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TerminatedNCT02958098Updated Mar 8, 2021

My Research Legacy Pilot Study

An observational study in Myocardial Infarction, Stroke and Cardiomyopathy, Dilated, sponsored by American Heart Association. Terminated. Open to participants aged 18 Years to 89 Years. Per ClinicalTrials.gov, last updated 2021-03-08.

Sponsored by American Heart Association · Observational

Why this study was terminated
Sponsor withdrew funding
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
2,267
Ages
18 Years to 89 Years
Sex
All
01

Study 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. 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

  1. 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.
  2. Day 90 Complete AHA's Life's Simple 7™ My Life Check v4.0 assessment; Start transmission from the Fitbit Charge 2.
  3. 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.
02

Conditions studied

  • 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
03

In context

Heart Failure

5,703 studies on the registry are indexed under Heart Failure; 1,220 are open to participants now.

This study's enrollment of 2,267 is above the median of 200 across 1,680 observational studies indexed under Heart Failure.

Browse Heart Failure studies →

Lead sponsor

American Heart Association is the lead sponsor of 12 studies on the registry; 6 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 89 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

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.

Inclusion criteria

  1. Age > or = to 18 years but \< 50 years.
  2. History of one (or more) of the following:

    1. Myocardial infarction
    2. Stroke
    3. Aortic dissection
    4. Systolic heart failure/cardiomyopathy
    5. Atrial fibrillation
  3. Individuals of any age > or = 18 years who don't have above medical conditions but want to participate in the study.
  4. Access to a computer and/or cell phone with internet access.

Exclusion criteria

Exclusion Criteria:

  1. Unwillingness to sign informed consent
  2. No access to a computer and/or cell phone with internet access.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
2,267 participants (actual)
Patient registry
No

Groups and cohorts

  • 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

06

What researchers measure

Primary outcomes

  1. study retention

    continues to engage with study after 6 months

    Time frame: 6 months

Secondary outcomes

  1. Change in answers to AHA's Life's Simple 7™ My Life Check v4.0

    answers to second and other surveys

    Time frame: 6 months

  2. Duration of time Fitbit Charge 2 used by participants

    recorded time

    Time frame: 6 months

  3. Change in Fitbit Charge 2 step count

    recorded steps

    Time frame: 6 months

  4. Percent of individuals that initiate but don't complete online process

    number that start but don't finish first surveys

    Time frame: 6 months

  5. Activity duration

    Daily, weekly, monthly activity from Fitbit Charge 2

    Time frame: 6 months

07

Study locations

No study locations are listed for this record.

08

References and documents

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 ↗

Individual participant data

Plan to share: No — Individual participant data will not be made available to other researchers.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 8, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02958098
Lead sponsor
American Heart Association
Responsible party
Sponsor
First posted
Nov 8, 2016
Start date
Nov 11, 2016
Primary completion
Oct 30, 2018
Completion
Oct 30, 2018
Last update
Mar 8, 2021

Study contacts

Jane A Leopold, MD
principal investigator · American Heart Association

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Mar 2021. You cannot join it, but the record below documents what was studied.

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