NCT03269708

Brief Summary

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.

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 30, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 1, 2017

Completed
1.5 years until next milestone

Study Start

First participant enrolled

March 1, 2019

Completed
5.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2024

Completed
Last Updated

May 7, 2024

Status Verified

May 1, 2024

Enrollment Period

5.5 years

First QC Date

August 30, 2017

Last Update Submit

May 3, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Exercise capacity based on cardiopulmonary exercise testing

    Online VO2 maximum

    after 6-month cardiac rehabilitation program

Secondary Outcomes (2)

  • Adherence to supervised exercise sessions

    6 months

  • Activity assessment

    6 months

Study Arms (2)

Control

NO INTERVENTION

Participants receive standard care in cardiac rehabilitation program

Knowledge transfer group

EXPERIMENTAL

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

Behavioral: Education regarding telomere length

Interventions

Teaching concepts of cellular aging and telomere length

Knowledge transfer group

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

London Health Sciences Centre, Western University

London, Ontario, N6A 5A5, Canada

Location

MeSH Terms

Conditions

Myocardial Infarction

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Study Officials

  • J. Geoffrey Pickering, MD PhD

    Western Faculty

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

August 30, 2017

First Posted

September 1, 2017

Study Start

March 1, 2019

Primary Completion

September 1, 2024

Study Completion

September 1, 2024

Last Updated

May 7, 2024

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will not share

Locations