Improving Cardiac Secondary Prevention

May 3, 2024 updated by: Geoffrey Pickering MD PhD, Western University, Canada

Improving Cardiac Secondary Prevention Through Personalized Biomarker Knowledge

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

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

Individuals who have sustained a heart attack are at considerable risk for future cardiac events. A cardiac rehabilitation and exercise program can reduce this risk but it remains a challenge to adopt optimum lifestyle changes. We will determine whether providing individuals with information on leukocyte telomere length, will motivate them to improve their exercise performance. We will test whether professionally conveying this information will stimulate an individual to adhere to proven cardiac prevention strategies, looking at the extent to which one's exercise capacity improves over time.

Study Type

Interventional

Enrollment (Estimated)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • London, Ontario, Canada, N6A 5A5
        • London Health Sciences Centre, Western University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control
Participants receive standard care in cardiac rehabilitation program
Experimental: Knowledge transfer group
Participants receive standard care in cardiac rehabilitation program plus education regarding telomere length
Behavioral: Education regarding telomere length
Teaching concepts of cellular aging and telomere length

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Exercise capacity based on cardiopulmonary exercise testing
Time Frame: after 6-month cardiac rehabilitation program
Online VO2 maximum
after 6-month cardiac rehabilitation program

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adherence to supervised exercise sessions
Time Frame: 6 months
Proportion of prescribed supervised on-site exercise sessions attended
6 months
Activity assessment
Time Frame: 6 months
Garmin recording
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Western University, Canada

Investigators

  • Principal Investigator: J. Geoffrey Pickering, MD PhD, Western Faculty

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2019

Primary Completion (Estimated)

September 1, 2024

Study Completion (Estimated)

September 1, 2024

Study Registration Dates

First Submitted

August 30, 2017

First Submitted That Met QC Criteria

August 30, 2017

First Posted (Actual)

September 1, 2017

Study Record Updates

Last Update Posted (Actual)

May 7, 2024

Last Update Submitted That Met QC Criteria

May 3, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 109209

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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