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Improving Cardiac Secondary Prevention

Primary Purpose

Myocardial Infarction, Secondary Prevention

Status
Unknown status
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Education regarding telomere length
Sponsored by
Western University, Canada
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Myocardial Infarction

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

1. Individuals who have sustained a myocardial infarction and entered the cardiac rehabilitation program

Exclusion Criteria:

  1. Individuals with genetic mutations that affect telomere length
  2. Individuals who may not have the mental capacity to understanding the ramifications of risk biomarkers

Sites / Locations

  • London Health Sciences Centre, Western University

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control

Knowledge transfer group

Arm Description

Participants receive standard care in cardiac rehabilitation program

Participants receive standard care in cardiac rehabilitation program plus education regarding telomere length

Outcomes

Primary Outcome Measures

Exercise capacity based on cardiopulmonary exercise testing
Online VO2 maximum

Secondary Outcome Measures

Adherence to supervised exercise sessions
Proportion of prescribed supervised on-site exercise sessions attended
Activity assessment
Garmin recording

Full Information

First Posted
August 30, 2017
Last Updated
October 25, 2018
Sponsor
Western University, Canada
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1. Study Identification

Unique Protocol Identification Number
NCT03269708
Brief Title
Improving Cardiac Secondary Prevention
Official Title
Improving Cardiac Secondary Prevention Through Personalized Biomarker Knowledge
Study Type
Interventional

2. Study Status

Record Verification Date
October 2018
Overall Recruitment Status
Unknown status
Study Start Date
March 2019 (Anticipated)
Primary Completion Date
September 2020 (Anticipated)
Study Completion Date
September 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Western University, Canada

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to determine whether providing individuals with personalized information on cellular aging, including telomere dynamics, will stimulate them to adhere to cardiac prevention strategies and improve exercise capacity.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myocardial Infarction, Secondary Prevention

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
No Intervention
Arm Description
Participants receive standard care in cardiac rehabilitation program
Arm Title
Knowledge transfer group
Arm Type
Experimental
Arm Description
Participants receive standard care in cardiac rehabilitation program plus education regarding telomere length
Intervention Type
Behavioral
Intervention Name(s)
Education regarding telomere length
Intervention Description
Teaching concepts of cellular aging and telomere length
Primary Outcome Measure Information:
Title
Exercise capacity based on cardiopulmonary exercise testing
Description
Online VO2 maximum
Time Frame
after 6-month cardiac rehabilitation program
Secondary Outcome Measure Information:
Title
Adherence to supervised exercise sessions
Description
Proportion of prescribed supervised on-site exercise sessions attended
Time Frame
6 months
Title
Activity assessment
Description
Garmin recording
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 1. Individuals who have sustained a myocardial infarction and entered the cardiac rehabilitation program Exclusion Criteria: Individuals with genetic mutations that affect telomere length Individuals who may not have the mental capacity to understanding the ramifications of risk biomarkers
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
J. Geoffrey Pickering, MD PhD
Phone
519-663-3973
Ext
33973
Email
gpickering@robarts.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Tim Hartley, MSc
Phone
(519) 646-6100
Ext
x36570
Email
tim.hartley@lhsc.on.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
J. Geoffrey Pickering, MD PhD
Organizational Affiliation
Western Faculty
Official's Role
Principal Investigator
Facility Information:
Facility Name
London Health Sciences Centre, Western University
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 5A5
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No

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Improving Cardiac Secondary Prevention

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