NCT01248702

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
600

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2012

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 22, 2010

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 25, 2010

Completed
1.4 years until next milestone

Study Start

First participant enrolled

April 1, 2012

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2012

Completed
Last Updated

March 7, 2012

Status Verified

March 1, 2012

Enrollment Period

1 month

First QC Date

November 22, 2010

Last Update Submit

March 6, 2012

Conditions

Keywords

Myocardial InfarctionHeart FailureSudden Cardiac DeathCritical Pathways

Outcome Measures

Primary Outcomes (1)

  • Rate of Referral for ICD Assessment

    1 year

Secondary Outcomes (1)

  • Rate of ICD Implantation

    1 year

Study Arms (2)

Critical Pathway

EXPERIMENTAL
Other: Use of the ICD Critical Pathway

Standard Practice

NO INTERVENTION

Interventions

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.

Also known as: ICD Critical Pathway
Critical Pathway

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • patients with heart disease or a comorbid illness who have a documented life expectancy of less than 1 year

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St. Paul's Hospital

Vancouver, British Columbia, V6Z 1Y6, Canada

Location

MeSH Terms

Conditions

Myocardial InfarctionHeart FailureDeath, Sudden, Cardiac

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosisHeart ArrestDeath, SuddenDeath

Study Officials

  • S Cowan, MD, MSc

    St. Paul's Hospital, Vancouver, British Columbia

    STUDY DIRECTOR
  • A Ignaszewski, MD

    St. Paul's Hospital, Vancouver, British Columbia

    STUDY DIRECTOR
  • C Kerr, MD

    St. Paul's Hospital, Vancouver, British Columbia

    PRINCIPAL INVESTIGATOR
  • S Tung, MD

    St. Paul's Hospital, Vancouver, British Columbia

    STUDY DIRECTOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 22, 2010

First Posted

November 25, 2010

Study Start

April 1, 2012

Primary Completion

May 1, 2012

Study Completion

May 1, 2012

Last Updated

March 7, 2012

Record last verified: 2012-03

Locations