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

Sponsor

University of British Columbia (Other)

Overall Status

Unknown status

CT.gov ID

NCT01248702

Collaborator

(none)

600

Enrollment

Location

Arms

Duration (Days)

608.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Myocardial Infarction Heart Failure	Other: Use of the ICD Critical Pathway	N/A

Detailed Description

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

600 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Health Services Research

Official Title:

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

Study Start Date :

Apr 1, 2012

Anticipated Primary Completion Date :

May 1, 2012

Anticipated Study Completion Date :

May 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Critical Pathway	Other: 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. Other Names: ICD Critical Pathway
No Intervention: Standard Practice

Arm

Intervention/Treatment

Experimental: Critical Pathway

Other: 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.

Other Names:

ICD Critical Pathway

No Intervention: Standard Practice

Outcome Measures

Primary Outcome Measures

Rate of Referral for ICD Assessment [1 year]

Secondary Outcome Measures

Rate of ICD Implantation [1 year]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	St. Paul's Hospital	Vancouver	British Columbia	Canada	V6Z 1Y6

Sponsors and Collaborators

University of British Columbia

Investigators

Study Director: S Cowan, MD, MSc, St. Paul's Hospital, Vancouver, British Columbia
Study Director: A Ignaszewski, MD, St. Paul's Hospital, Vancouver, British Columbia
Principal Investigator: C Kerr, MD, St. Paul's Hospital, Vancouver, British Columbia
Study Director: S Tung, MD, St. Paul's Hospital, Vancouver, British Columbia