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

Heart Failure Clinical Trial

— CAPTURE  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01248702
• Other study ID #: H10-01537
• Status: Not yet recruiting
• Phase: N/A
• First received: November 22, 2010
• Last updated: March 6, 2012
• Start date: April 2012
• Est. completion date: May 2012

Study information

• Verified date: March 2012
• Source: University of British Columbia
• Contact: S Cowan, MD, MSc
• Phone: (604) 682 2344
• Email: capture.study[@]gmail.com
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 600
• Est. completion date: May 2012
• Est. primary completion date: May 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Cardiomyopathies
• Heart Failure
• Infarction
• Myocardial Infarction

Intervention

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.

Locations

Country	Name	City	State
Canada	St. Paul's Hospital	Vancouver	British Columbia

Sponsors (1)

Lead Sponsor	Collaborator
University of British Columbia

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of Referral for ICD Assessment		1 year	No
Secondary	Rate of ICD Implantation		1 year	No