MyGeneRank: A Digital Platform for Next-Generation Genetic Studies

Heart Diseases Clinical Trial

Official title:

MyGeneRank: A Digital Platform for Next-Generation Genetic Studies

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03277365
• Other study ID #: 16-6835
• Status: Recruiting
• Phase: N/A
• Start date: September 26, 2017
• Est. completion date: September 2030

Study information

• Verified date: April 2024
• Source: Scripps Translational Science Institute
• Contact: Jennifer Wagner, RN
• Phone: 858-784-2028
• Email: generank[@]scripps.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100000
• Est. completion date: September 2030
• Est. primary completion date: February 11, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Customer of 23andMe willing to share their 23andMe data

• User of Apple mobile device

Exclusion Criteria:

• Under 18 years old

Related Conditions & MeSH terms

• Heart Diseases

Intervention

Other:
• Receive genetic risk information
Risk scores are provided by ResearchKit app.

Locations

Country	Name	City	State
United States	Scripps Translational Science Institute	La Jolla	California

Sponsors (1)

Lead Sponsor	Collaborator
Scripps Translational Science Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Initiation of Statin Therapy	Participant begins taking Statin as indicated by survey.	6 months