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

Selective Strategy to Manage Arrhythmia Risk and Therapy With ICD

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.

Study Overview

• Status: Terminated
• Conditions: Coronary Heart Disease; Ventricular Dysfunction; Congestive Heart Failure; Sudden Cardiac Death; Low Cardiac Output
• Intervention / Treatment: Drug: Optimized medical therapy; Device: Implantable Cardioverter Defibrillator

• Study Type: Interventional
• Enrollment (Anticipated): 5000
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Hamilton, Ontario, Canada, L8L 2X2
      • Hamilton Health Sciences - Hamilton General
    • Kingston, Ontario, Canada, K7L 2V7
      • Kingston General Hospital
    • London, Ontario, Canada, N6A 5A5
      • London Health Sciences - University Campus
    • Mississauga, Ontario, Canada, L5B 1B8
      • Trillium Health Centre - Mississauga
    • Newmarket, Ontario, Canada, L3Y 2P9
      • Southlake Regional Health Centre
    • Ottawa, Ontario, Canada, K1Y 4W7
      • University of Ottawa Heart Institute
    • Scarborough, Ontario, Canada, M1E 5E9
      • Rouge Valley Health System - Centenary
    • Toronto, Ontario, Canada, M4N 3M5
      • Sunnybrook Health Sciences Centre
    • Toronto, Ontario, Canada, M5B 1W8
      • St. Michael's Hospital
    • Toronto, Ontario, Canada, M5G 2C4
      • University Health Network - Toronto General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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
Other: 2	Device: Implantable Cardioverter Defibrillator; an implanted device, called a defibrillator, which monitors heart rhythm and treats life-threatening rhythms accordingly; Other Names: ICD

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
All-cause mortality	minimum 1 year follow-up (maximum 6 year)

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Unity Health Toronto
• Collaborators: Ontario Ministry of Health and Long Term Care; Institute for Clinical Evaluative Sciences
• Investigators: Study Chair: Paul Dorian, MD, Unity Health 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, Unity Health Toronto

Study record dates

Study Major Dates

• Study Start: October 1, 2007
• Primary Completion (Actual): April 1, 2011
• Study Completion (Actual): April 1, 2011

Study Registration Dates

• First Submitted: August 29, 2007
• First Submitted That Met QC Criteria: August 31, 2007
• First Posted (Estimate): September 5, 2007

Study Record Updates

• Last Update Posted (Estimate): July 31, 2015
• Last Update Submitted That Met QC Criteria: July 30, 2015
• Last Verified: July 1, 2015

More Information

Terms related to this study

• Keywords: Ejection Fraction; Implantable Cardioverter Defibrillator; QRS duration
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Death, Sudden; Heart Arrest; Heart Failure; Heart Diseases; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Death; Ventricular Dysfunction; Death, Sudden, Cardiac; Cardiac Output, Low
• Other Study ID Numbers: 06368