree
Raymond Yee, MD
Facility Name
Southlake
City
Newmarket
State/Province
Ontario
ZIP/Postal Code
L3Y 2P9
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Annette Nath, RN
Email
anath@southlakeregional.org
First Name & Middle Initial & Last Name & Degree
Yaariv Khaykin, MD
Facility Name
Ottawa Heart Institute
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1Y 4W7
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tammy Knight, RN
Email
tknight@ottawaheart.ca
First Name & Middle Initial & Last Name & Degree
Girish Nair, MD
First Name & Middle Initial & Last Name & Degree
David Birnie, MD
Facility Name
Sunnybrook Health Sciences Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4N 3N5
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fahema Ahmadzai, RN
Email
fahema.ahmadzai@sunnybrook.ca
First Name & Middle Initial & Last Name & Degree
Eugene Crystal, MD
Facility Name
St. Michael's Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5B 1W8
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marta Gadacz
Email
gadaczm@smh.ca
First Name & Middle Initial & Last Name & Degree
Paul Angaran, MD
Facility Name
Toronto General Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2C4
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ann Hill, RN
Email
ann.hill@uhn.ca
First Name & Middle Initial & Last Name & Degree
Andrew Ha, MD
Facility Name
Montreal Heart Institute
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H1T 1C8
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Francois Lemarbre, RN
Email
francois.lemarbre@icm-mhi.org
First Name & Middle Initial & Last Name & Degree
Bernard Thibault, MD
Facility Name
CHUM
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2W 1T8
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Martine Bergeron
Email
martine.bergeron@crchum.qc.ca
First Name & Middle Initial & Last Name & Degree
Benoit Coutu, MD
Facility Name
McGill University Health Centre
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3G 1A4
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fiorella Rafti
Email
fiorella.rafti@mail.mcgill.ca
First Name & Middle Initial & Last Name & Degree
Vidal Essebag, MD, PhD
Facility Name
Centre Hospitalier Universitaire de Sherbrooke (CHUS)
City
Sherbrooke
State/Province
Quebec
ZIP/Postal Code
J1H 5N4
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Veronique Dagenais, RN
Email
vdagenais.chus@ssss.gouv.qc.ca
First Name & Middle Initial & Last Name & Degree
Mariano Badra-Verdu, MD
Facility Name
Centre Hospitalier Universitaire Regional de Trois-Rivieres (CHRTR)
City
Trois-Rivieres
State/Province
Quebec
ZIP/Postal Code
G8Z 3R9
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Isabelle Roy, RN
Email
isabelle_roy_chrtr@ssss.gouv.qc.ca
First Name & Middle Initial & Last Name & Degree
Ariel Diaz, MD
Facility Name
Prairie Vascular Research Network
City
Regina
State/Province
Saskatchewan
ZIP/Postal Code
S4P 0W5
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sheila Kelly
Email
sheila@skresearch.com
First Name & Middle Initial & Last Name & Degree
Omar Sultan, MD
First Name & Middle Initial & Last Name & Degree
Payam Dehghani, MD
Facility Name
Royal University Hospital
City
Saskatoon
State/Province
Saskatchewan
ZIP/Postal Code
S7N 0W8
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lynn Zinger
Email
lynn.zinger@saskatoonhealthregion.ca
First Name & Middle Initial & Last Name & Degree
Kelly Coverett, MD
Facility Name
Quebec Heart Institute
City
Laval
ZIP/Postal Code
G1V 4G5
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Julie Robinson, RN
Email
julie.robinson@criucpq.ulaval.ca
First Name & Middle Initial & Last Name & Degree
Francois Philippon, MD
Facility Name
HUCH Helsinki University Central Hospital
City
Helsinki
Country
Finland
Individual Site Status
Active, not recruiting
Facility Name
University of Oulu
City
Oulu
Country
Finland
Individual Site Status
Active, not recruiting
Facility Name
CHRU Brest - Hôpital de la Cavale Blanche
City
Brest
Country
France
Individual Site Status
Completed
Facility Name
Hôpital Guillaume et René Laënnec - CHU de Nantes
City
Nantes
ZIP/Postal Code
44093
Country
France
Individual Site Status
Completed
Facility Name
Hôpital Guillaume et René Laënnec - CHU de Nantes
City
Nantes
Country
France
Individual Site Status
Completed
Facility Name
Clinique Pasteur
City
Toulouse
Country
France
Individual Site Status
Completed
Facility Name
Universitätsmedizin Göttingen Georg-August-Universität
City
Göttingen
ZIP/Postal Code
37099
Country
Germany
Individual Site Status
Completed
Facility Name
Zala Megyei Kórház
City
Zalaegerszeg
Country
Hungary
Individual Site Status
Completed
Facility Name
Azienda Ospedaliera Papa Giovanni XXIII
City
Bergamo
Country
Italy
Individual Site Status
Completed
Facility Name
Policlinico Sant' Orsola - Malpighi
City
Bologna
Country
Italy
Individual Site Status
Completed
Facility Name
Fondazione IRCCS Policlinico San Matteo
City
Pavia
Country
Italy
Individual Site Status
Completed
Facility Name
Oslo Universitetssykehus Rikshospitalet
City
Oslo
Country
Norway
Individual Site Status
Active, not recruiting
Facility Name
King Saud University
City
Riyadh
Country
Saudi Arabia
Individual Site Status
Active, not recruiting
Facility Name
Slovak Medical University in Bratislava
City
Bratislava
Country
Slovakia
Individual Site Status
Completed
Facility Name
Unitas Hospital
City
Centurion
Country
South Africa
Individual Site Status
Active, not recruiting
Facility Name
Hospital General Universitario de Alicante (HGUA)
City
Alicante
ZIP/Postal Code
03010
Country
Spain
Individual Site Status
Completed
Facility Name
Hospital Universitario Clinic de Barcelona
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Individual Site Status
Completed
Facility Name
Hospital Universitario La Paz
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Individual Site Status
Completed
Facility Name
Hospital Universitario 12 de Octubre
City
Madrid
Country
Spain
Individual Site Status
Active, not recruiting
Facility Name
Hospital Universitario La Paz
City
Madrid
Country
Spain
Individual Site Status
Completed
Facility Name
Universitetssjukhuset Örebro
City
Örebro
ZIP/Postal Code
70185
Country
Sweden
Individual Site Status
Completed
Facility Name
Liverpool Heart and Chest Hospital
City
Liverpool
Country
United Kingdom
Individual Site Status
Completed
Facility Name
Great Western Hospital NHS Trust
City
Swindon
Country
United Kingdom
Individual Site Status
Completed

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
uncertain
Citations:
PubMed Identifier
25589197
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.
Results Reference
derived
Links:
URL
http://REFINEICD.COM
Description
Study Website

Learn more about this trial

Efficacy of Implantable Defibrillator Therapy After a Myocardial Infarction

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