Standard Drug Therapy vs. Implanted Defibrillator for Primary Prevention of Sudden Cardiac Death (SMART-ICD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00524862
Recruitment Status : Terminated (Poor recruitment)
First Posted : September 5, 2007
Last Update Posted : July 31, 2015
Institute for Clinical Evaluative Sciences
Ontario Ministry of Health and Long Term Care
Information provided by (Responsible Party):
St. Michael's Hospital, Toronto

Brief Summary:
Recent ACC/AHA/ESC guidelines recommend prophylactic ICD implantation in most patients with coronary heart disease and LVEF < 40%. Current Canadian guidelines recommend ICDs for primary prophylaxis in CAD patients with LVEF < 30% (Class I recommendation). There are very sparse data to recommend ICD implantation in patients with EF between 30 and 40 %. This study will randomize patients with CHD and an EF between 30 and 40% to ICD therapy vs. No ICD therapy. The primary outcome is mortality and the study is powered as a non-inferiority trial to test the hypothesis that mortality in patients with no ICD is not more than 1% greater (absolute yearly increase) than patients receiving an ICD.

Condition or disease Intervention/treatment Phase
Coronary Heart Disease Congestive Heart Failure Ventricular Dysfunction Low Cardiac Output Sudden Cardiac Death Drug: Optimized medical therapy Device: Implantable Cardioverter Defibrillator Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 5000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Selective Strategy to Manage Arrhythmia Risk and Therapy With ICD
Study Start Date : October 2007
Actual Primary Completion Date : April 2011
Actual Study Completion Date : April 2011

Arm Intervention/treatment
1 Drug: Optimized medical therapy
Beta Blockers, ACE inhibitor or ARB, loop diuretics and/or spironolactone as appropriate, statin if indicated, aspirin and/or warfarin if indicated

2 Device: Implantable Cardioverter Defibrillator
an implanted device, called a defibrillator, which monitors heart rhythm and treats life-threatening rhythms accordingly
Other Name: ICD

Primary Outcome Measures :
  1. All-cause mortality [ Time Frame: minimum 1 year follow-up (maximum 6 year) ]

Secondary Outcome Measures :
  1. 1. Presumed arrhythmic (sudden death) mortality. 2. Major morbidity which includes mortality, hospitalization and major device complications [ Time Frame: minimum 1 year; maximum 6 years ]

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • documented chronic coronary heart disease (prior MI and/or angiographically documented CAD), > 40 days post the most recent MI;
  • LVEF < 40% (by MUGA) and NYHA functional class II or III at time of assessment OR LVEF ≤ 35 % (by MUGA) and NYHA functional class I, II or III at time of assessment
  • Judged to have a reasonable expectation of survival with a good functional status for more than 1 year, as well as receiving optimum, guideline recommended therapy for coronary artery disease and heart failure (or demonstrated intolerance or contraindications to such therapy).
  • Age ≥ 18 years; no upper age limitation.

Exclusion Criteria:

  • Prior cardiac arrest, sustained VT or VF, or unexplained syncope.
  • Attempted VT / VF induction at electrophysiological study.
  • Need for a cardiac resynchronization therapy (CRT) device.
  • Enrollment in another interventional trial.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00524862

Canada, Ontario
Hamilton Health Sciences - Hamilton General
Hamilton, Ontario, Canada, L8L 2X2
Kingston General Hospital
Kingston, Ontario, Canada, K7L 2V7
London Health Sciences - University Campus
London, Ontario, Canada, N6A 5A5
Trillium Health Centre - Mississauga
Mississauga, Ontario, Canada, L5B 1B8
Southlake Regional Health Centre
Newmarket, Ontario, Canada, L3Y 2P9
University of Ottawa Heart Institute
Ottawa, Ontario, Canada, K1Y 4W7
Rouge Valley Health System - Centenary
Scarborough, Ontario, Canada, M1E 5E9
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada, M4N 3M5
St. Michael's Hospital
Toronto, Ontario, Canada, M5B 1W8
University Health Network - Toronto General Hospital
Toronto, Ontario, Canada, M5G 2C4
Sponsors and Collaborators
St. Michael's Hospital, Toronto
Institute for Clinical Evaluative Sciences
Ontario Ministry of Health and Long Term Care
Study Chair: Paul Dorian, MD St. Michael's Hospital, Toronto
Study Director: Andreas Laupacis, MD Li Ka Shing Knowledge Institute at St. Michael's Hospital
Study Director: Douglas Lee, MD Institute for Clinical Evaluatuve Sciences
Study Director: Kevin Thorpe, MSc Li Ka Shing Knowledge Institute at St. Michael's Hospital
Study Director: Marta Gadacz, MSc St. Michael's Hospital, Toronto

Responsible Party: St. Michael's Hospital, Toronto Identifier: NCT00524862     History of Changes
Other Study ID Numbers: 06368
First Posted: September 5, 2007    Key Record Dates
Last Update Posted: July 31, 2015
Last Verified: July 2015

Keywords provided by St. Michael's Hospital, Toronto:
Implantable Cardioverter Defibrillator
Ejection Fraction
QRS duration

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Coronary Disease
Coronary Artery Disease
Myocardial Ischemia
Ventricular Dysfunction
Death, Sudden, Cardiac
Cardiac Output, Low
Cardiovascular Diseases
Pathologic Processes
Vascular Diseases
Arterial Occlusive Diseases
Heart Arrest
Death, Sudden
Signs and Symptoms