Efficacy of Implantable Defibrillator Therapy After a Myocardial Infarction

Myocardial Infarction Clinical Trial

— REFINE-ICD  

Official title:

Risk Estimation Following Infarction Noninvasive Evaluation - ICD Efficacy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00673842
• Other study ID #: 21721
• Status: Recruiting
• Phase: Phase 3
• Start date: March 2011
• Est. completion date: December 31, 2024

Study information

• Verified date: March 2024
• Source: University of Calgary
• Contact: Derek V Exner, MD, MPH
• Phone: 403-220-3219
• Email: exner[@]ucalgary.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 700
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Death, Sudden
• Infarction
• Myocardial Infarction
• Sudden Death

Intervention

Device:
• Implantable Cardioverter Defibrillator + Usual Care
Any Medtronic approved single chamber or dual chamber implantable cardioverter defibrillator (ICD)

Other:
• Usual care
Usual post-MI care

Locations

Country	Name	City	State
Belgium	UZ Leuven - Campus Gasthuisberg	Leuven
Canada	Libin Cardiovascular Institute of Alberta	Calgary	Alberta
Canada	Cambridge Cardiac Care Centre	Cambridge	Ontario
Canada	Royal Alexandra Hospital	Edmonton	Alberta
Canada	University of Alberta Hospital	Edmonton	Alberta
Canada	Queen Elizabeth II Health Sciences Center	Halifax	Nova Scotia
Canada	Hamilton Health Sciences Centre	Hamilton	Ontario
Canada	Hamilton Health Sciences II	Hamilton	Ontario
Canada	Quebec Heart Institute	Laval
Canada	University of Western Ontario	London	Ontario
Canada	CHUM	Montreal	Quebec
Canada	McGill University Health Centre	Montreal	Quebec
Canada	Montreal Heart Institute	Montreal	Quebec
Canada	Fraser Clinical Trials	New Westminster	British Columbia
Canada	Southlake	Newmarket	Ontario
Canada	Ottawa Heart Institute	Ottawa	Ontario
Canada	Prairie Vascular Research Network	Regina	Saskatchewan
Canada	Royal University Hospital	Saskatoon	Saskatchewan
Canada	Centre Hospitalier Universitaire de Sherbrooke (CHUS)	Sherbrooke	Quebec
Canada	Memorial University of Newfoundland	St Johns	Newfoundland and Labrador
Canada	New Brunswick Heart Centre	St. John	New Brunswick
Canada	St. Michael's Hospital	Toronto	Ontario
Canada	Sunnybrook Health Sciences Centre	Toronto	Ontario
Canada	Toronto General Hospital	Toronto	Ontario
Canada	Centre Hospitalier Universitaire Regional de Trois-Rivieres (CHRTR)	Trois-Rivieres	Quebec
Canada	St. Paul's Hospital/Providence Health Care	Vancouver	British Columbia
Canada	Vancouver General Hospital	Vancouver	British Columbia
Canada	Victoria Cardiac Arrhythmia Trials	Victoria	British Columbia
Canada	Cardio 1	Winnipeg	Manitoba
Canada	St. Boniface Hospital	Winnipeg	Manitoba
Finland	HUCH Helsinki University Central Hospital	Helsinki
Finland	University of Oulu	Oulu
France	CHRU Brest - Hôpital de la Cavale Blanche	Brest
France	Hôpital Guillaume et René Laënnec - CHU de Nantes	Nantes
France	Hôpital Guillaume et René Laënnec - CHU de Nantes	Nantes
France	Clinique Pasteur	Toulouse
Germany	Universitätsmedizin Göttingen Georg-August-Universität	Göttingen
Hungary	Zala Megyei Kórház	Zalaegerszeg
Italy	Azienda Ospedaliera Papa Giovanni XXIII	Bergamo
Italy	Policlinico Sant' Orsola - Malpighi	Bologna
Italy	Fondazione IRCCS Policlinico San Matteo	Pavia
Norway	Oslo Universitetssykehus Rikshospitalet	Oslo
Saudi Arabia	King Saud University	Riyadh
Slovakia	Slovak Medical University in Bratislava	Bratislava
South Africa	Unitas Hospital	Centurion
Spain	Hospital General Universitario de Alicante (HGUA)	Alicante
Spain	Hospital Universitario Clinic de Barcelona	Barcelona
Spain	Hospital Universitario 12 de Octubre	Madrid
Spain	Hospital Universitario La Paz	Madrid
Spain	Hospital Universitario La Paz	Madrid
Sweden	Universitetssjukhuset Örebro	Örebro
United Kingdom	Liverpool Heart and Chest Hospital	Liverpool
United Kingdom	Great Western Hospital NHS Trust	Swindon
United States	Northeast Ohio Cardiovascular Specialists	Akron	Ohio
United States	Amarillo Heart Group	Amarillo	Texas
United States	Beth Israel Deaconess	Boston	Massachusetts
United States	Carolinas Medical Center	Charlotte	North Carolina
United States	University of Virginia	Charlottesville	Virginia
United States	Bethesda North Hospital	Cincinnati	Ohio
United States	The Lindner Research Center	Cincinnati	Ohio
United States	Cleveland Clinic	Cleveland	Ohio
United States	South Carolina Heart Center	Columbia	South Carolina
United States	The Ohio State University	Columbus	Ohio
United States	Doylestown Cardiology	Doylestown	Pennsylvania
United States	Hamot Medical Center	Erie	Pennsylvania
United States	The Heart Group/Deaconess	Evansville	Indiana
United States	Pee Dee Cardiology	Florence	South Carolina
United States	Cardiovascular Consultants Heart Center	Fresno	California
United States	Greenville Hospital System	Greenville	South Carolina
United States	Hartford Hospital	Hartford	Connecticut
United States	Heart Center Research LLC	Huntsville	Alabama
United States	Watson Clinic	Lakeland	Florida
United States	Colorado Heart and Vascular	Lakewood	Colorado
United States	Centra Medical Group	Lynchburg	Virginia
United States	Aurora St. Luke's Medical Center/Aurora Cardiovascular Services	Milwaukee	Wisconsin
United States	Wheaton Franciscan Healthcare	Milwaukee	Wisconsin
United States	St. Thomas Research Institute	Nashville	Tennessee
United States	Vanderbilt University Medical Center	Nashville	Tennessee
United States	Yale University	New Haven	Connecticut
United States	New York Presbyterian Hospital	New York	New York
United States	North Shore LIJ	New York	New York
United States	University of Pennsylvania	Philadelphia	Pennsylvania
United States	University of Pittsburgh Medical Center UPMC Presbyterian	Pittsburgh	Pennsylvania
United States	The Valley Hospital	Ridgewood	New Jersey
United States	Washington University Medical School	Saint Louis	Michigan
United States	Delmarva Heart Foundation	Salisbury	Maryland
United States	St. John Providence Hospital	Southfield	Michigan
United States	Spartanburg Regional Healthcare System	Spartanburg	South Carolina
United States	Heart Clinics Northwest	Spokane	Washington
United States	Lester E Cox Medical Center	Springfield	Missouri
United States	James A Haley Veterans' Center	Tampa	Florida
United States	Scott & White Healthcare	Temple	Texas
United States	Associated Cardiovascular Consultants/Lourdes Cardiology Services	Voorhees	New Jersey
United States	Iowa Heart Center	West Des Moines	Iowa
United States	Geisinger Wyoming Valley Medical Center	Wilkes-Barre	Pennsylvania

Sponsors (7)

Lead Sponsor	Collaborator
University of Calgary	Accelerating Clinical Trials Consortium, Alberta Innovation and Science, Canadian Institutes of Health Research (CIHR), Cardiac Arrhythmia Network of Canada, GE Healthcare, Medtronic

Countries where clinical trial is conducted

United States,  Belgium,  Canada,  Finland,  France,  Germany,  Hungary,  Italy,  Norway,  Saudi Arabia,  Slovakia,  South Africa,  Spain,  Sweden,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mortality		Minimum of 18 months of follow-up (average follow-up of 5 years).
Secondary	Cardiac death		Average follow-up 5 years.
Secondary	Arrhythmic death		Average follow-up 5 years.
Secondary	Arrhythmic syncope		Average follow-up 5 years.
Secondary	Appropriate ICD therapies		Average follow-up 5 years.
Secondary	Quality of life		Average follow-up 5 years.
Secondary	Inappropriate ICD therapies		Five years (average)

External Links

•   Study Website