My Research Legacy Pilot Study

NCT02958098 | Terminated DMC

• 1 other identifier: My Research Legacy Pilot Study
• Study Type: observational
• Target: 2,267
• Locations: 0 countries
• Sites: N/A

Brief 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.

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

Outcome Measures

Primary Outcomes (1)

• study retention

  continues to engage with study after 6 months

  6 months

Secondary Outcomes (5)

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

  6 months

• Duration of time Fitbit Charge 2 used by participants

  6 months

• Change in Fitbit Charge 2 step count

  6 months

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

  6 months

• Activity duration

  6 months

Study Arms (5)

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

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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
• 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.

You may not qualify if:

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

Sponsors & Collaborators

• American Heart Association: lead

Related Publications (1)

• 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.

  PMID: 34649522 DERIVED

MeSH Terms

Conditions

Myocardial Infarction; Stroke; Cardiomyopathy, Dilated; Heart Failure, Systolic; Atrial Fibrillation; Aortic Dissection

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Cardiomegaly; Cardiomyopathies; Laminopathies; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Heart Failure; Arrhythmias, Cardiac; Dissection, Blood Vessel; Aneurysm; Acute Aortic Syndrome; Aortic Diseases

Study Officials

• Jane A Leopold, MD

  American Heart Association

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 4, 2016
• First Posted: November 8, 2016
• Study Start: November 11, 2016
• Primary Completion: October 30, 2018
• Study Completion: October 30, 2018
• Last Updated: March 8, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share