Huntsville, Alabama 35801

  • Sudden Death

Purpose:

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.


Study summary:

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.


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


Study is Available At:


Original ID:

21721


NCT ID:

NCT00673842


Secondary ID:


Study Acronym:

REFINE-ICD


Brief Title:

Efficacy of Implantable Defibrillator Therapy After a Myocardial Infarction


Official Title:

Risk Estimation Following Infarction Noninvasive Evaluation - ICD Efficacy


Overall Status:

Recruiting


Study Phase:

Phase 3


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

80 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

University of Calgary


Oversight Authority:

Canada: Health Canada


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Randomized, Endpoint Classification: E


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

1000


Enrollment Type:

Anticipated


Overall Contact Information

Official Name:Derek V Exner, MD, MPH
Principal Investigator
University of Calgary
Primary Contact:Derek V Exner, MD, MPH
403-220-3219
exner@ucalgary.ca
Backup Contact:Caroline (Liong Eng) Tan-Mesiatowsky, MD
403-210-7396
letanmes@ucalgary.ca

Study Dates

Start Date:March 2011
Completion Date:December 2021
Completion Type:Anticipated
Primary Completion Date:January 2019
Primary Completion Type:Anticipated
Verification Date:July 2016
Last Changed Date:July 7, 2016
First Received Date:April 29, 2008

Study Outcomes

Outcome Type:Primary Outcome
Measure:Mortality
Time Frame:Minimum of 18 months of follow-up (average follow-up of 5 years).
Safety Issues:True
Outcome Type:Secondary Outcome
Measure:Cardiac death
Time Frame:Average follow-up 5 years.
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Arrhythmic death
Time Frame:Average follow-up 5 years.
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Arrhythmic syncope
Time Frame:Average follow-up 5 years.
Safety Issues:True
Outcome Type:Secondary Outcome
Measure:Appropriate ICD therapies
Time Frame:Average follow-up 5 years.
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Quality of life
Time Frame:Average follow-up 5 years.
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Inappropriate ICD therapies
Time Frame:Five years (average)
Safety Issues:False

Study Interventions

Intervention Type:Device
Name:Implantable Cardioverter Defibrillator + Usual Car
Description:Any Medtronic approved (in each geography) single chamber or dual chamber implantable cardioverter defibrillator (ICD)
Arm Name:Implantable Cardioverter Defibrillator + Usual Car
Other Name:Implantable Cardioverter Defibrillator
Intervention Type:Other
Name:Usual care
Description:Usual post-MI care
Arm Name:Usual Care
Other Name:Standard medical therapy alone

Study Arms

Study Arm Type:Active Comparator
Arm Name:Usual Care
Description:Usual post-MI care
Study Arm Type:Experimental
Arm Name:Implantable Cardioverter Defibrillator + Usual Care
Description:Medtronic ICD

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:University of Calgary
Agency Class:Other
Agency Type:Collaborator
Agency Name:Canadian Institutes of Health Research (CIHR)

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: February 03, 2023

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