Recruiting

Genetic Stratification

Sponsor:

St. Joseph's Hospital and Medical Center, Phoenix

Code:

NCT05169840

Conditions

Coronary Artery Disease

Genetic Predisposition to Disease

Eligibility Criteria

Sex: All

Age: 40 - 60

Healthy Volunteers: Accepted

Interventions

Genetic Risk Score for Coronary Artery Disease

Study Details

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).

Conditions

Coronary Artery Disease

Genetic Predisposition to Disease

Study ID

NCT05169840

Start date

Aug 23, 2021

Status verified date

Feb, 2023

Completion date

Jun 15, 2024

Anticipated

Primary completion date

Jun 15, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 40 - 60

Healthy Volunteers: Accepted

Inclusion Criteria:

  • Males 40 to 60 years of age
  • Females 40 to 60 years of age
  • No known cardiovascular disease
  • Willing and able to sign consent

Exclusion Criteria:

  • Prisoners
  • Prior percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG)
  • Known ischemia on non-invasive testing
  • Ischemic cerebrovascular event
  • Peripheral arterial disease

Study Design

Enrollment

2000 participants

Anticipated

Interventions and Outcome Measures

Interventions

Genetic Risk Score for Coronary Artery Disease

Blood samples will be genotyped for million of genetic risk variants for Coronary Artery Disease (CAD)

Primary outcome measure

  • Genetic Risk Score (GRS) [ Time Frame: 2 years ]
  • Participant's response on the informed consent regarding their wish to learn about their genetic risk. [ Time Frame: 2 years ]
  • Spread of the Genetic Risk Score (GRS) in Hispanics or African Americans vs those of European descent. [ Time Frame: 2 years ]
  • Percentage of participants with a high Genetic Risk Score (GRS) who take action as a result. [ Time Frame: 10 years ]

Central Contacts and Locations

Central contacts

Locations

Chandler Regional Medical Center

Recruiting

Chandler, Arizona, United States, 85224

Contacts

Mercy Gilbert Medical Center

Recruiting

Gilbert, Arizona, United States, 85297

Contacts

St Joseph's Hospital and Medical Center

Recruiting

Phoenix, Arizona, United States, 85013

Contacts

Principal Investigator:

Robert Roberts, MD

More Information

Sponsor

St. Joseph's Hospital and Medical Center, Phoenix

Last update posted

Nov 24, 2023

Last verified

Feb, 2023

Keywords

  • Genetic Risk Score
  • Coronary Artery Disease

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by St. Joseph's Hospital and Medical Center, Phoenix on 2023-11-24.