The Precision CAD Trial

Phase

N/A

Condition

Hypercholesterolemia

Heart Disease

Chest Pain

Treatment

Standard of Care

Medical/Behavioral therapy

Registry

Clinical Study ID

NCT04755413

STUDY00001179

Ages 21-90
All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

Individuals aged 21-90 years with stable CAD.
Patients with any amount of atherosclerosis via coronary angiogram or coronarycomputed tomography angiography (CCTA).
Patients undergoing revascularization therapy or recent acute coronary syndrome (ACS) will be eligible for recruitment and will be recruited at least 4 weeks afteradmission for an ACS or percutaneous intervention and 3 months after coronary bypassgraft surgery.
Patients with CAC levels ≥ 400

Exclusion

Exclusion Criteria:

Planned revascularization,
New York Heart Association class III or IV heart failure symptoms,
LVEF <40%,
eGFR<45,
Pregnancy, congenital heart disease, severe symptomatic valvular heart disease,active malignancy and cardiac transplant.

Study Design

Standard of Care

October 19, 2022

December 31, 2028

Study Description

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.

Connect with a study center

Emory Johns Creek Hospiatl
Atlanta, Georgia 30097
United States
Active - Recruiting
Emory Saint Joseph's Hospital
Atlanta, Georgia 30342
United States
Active - Recruiting
Emory University Hospital
Atlanta, Georgia 30322
United States
Active - Recruiting
Emory University Hospital Midtown
Atlanta, Georgia 30308
United States
Active - Recruiting
The Emory Clinic
Atlanta, Georgia 30324
United States
Active - Recruiting

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