NCT04755413

The Precision CAD Trial

Use of Biomarker Risk Score to Optimize Therapy in Patients With Coronary Artery Disease: The Precision CAD Trial

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 276 (actual)
• Sponsor: Emory University · Academic / Other
• Sex: All
• Age: 21 Years – 90 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Coronary Artery Disease

Interventions

Type	Name	Description
OTHER	Medical/Behavioral therapy	* Sedentary lifestyle: Advise increasing exercise to at least 30 minutes of moderate-intensity aerobic activity 5 days a week. * Overweight/Obese: Advise calorie reduction, dietician consultation. * Smoking: standard smoking cessation advice and literature and medical therapy as indicated to include Wellbutrin, nicotine patch etc. * High LDL cholesterol: a) Start high dose statin if patient not on high dose statin. b) If on high dose statin, add ezetimibe 10mg daily c) If statin intolerant, start ezetimibe 10mg, colestid or other bile sequestrant combination. d) If still not at goal, start PCSK-9 inhibitor e) LDL cut off of \<55mg/dl in diabetes * Blood Pressure optimization treatment following 2020 International Society of Hypertension Global Hypertension Practice Guidelines. * Diabetes management: HbA1c goal 6.5%
OTHER	Standard of Care	Participants will receive standard of care therapy prescribed by their primary care physician and/or cardiologist.
OTHER	Registry	Participants with BRS of 0 will get measurements of BRS at the time-points specified for the randomized subjects and also for adverse events.

Timeline

• Start date: 2022-10-19
• Primary completion: 2028-12-01
• Completion: 2028-12-01
• First posted: 2021-02-16
• Last updated: 2025-11-21

Locations

5 sites across 1 country: United States