Genetic Risk Stratification for Primary Prevention of CAD in Men and Pre & Post-menopausal Women
NCT ID: NCT05169840
Last Updated: 2023-11-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
2000 participants
OBSERVATIONAL
2021-08-23
2024-06-15
Brief Summary
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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).
Detailed Description
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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 CLIA-approved laboratories.
The derived GRS will be added to the conventional risk score using the American College of Cardiology/American Heart Association's (AHA) Pooled Cohort Atherosclerotic Cardiovascular Disease (ASCVD) Risk Equation. In the female cohort, investigators will also be screening for female-specific risk factors that have been added to the ACC/AHA 2018 Blood Cholesterol Guidelines to be used as risk enhancers. Everyone at high risk, will be referred to their physician for further management and given the opportunity for genetic counseling by a member of the research team. Completion of the 2 year recruitment will meet the objectives, however, an annual follow-up will be obtained by electronic survey via REDCap, letter or phone call over a 10 year period as it may provide information on long term genetic prediction.
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). The investigators expect to complete recruitment in two years and prove that the GRS is appropriate for clinical application and can detect individuals that have a 50% or more increase in risk for CAD.
Conditions
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Study Design
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OTHER
PROSPECTIVE
Interventions
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Genetic Risk Score for Coronary Artery Disease
Blood samples will be genotyped for million of genetic risk variants for Coronary Artery Disease (CAD)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Females 40 to 60 years of age
* No known cardiovascular disease
* Willing and able to sign consent
Exclusion Criteria
* Prior percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG)
* Known ischemia on non-invasive testing
* Ischemic cerebrovascular event
* Peripheral arterial disease
40 Years
60 Years
ALL
Yes
Sponsors
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Chandler Regional Medical Center
UNKNOWN
Mercy Gilbert Medical Center
UNKNOWN
St. Joseph's Hospital and Medical Center, Phoenix
OTHER
Responsible Party
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Principal Investigators
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Robert Roberts, MD
Role: PRINCIPAL_INVESTIGATOR
Dignity Health
Locations
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Chandler Regional Medical Center
Chandler, Arizona, United States
Mercy Gilbert Medical Center
Gilbert, Arizona, United States
St Joseph's Hospital and Medical Center
Phoenix, Arizona, United States
Countries
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Central Contacts
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Facility Contacts
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Jennine Zumbuhl, RN, MSHA
Role: backup
Other Identifiers
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19-500-384-50-17
Identifier Type: -
Identifier Source: org_study_id