Myocardial InfarctionNCT03269708
Improving Cardiac Secondary Prevention
A study testing Education regarding telomere length in people with Myocardial Infarction and Secondary Prevention, run by Western University, Canada at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myocardial Infarction, Secondary Prevention
- What is being tested?
- Education regarding telomere length
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteCanada
- Study dates
- 1 Mar 2019to Sep 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. Individuals who have sustained a myocardial infarction and entered the cardiac rehabilitation program
Who cannot join
- Individuals with genetic mutations that affect telomere length
- Individuals who may not have the mental capacity to understanding the ramifications of risk biomarkers
Trial locations and contacts
1 site in 1 country.
Canada1 site
London Health Sciences Centre, Western University
London, Ontario, N6A 5A5
About this study
Official title: 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.
Read the 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.
- Conditions
- Myocardial Infarction, Secondary Prevention
- Being tested
- Education regarding telomere length
- Medical subject headings
- Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Education regarding telomere lengthBehavioural
Teaching concepts of cellular aging and telomere length
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Behavioral: Education regarding telomere length |
What is being measured
The primary outcome is the main question the study is designed to answer.
Exercise capacity based on cardiopulmonary exercise testing
Online VO2 maximum
Measured: after 6-month cardiac rehabilitation program
Secondary outcomes (2)
Adherence to supervised exercise sessions
Proportion of prescribed supervised on-site exercise sessions attended
Measured: 6 months
Activity assessment
Garmin recording
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2017
- Study start1 Mar 2019
- Primary completionSep 2024 (estimated)
- Study completionSep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myocardial InfarctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Western University, Canada
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Geoffrey Pickering MD PhD, Western University, Canada
- Investigators
- J. Geoffrey Pickering, MD PhD, Principal investigator, Western Faculty
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03269708
- Sponsor's protocol ID
- 109209
- Status last verified
- May 2024
- First submitted
- 30 Aug 2017
- Last updated
- 7 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Cardiac Secondary Prevention Through Personalized Biomarker Knowledge
- ClinicalTrials.gov ID
- NCT03269708
- Acronym / sponsor ID
- 109209
- Conditions
- Myocardial Infarction, Secondary Prevention
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Western University, CanadaUniversity, hospital or other
- Study start
- 1 Mar 2019 (actual)
- Primary completion
- Sep 2024 (estimated)
- Study completion
- Sep 2024 (estimated)
- First posted
- 1 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Participants receive standard care in cardiac rehabilitation program |
| Knowledge transfer group | Experimental | Behavioral: Education regarding telomere lengthParticipants receive standard care in cardiac rehabilitation program plus education regarding telomere length |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 1. Individuals who have sustained a myocardial infarction and entered the cardiac rehabilitation program
Key exclusion criteria (2 listed)
- Individuals with genetic mutations that affect telomere length
- Individuals who may not have the mental capacity to understanding the ramifications of risk biomarkers
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Education regarding telomere lengthTeaching concepts of cellular aging and telomere length | Behavioural | Knowledge transfer group |
Primary outcome
Exercise capacity based on cardiopulmonary exercise testing
Time frame: after 6-month cardiac rehabilitation program
Online VO2 maximum
2 secondary outcomes
Adherence to supervised exercise sessions
Time frame: 6 months
Activity assessment
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
J. Geoffrey Pickering, MD PhD principal investigator
Western Faculty
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Education regarding telomere length in people with Myocardial Infarction and Secondary Prevention, run by Western University, Canada at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Exercise capacity based on cardiopulmonary exercise testing (time frame: after 6-month cardiac rehabilitation program). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2024.