A Critical Pathway for Implantable Cardioverter-Defibrillators in Patients With Ischemic Cardiomyopathy

NCT ID: NCT01248702

Last Updated: 2012-03-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

600 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-04-30

Study Completion Date

2012-05-31

Brief Summary

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The purpose of this study is to develop and implement a critical pathway to identify patients with ischemic cardiomyopathy who are candidates for an implantable cardioverter-defibrillator (ICD). This study will also determine whether the use of the critical pathway for ICDs is associated with a change in the ICD referral and implantation rate.

Detailed Description

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Despite improvements in both medical management and revascularization strategies, sudden death is still a significant complication in patients with ischemic cardiomyopathy. There is strong evidence to support the role of ICDs for the primary prevention of sudden death in this population. However, in Canada and the United States, ICDs are underutilized.

Critical pathways are algorithms that improve health care delivery and clinical outcomes while reducing practice variability. The use of a critical pathway to assess a patient's eligibility for an ICD may increase the appropriate use of this evidence-based technology.

Conditions

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Myocardial Infarction Heart Failure

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Critical Pathway

Group Type EXPERIMENTAL

Use of the ICD Critical Pathway

Intervention Type OTHER

The critical pathway is a series of predetermined processes designed to assess a patient's eligibility for an ICD. The critical pathway will incorporate current evidence-based practice guidelines.

Standard Practice

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Use of the ICD Critical Pathway

The critical pathway is a series of predetermined processes designed to assess a patient's eligibility for an ICD. The critical pathway will incorporate current evidence-based practice guidelines.

Intervention Type OTHER

Other Intervention Names

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ICD Critical Pathway

Eligibility Criteria

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Inclusion Criteria

* acute ST segment elevation myocardial infarction (STEMI)
* candidate for percutaneous revascularization
* permanent residents of British Columbia, Canada

Exclusion Criteria

* patients with heart disease or a comorbid illness who have a documented life expectancy of less than 1 year
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of British Columbia

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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S Cowan, MD, MSc

Role: STUDY_DIRECTOR

St. Paul's Hospital, Vancouver, British Columbia

A Ignaszewski, MD

Role: STUDY_DIRECTOR

St. Paul's Hospital, Vancouver, British Columbia

C Kerr, MD

Role: PRINCIPAL_INVESTIGATOR

St. Paul's Hospital, Vancouver, British Columbia

S Tung, MD

Role: STUDY_DIRECTOR

St. Paul's Hospital, Vancouver, British Columbia

Locations

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St. Paul's Hospital

Vancouver, British Columbia, Canada

Site Status

Countries

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Canada

Central Contacts

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S Cowan, MD, MSc

Role: CONTACT

(604) 682 2344

Facility Contacts

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S Cowan, MD, MSc

Role: primary

(604) 682 2344

Other Identifiers

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H10-01537

Identifier Type: -

Identifier Source: org_study_id

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