Improving Cardiac Secondary Prevention
Sponsor
Western University, Canada (Other)
Overall Status
Unknown status
CT.gov ID
NCT03269708
Collaborator
(none)
200
1
2
18.1
11.1
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Study Type:
Interventional
Anticipated Enrollment
:
200 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Investigator, Outcomes Assessor)
Primary Purpose:
Prevention
Official Title:
Improving Cardiac Secondary Prevention Through Personalized Biomarker Knowledge
Anticipated Study Start Date
:
Mar 1, 2019
Anticipated Primary Completion Date
:
Sep 1, 2020
Anticipated Study Completion Date
:
Sep 1, 2020
Arms and Interventions
| 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
|
Outcome Measures
Primary Outcome Measures
- Exercise capacity based on cardiopulmonary exercise testing [after 6-month cardiac rehabilitation program]
Online VO2 maximum
Secondary Outcome Measures
- Adherence to supervised exercise sessions [6 months]
Proportion of prescribed supervised on-site exercise sessions attended
- Activity assessment [6 months]
Garmin recording
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
- 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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | London Health Sciences Centre, Western University | London | Ontario | Canada | N6A 5A5 |
Sponsors and Collaborators
- Western University, Canada
Investigators
- Principal Investigator: J. Geoffrey Pickering, MD PhD, Western Faculty
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Geoffrey Pickering MD PhD,
Professor,
Western University, Canada
ClinicalTrials.gov Identifier:
NCT03269708
Other Study ID Numbers:
- 109209
First Posted:
Sep 1, 2017
Last Update Posted:
Oct 26, 2018
Last Verified:
Oct 1, 2018
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms: