Genetic Risk Stratification for Primary Prevention of CAD in Men and Pre & Post-menopausal Women
1 other identifier
observational
2,000
1 country
3
Brief Summary
The investigators propose to genotype males and females at age 40 years and older, who are asymptomatic and without known heart disease (N=2000). DNA from a blood sample will be genotyped for millions of genetic risk variants for CAD by Baylor College of Medicine Human Genome Sequencing Center Clinical Laboratory (HGSC-CL) in a CLIA-approved laboratory. The overall objective after 2 years is to determine if genetic screening for risk of CAD in asymptomatic men and women has the discriminatory power to detect those at highest risk who would potentially benefit most from appropriate primary prevention. It will also determine whether the GRS is appropriate for different ethnic and race groups such as Hispanics, African Americans and Whites, and to what extent those individuals knowing that they are at higher risk, are more likely to seek further advice on management of the risks (either through changes in lifestyle or therapy).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Aug 2021
Typical duration for all trials
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 13, 2021
CompletedStudy Start
First participant enrolled
August 23, 2021
CompletedFirst Posted
Study publicly available on registry
December 27, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 15, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
June 15, 2024
CompletedNovember 24, 2023
February 1, 2023
2.8 years
May 13, 2021
November 22, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Genetic Risk Score (GRS)
The GRS will be calculated by summing the product of the number of risk variants inherited by each individual times their associated Coronary Artery Disease risk. The score will be classified into low, intermediate and high.
2 years
Participant's response on the informed consent regarding their wish to learn about their genetic risk.
Participants will be asked on the informed consent whether they would like to learn about their calculated genetic risk and will provide a yes or no answer.
2 years
Spread of the Genetic Risk Score (GRS) in Hispanics or African Americans vs those of European descent.
Since previous studies utilizing the GRS have been predominately in white individuals of European descent data will be stratified to determine if the GRS has the same risk stratification power in Hispanics and African Americans vs those of European descent.
2 years
Percentage of participants with a high Genetic Risk Score (GRS) who take action as a result.
Participants with a high GRS will be asked at follow up whether they have followed through on recommendations to seek further care, started any new therapies and/or if they have made lifestyle changes as a result. This will be assessed annually for 10 years.
10 years
Interventions
Blood samples will be genotyped for million of genetic risk variants for Coronary Artery Disease (CAD)
Eligibility Criteria
People 40 to 60 years old who are asymptomatic and without known heart disease.
You may qualify if:
- Males 40 to 60 years of age
- Females 40 to 60 years of age
- No known cardiovascular disease
- Willing and able to sign consent
You may not qualify if:
- Prisoners
- Prior percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG)
- Known ischemia on non-invasive testing
- Ischemic cerebrovascular event
- Peripheral arterial disease
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- St. Joseph's Hospital and Medical Center, Phoenixlead
- Chandler Regional Medical Centercollaborator
- Mercy Gilbert Medical Centercollaborator
Study Sites (3)
Chandler Regional Medical Center
Chandler, Arizona, 85224, United States
Mercy Gilbert Medical Center
Gilbert, Arizona, 85297, United States
St Joseph's Hospital and Medical Center
Phoenix, Arizona, 85013, United States
Biospecimen
Blood sample collected in a PAXgene tube
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Robert Roberts, MD
Dignity Health
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 13, 2021
First Posted
December 27, 2021
Study Start
August 23, 2021
Primary Completion
June 15, 2024
Study Completion
June 15, 2024
Last Updated
November 24, 2023
Record last verified: 2023-02
Data Sharing
- IPD Sharing
- Will not share