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

Primary Purpose

Coronary Heart Disease, Congestive Heart Failure, Ventricular Dysfunction

Status

Terminated

Phase

Not Applicable

Locations

Canada

Study Type

Interventional

Intervention

Optimized medical therapy

Implantable Cardioverter Defibrillator

About this trial

This is an interventional prevention trial for Coronary Heart Disease focused on measuring Implantable Cardioverter Defibrillator, Ejection Fraction, QRS duration

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Arm Label

Arm Description

Outcomes

Primary Outcome Measures

All-cause mortality

Secondary Outcome Measures

1. Presumed arrhythmic (sudden death) mortality. 2. Major morbidity which includes mortality, hospitalization and major device complications

Full Information

NCT ID

NCT00524862

First Posted

August 29, 2007

Last Updated

July 30, 2015

Sponsor

Unity Health Toronto

Collaborators

Institute for Clinical Evaluative Sciences, Ontario Ministry of Health and Long Term Care

1. Study Identification

Unique Protocol Identification Number

NCT00524862

Brief Title

Standard Drug Therapy vs. Implanted Defibrillator for Primary Prevention of Sudden Cardiac Death

Acronym

SMART-ICD

Official Title

Selective Strategy to Manage Arrhythmia Risk and Therapy With ICD

Study Type

Interventional

2. Study Status

Record Verification Date

July 2015

Overall Recruitment Status

Terminated

Why Stopped

Poor recruitment

Study Start Date

October 2007 (undefined)

Primary Completion Date

April 2011 (Actual)

Study Completion Date

April 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Unity Health Toronto

Collaborators

Institute for Clinical Evaluative Sciences, Ontario Ministry of Health and Long Term Care

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Coronary Heart Disease, Congestive Heart Failure, Ventricular Dysfunction, Low Cardiac Output, Sudden Cardiac Death

Keywords

Implantable Cardioverter Defibrillator, Ejection Fraction, QRS duration

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

5000 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Other

Arm Title

Arm Type

Other

Intervention Type

Drug

Intervention Name(s)

Optimized medical therapy

Intervention Description

Beta Blockers, ACE inhibitor or ARB, loop diuretics and/or spironolactone as appropriate, statin if indicated, aspirin and/or warfarin if indicated

Intervention Type

Device

Intervention Name(s)

Implantable Cardioverter Defibrillator

Other Intervention Name(s)

ICD

Intervention Description

an implanted device, called a defibrillator, which monitors heart rhythm and treats life-threatening rhythms accordingly

Primary Outcome Measure Information:

Title

All-cause mortality

Time Frame

minimum 1 year follow-up (maximum 6 year)

Secondary Outcome Measure Information:

Title

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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.

Overall Study Officials: