NCT03277365

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100,000

participants targeted

Target at P75+ for not_applicable

Timeline
52mo left

Started Sep 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress67%
Sep 2017Sep 2030

First Submitted

Initial submission to the registry

September 5, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 11, 2017

Completed
15 days until next milestone

Study Start

First participant enrolled

September 26, 2017

Completed
8.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 11, 2026

Completed
4.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2030

Expected
Last Updated

April 17, 2024

Status Verified

April 1, 2024

Enrollment Period

8.4 years

First QC Date

September 5, 2017

Last Update Submit

April 15, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Initiation of Statin Therapy

    Participant begins taking Statin as indicated by survey.

    6 months

Interventions

Risk scores are provided by ResearchKit app.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Under 18 years old

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Scripps Translational Science Institute

La Jolla, California, 92037, United States

RECRUITING

MeSH Terms

Conditions

Heart Diseases

Condition Hierarchy (Ancestors)

Cardiovascular Diseases

Central Study Contacts

Jennifer Wagner, RN

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director, Genomics

Study Record Dates

First Submitted

September 5, 2017

First Posted

September 11, 2017

Study Start

September 26, 2017

Primary Completion

February 11, 2026

Study Completion (Estimated)

September 1, 2030

Last Updated

April 17, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will not share

Individual participant data will not be shared.

Locations