Recruiting

Genetic Studies

Sponsor:

Scripps Translational Science Institute

Code:

NCT03277365

Conditions

Heart Diseases

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Receive genetic risk information

Study Details

Brief summary:

Many conditions affecting health are caused by a combination of environment, behaviors, and genes. While individuals can alter some factors in their lives to reduce the chances of developing different diseases (e.g., not smoking cigarettes), the contribution from genetic risk encoded by DNA remains with people throughout their lives. Scientists are still trying to determine the entirety of genetic factors that influence disease, but for some conditions it has been shown that the factors identified thus far can begin to identify people at high to low genetic risk. Looking across the genome, scientists can calculate a cumulative genetic risk score - which can be used to rank genetic risk compared to other worldwide populations.

The goal of this study is to determine how genetic risk influences health decisions and other things that can be controlled in life. The first genetic risk score is calculated for coronary heart disease (CAD). CAD ultimately leads to heart attacks, heart failure and sometimes sudden cardiac death and is the main reason heart disease remains as the number one cause of death worldwide. Other researchers have shown that this genetic risk score can be used to identify people with low, intermediate, and high risk for coronary heart disease. It has also been shown that the use of statins (cholesterol lowering drugs) provides greater benefit and protection against heart attack for people with high genetic risk for coronary artery disease.

Leveraging the Apple ResearchKit and the ResearchKit linked 23andMe API, customers of 23andMe are able to provide researchers access to their genomic data. Participants will use the ResearchKit app to provide consent, view study information, answer surveys, and contact the study team.

Participants will be asked to complete 3 surveys. One before viewing genetic risk scores, one immediately after viewing scores, and one 6 months after viewing scores.

Conditions

Heart Diseases

Study ID

NCT03277365

Start date

Sep 26, 2017

Status verified date

Apr, 2024

Completion date

Sep, 2030

Anticipated

Primary completion date

Feb 11, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • Customer of 23andMe willing to share their 23andMe data
  • User of Apple mobile device

Exclusion Criteria:

  • Under 18 years old

Study Design

Enrollment

100000 participants

Anticipated

Intervention Model

Single group

Primary purpose

Other

Interventions and Outcome Measures

Interventions

Receive genetic risk information

Risk scores are provided by ResearchKit app.

Primary outcome measure

  • Initiation of Statin Therapy [ Time Frame: 6 months ]

Central Contacts and Locations

Central contacts

Locations

Scripps Translational Science Institute

Recruiting

La Jolla, California, United States, 92037

Contacts

Emily Spencer, PhD

generank@scripps.edu

More Information

Sponsor

Scripps Translational Science Institute

Last update posted

Apr 17, 2024

Last verified

Apr, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Scripps Translational Science Institute on 2024-04-17.