The Precision CAD Trial

NCT ID: NCT04755413

Last Updated: 2025-11-21

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 276 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-10-19
• Study Completion Date: 2028-12-31

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.

Conditions

Coronary Artery Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Optimization Group

Participants with CAD and a BRS greater than 0 who are randomized to the Optimization Group have treatment goals that include achieving LDL-C\<70 mg/dL, hemoglobin A1c \<7%, blood pressure \<130/80 mmHg, smoking cessation, at least 30 minutes of moderate-intensity aerobic activity 5 days a week and weight loss to body mass index \<30 kg/m2. To achieve these goals, both pharmacological and lifestyle interventions will be considered and individualized for each patient.

Group Type: EXPERIMENTAL

Medical/Behavioral therapy

Intervention Type: OTHER

• 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%

Usual Care Group

Participants with CAD and a BRS greater than 0 who are randomized to the usual care group will receive standard of care therapy prescribed by their primary care physician and/or cardiologist. Patients and their physicians will be informed that their BRS is ≥1 and they have been randomized to the usual care group.

Group Type: ACTIVE_COMPARATOR

Standard of Care

Intervention Type: OTHER

Participants will receive standard of care therapy prescribed by their primary care physician and/or cardiologist.

Registry Group

Participants with BRS of 0 at baseline and after 3 months will undergo follow-up including measurements of BRS at the time-points specified for the randomized subjects and also for adverse events. Laboratory results and questionnaire data will be obtained on the phone.

Group Type: OTHER

Registry

Intervention Type: OTHER

Participants with BRS of 0 will get measurements of BRS at the time-points specified for the randomized subjects and also for adverse events.

Interventions

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%

Intervention Type: OTHER

Standard of Care

Participants will receive standard of care therapy prescribed by their primary care physician and/or cardiologist.

Intervention Type: 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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Individuals aged 21-90 years with stable CAD.
• Patients with any amount of atherosclerosis via coronary angiogram or coronary computed 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 after admission for an ACS or percutaneous intervention and 3 months after coronary bypass graft surgery.
• Patients with CAC levels ≥ 400

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.

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Emory University

OTHER

Sponsor Role: lead

Responsible Party

Arshed A. Quyyumi

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Arshed Quyyumi, MD

Role: PRINCIPAL_INVESTIGATOR

Emory University

Locations

Emory Johns Creek Hospiatl

Atlanta, Georgia, United States

Emory University Hospital Midtown

Atlanta, Georgia, United States

Emory University Hospital

Atlanta, Georgia, United States

The Emory Clinic

Atlanta, Georgia, United States

Emory Saint Joseph's Hospital

Atlanta, Georgia, United States

Countries

United States

Other Identifiers

STUDY00001179

Identifier Type: -

Identifier Source: org_study_id