Myocardial InfarctionNCT02958098
My Research Legacy Pilot Study
An observational study of Myocardial Infarction and Stroke, run by American Heart Association.
Trial summary
The My Research Legacy Pilot Study will establish a participant registry that collects self-reported health data and answers to online survey questions about individual daily choices, diets, and exercise; data from wearable devices; and, (optional) data from genome sequencing analysis. Read more about this study
- Who is it for?
- Ages 18 to 89 years
- Conditions the study is for
- Myocardial Infarction, Stroke, Cardiomyopathy, Dilated
- How many people
- 2,267 participants
- Where
- No sites listed yet
- Study dates
- 11 Nov 2016to 30 Oct 2018
- Phase
- Observational
- 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 to 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All individuals equal to or older than 18 years but younger than 50 years of age who have a history of, or have, an aortic dissection; or systolic heart failure/cardiomyopathy; or atrial fibrillation; or myocardial infarction; or stroke. All other individuals equal to or older than 18 years who don't meet the above health criteria but are interested in the study.
Who may be able to join
- Age > or = to 18 years but < 50 years.
- History of one (or more) of the following:
- Myocardial infarction
- Stroke
- Aortic dissection
- Systolic heart failure/cardiomyopathy
Show all 9Show fewer
- Atrial fibrillation
- Individuals of any age > or = 18 years who don't have above medical conditions but want to participate in the study.
- Access to a computer and/or cell phone with internet access.
Who cannot join
- Unwillingness to sign informed consent
- No access to a computer and/or cell phone with internet access.
About this study
The My Research Legacy Pilot Study will establish a participant registry that collects self-reported health data and answers to online survey questions about individual daily choices, diets, and exercise; data from wearable devices; and, (optional) data from genome sequencing analysis. Individuals under the age of 50 who meet eligibility criteria will answer questions using the American Heart Association's (AHA) Life's Simple 7™ My Life Check v4.0 three times over the course of 6 months and transmit data from a Fitbit Charge 2 device. All other individuals who are interested in the study and meet entry criteria may also enroll.
Read the detailed description
2,000 Participant My Research Legacy Pilot Study
- Day 0 - Enroll online, complete AHA's Life's Simple 7™ Survey Prospective participants will enroll in the research initiative via the My Research Legacy website (MyResearchLegacy.org). They will go through an online process in which they will answer brief, pre-qualifying questions before consenting to participate in the study.
- Participants will attest to their age and US residence, and will provide a self-reported diagnosis of cardiovascular disease (myocardial infarction, atrial fibrillation, aortic dissection, systolic congestive heart failure/cardiomyopathy) and/or stroke.
- Eligible participants will read and sign an online consent form.
- Within the participant console, the participants will answer AHA's Life's Simple 7™ My Life Check v4.0 assessment.
- Participants will be asked during the consent process if they will consent to provide medical records relevant to their diagnosis.
- Day 90 Complete AHA's Life's Simple 7™ My Life Check v4.0 assessment; Start transmission from the Fitbit Charge 2.
- Online Survey and contact Day 180 after enrollment, participants will receive an email requesting that they visit the participant console to repeat AHA's Life's Simple 7™ My Life Check v4.0 survey. Participants also have the option of determining whether or not they want to be contacted for future studies.
- Conditions
- Myocardial Infarction, Stroke, Cardiomyopathy, Dilated, Systolic Heart Failure, Atrial Fibrillation, Aortic Dissection
- Keywords
- myocardial infarction, stroke, dilated cardiomyopathy, systolic heart failure, atrial fibrillation, aortic dissection, wearable devices, genomic sequencing
- Medical subject headings
- Myocardial Infarction, Stroke, Cardiomyopathy, Dilated, Heart Failure, Systolic, Atrial Fibrillation, Aortic Dissection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Myocardial infarction | Individuals with myocardial infarction before age 50 years. | |
| Stroke | Individuals with stroke before age 50 years | |
| Aortic dissection | Individuals with aortic dissection before age 50 years | |
| Systolic heart failure | Individuals with systolic heart failure/dilated cardiomyopathy before age 50 years. | |
| Atrial fibrillation | Individuals with atrial fibrillation before age 50 years |
What is being measured
The primary outcome is the main question the study is designed to answer.
study retention
continues to engage with study after 6 months
Measured: 6 months
Secondary outcomes (5)
Change in answers to AHA's Life's Simple 7™ My Life Check v4.0
answers to second and other surveys
Measured: 6 months
Duration of time Fitbit Charge 2 used by participants
recorded time
Measured: 6 months
Change in Fitbit Charge 2 step count
recorded steps
Measured: 6 months
Percent of individuals that initiate but don't complete online process
number that start but don't finish first surveys
Measured: 6 months
Activity duration
Daily, weekly, monthly activity from Fitbit Charge 2
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 posted8 Nov 2016 (estimated)
- Study start11 Nov 2016
- Primary completion30 Oct 2018
- Study completion30 Oct 2018
Why it stopped: Sponsor withdrew funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,267 participants (actual)
Sponsor and investigators
- Lead sponsor
- American Heart Association
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jane A Leopold, MD, Principal investigator, American Heart Association
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02958098
- Sponsor's protocol ID
- My Research Legacy Pilot Study
- Status last verified
- Mar 2021
- First submitted
- 4 Nov 2016
- Last updated
- 8 Mar 2021
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No: Individual participant data will not be made available to other researchers.
Publications
Leopold JA, Antman EM. Digital health device measured sleep duration and ideal cardiovascular health: an observational study. BMC Cardiovasc Disord. 2021 Oct 14;21(1):497. doi: 10.1186/s12872-021-02284-z.
PubMed 34649522
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- My Research Legacy Pilot Study
- ClinicalTrials.gov ID
- NCT02958098
- Acronym / sponsor ID
- My Research Legacy Pilot Study
- Conditions
- Myocardial Infarction, Stroke, Cardiomyopathy, Dilated, Systolic Heart Failure, Atrial Fibrillation, Aortic Dissection
- Keywords
- myocardial infarction, stroke, dilated cardiomyopathy, systolic heart failure, atrial fibrillation, aortic dissection, wearable devices, genomic sequencing
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Sponsor withdrew funding
- Enrolment
- 2,267 participants (actual)
- Lead sponsor
- American Heart AssociationUniversity, hospital or other
- Study start
- 11 Nov 2016 (actual)
- Primary completion
- 30 Oct 2018 (actual)
- Study completion
- 30 Oct 2018 (actual)
- First posted
- 8 Nov 2016 (estimated)
- 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 My Research Legacy Pilot Study will establish a participant registry that collects self-reported health data and answers to online survey questions about individual daily choices, diets, and exercise; data from wearable devices; and, (optional) data from genome sequencing analysis. Individuals under the age of 50 who meet eligibility criteria will answer questions using the American Heart Association's (AHA) Life's Simple 7™ My Life Check v4.0 three times over the course of 6 months and transmit data from a Fitbit Charge 2 device. All other individuals who are interested in the study and meet entry criteria may also enroll.
Detailed description
2,000 Participant My Research Legacy Pilot Study
- Day 0 - Enroll online, complete AHA's Life's Simple 7™ Survey Prospective participants will enroll in the research initiative via the My Research Legacy website (MyResearchLegacy.org). They will go through an online process in which they will answer brief, pre-qualifying questions before consenting to participate in the study.
- Participants will attest to their age and US residence, and will provide a self-reported diagnosis of cardiovascular disease (myocardial infarction, atrial fibrillation, aortic dissection, systolic congestive heart failure/cardiomyopathy) and/or stroke.
- Eligible participants will read and sign an online consent form.
- Within the participant console, the participants will answer AHA's Life's Simple 7™ My Life Check v4.0 assessment.
- Participants will be asked during the consent process if they will consent to provide medical records relevant to their diagnosis.
- Day 90 Complete AHA's Life's Simple 7™ My Life Check v4.0 assessment; Start transmission from the Fitbit Charge 2.
- Online Survey and contact Day 180 after enrollment, participants will receive an email requesting that they visit the participant console to repeat AHA's Life's Simple 7™ My Life Check v4.0 survey. Participants also have the option of determining whether or not they want to be contacted for future studies.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Myocardial infarction | – | –Individuals with myocardial infarction before age 50 years. |
| Stroke | – | –Individuals with stroke before age 50 years |
| Aortic dissection | – | –Individuals with aortic dissection before age 50 years |
| Systolic heart failure | – | –Individuals with systolic heart failure/dilated cardiomyopathy before age 50 years. |
| Atrial fibrillation | – | –Individuals with atrial fibrillation before age 50 years |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All individuals equal to or older than 18 years but younger than 50 years of age who have a history of, or have, an aortic dissection; or systolic heart failure/cardiomyopathy; or atrial fibrillation; or myocardial infarction; or stroke. All other individuals equal to or older than 18 years who don't meet the above health criteria but are interested in the study.
Key inclusion criteria (9 listed)
- Age > or = to 18 years but < 50 years.
- History of one (or more) of the following:
- Individuals of any age > or = 18 years who don't have above medical conditions but want to participate in the study.
- Access to a computer and/or cell phone with internet access.
Key exclusion criteria (2 listed)
- Unwillingness to sign informed consent
- No access to a computer and/or cell phone with internet access.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
study retention
Time frame: 6 months
continues to engage with study after 6 months
5 secondary outcomes
Change in answers to AHA's Life's Simple 7™ My Life Check v4.0
Time frame: 6 months
Duration of time Fitbit Charge 2 used by participants
Time frame: 6 months
Change in Fitbit Charge 2 step count
Time frame: 6 months
Percent of individuals that initiate but don't complete online process
Time frame: 6 months
Activity duration
Time frame: 6 months
Results and safety
The study was stopped early (reason given: Sponsor withdrew funding). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2021.
- Derived from this study: PubMed 34649522Leopold JA, Antman EM. Digital health device measured sleep duration and ideal cardiovascular health: an observational study. BMC Cardiovasc Disord. 2021 Oct 14;21(1):497. doi: 10.1186/s12872-021-02284-z.
- Individual participant dataSharing planned: No. Individual participant data will not be made available to other researchers.
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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.
Jane A Leopold, MD principal investigator
American Heart Association
Questions about this trial
What is this clinical trial studying?
An observational study of Myocardial Infarction and Stroke, run by American Heart Association.
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 9 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: stopped early, as of the sponsor's last update on 8 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
The study was stopped early (reason given: Sponsor withdrew funding). 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?
study retention (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02958098, which also lists 1 linked publication.
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 8 Mar 2021.