A Critical Pathway for Implantable Cardioverter-Defibrill... | NCT01248702

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

NCT01248702

Sponsor

University of British Columbia

Status

Unknown status

Last Update Posted

Mar 7, 2012Estimated

Enrollment

600Estimated

Phase

Not Applicable

Conditions

Myocardial Infarction
Heart Failure

Interventions

Use of the ICD Critical Pathway

Countries

Canada

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2012

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2012

Primary Completion Date

May 2012Estimated

Completion Date

May 2012Estimated

First Submitted Date

Nov 22, 2010

First Submission Date that Met QC Criteria

Nov 23, 2010

First Posted Date

Nov 25, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 6, 2012

Last Update Posted Date

Mar 7, 2012Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

600Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Critical Pathway	Experimental		Other: Use of the ICD Critical Pathway
Standard Practice	No Intervention

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Use of the ICD Critical Pathway	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.

Measure	Description	Time Frame
Rate of Referral for ICD Assessment		1 year

Measure	Description	Time Frame
Rate of ICD Implantation		1 year

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
S Cowan, MD, MSc	Contact	(604) 682 2344		capture.study@gmail.com

Overall Officials

Name	Affiliation	Role
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

Locations

Facility	Status	City	State	ZIP	Country	Contacts
St. Paul's Hospital		Vancouver	British Columbia	V6Z 1Y6	Canada

Condition Browse Module

MeSH Terms

ID	Term
D009203	Myocardial Infarction
D006333	Heart Failure
D016757	Death, Sudden, Cardiac

Ancestor Terms

ID	Term
D017202	Myocardial Ischemia
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D014652	Vascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided