Ignite Creation Date:
2024-05-06 @ 3:46 PM
Last Modification Date:
2024-10-26 @ 1:57 PM
Study NCT ID:
NCT04755413
Status:
RECRUITING
Last Update Posted:
2023-10-26
First Post:
2021-02-11
Brief Title:
The Precision CAD Trial
Sponsor:
Emory University
Organization:
Emory University
Study Overview
Official Title:
Use of Biomarker Risk Score to Optimize Therapy in Patients With Coronary Artery Disease The Precision CAD Trial
Status:
RECRUITING
Status Verified Date:
2023-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
People with Coronary Artery Disease CAD have narrow or blocked arteries that supply blood to the heart Reduced blood flow to the heart muscle from CAD can cause chest pain or aching especially with exercise or activity CAD can lead to weakening of the heart muscle or heart failure and a higher risk of heart attack or death Certain proteins in the blood known as biomarkers can be found in people with CAD Higher levels of these biomarkers are associated with a greater risk of complications from CAD The purpose of this study is to see if a customized treatment based on biomarkers will reduce the biomarker levels and lead to lower risk of complications from CAD
Detailed Description:
People with Coronary Artery Disease CAD have narrow or blocked arteries that supply blood to the heart Reduced blood flow to the heart muscle from CAD can cause chest pain or aching especially with exercise or activity CAD can lead to weakening of the heart muscle or heart failure and a higher risk of heart attack or death Certain proteins in the blood known as biomarkers can be found in people with CAD Higher levels of these biomarkers are associated with a greater risk of complications from CAD The purpose of this study is to see if a customized treatment based on biomarkers will reduce the biomarker levels and lead to lower risk of complications from CAD
Participants with high biomarker levels will be randomly assigned like flipping a coin to either the treatment group or usual care Both groups will have physical exams blood tests and answer questionnaires Participants in the treatment group will have their medications adjusted based on their biomarker levels They will also be asked to make lifestyle changes like diet exercise and quitting smoking Participants in the usual care group will receive the standard of care prescribed by their doctor
This study will take place in research rooms at Emory University Hospital and the Woodruff Memorial Research Building
Participants will be paid for being in the study
Participants will be recruited from Emory Healthcare outpatient cardiology clinics and cath labs Participants will be identified through the medical record and by their doctors Written consent will be obtained from Participants before they can join the study
Study data and blood samples will be collected and banked for possible research in the future These may also be shared with other researchers including researchers outside of Emory
This study will advance scientific knowledge and benefit human health by giving us more treatment options for CAD
Participants with high biomarker levels will be randomly assigned like flipping a coin to either the treatment group or usual care Both groups will have physical exams blood tests and answer questionnaires Participants in the treatment group will have their medications adjusted based on their biomarker levels They will also be asked to make lifestyle changes like diet exercise and quitting smoking Participants in the usual care group will receive the standard of care prescribed by their doctor
This study will take place in research rooms at Emory University Hospital and the Woodruff Memorial Research Building
Participants will be paid for being in the study
Participants will be recruited from Emory Healthcare outpatient cardiology clinics and cath labs Participants will be identified through the medical record and by their doctors Written consent will be obtained from Participants before they can join the study
Study data and blood samples will be collected and banked for possible research in the future These may also be shared with other researchers including researchers outside of Emory
This study will advance scientific knowledge and benefit human health by giving us more treatment options for CAD
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None