Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06542432
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-03-29
Brief Title:
Utility and Effectiveness of Polygenic Risk Scoring PRS for Coronary Artery Disease CAD
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Prospective Observational Trial to Assess Utility and Effectiveness of Polygenic Risk Scoring PRS in Participants at Risk for Coronary Artery Disease CAD
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this study is to assess the benefit to physicians and patients of adding an integrated risk score IRS to existing coronary artery risk tools by conducting a randomized prospective study IRS combines both an individuals coronary artery disease CAD polygenic risk score PRS and clinical risk factors like cholesterol levels and age This study will examine to what extent IRS knowledge impacts physicianprovider behavior as well as clinical outcomes including cholesterol levels and incident heart disease
Detailed Description:
This is a 11 randomized controlled trial of participants with no known coronary artery disease are not on lipid-lowering therapy and do not have LDL-C over 190mgdL Participants will be recruited from cohorts that have been previously genotyped and found to have either elevated or average risk based on a CAD IRS Participants will be randomized into two equal groups one group will receive their IRS result for coronary artery disease at baseline and the other group will receive their ASCVD Pooled Cohorts Equation result at baseline and CAD IRS result approximately 3 years after enrollment Subject data will be collected for 5 years from the time of enrollment
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None