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

This study has been terminated.
(Poor recruitment)
Sponsor:
Collaborators:
Institute for Clinical Evaluative Sciences
Ontario Ministry of Health and Long Term Care
Information provided by:
St. Michael's Hospital, Toronto
ClinicalTrials.gov Identifier:
NCT00524862
First received: August 29, 2007
Last updated: January 5, 2009
Last verified: May 2008
History of Changes
  Purpose

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 Intervention
Coronary Heart Disease
Congestive Heart Failure
Ventricular Dysfunction
Low Cardiac Output
Sudden Cardiac Death
 Drug: Optimized medical therapy
Device: Implantable Cardioverter Defibrillator

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Selective Strategy to Manage Arrhythmia Risk and Therapy With ICD

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by St. Michael's Hospital, Toronto:

Primary Outcome Measures:
  • All-cause mortality [ Time Frame: minimum 1 year follow-up (maximum 6 year) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 5000
Study Start Date: October 2007
Estimated Study Completion Date: April 2011
Estimated Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00524862

Locations
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
University Health Network - Toronto General Hospital
Toronto, Ontario, Canada, M5G 2C4
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada, M4N 3M5
St. Michael's Hospital
Toronto, Ontario, Canada, M5B 1W8
Sponsors and Collaborators
St. Michael's Hospital, Toronto
Institute for Clinical Evaluative Sciences
Ontario Ministry of Health and Long Term Care
Investigators
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
  More Information

No publications provided

Responsible Party: Prinicipal Investigator, St. Michael's Hospital
ClinicalTrials.gov Identifier: NCT00524862     History of Changes
Other Study ID Numbers: 06368
Study First Received: August 29, 2007
Last Updated: January 5, 2009
Health Authority: Canada: Ministry of Health & Long Term Care, Ontario

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

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

ClinicalTrials.gov processed this record on May 19, 2013