The Precision CAD Trial

NCT04755413 | Active Not Recruiting DMC

• 1 other identifier: STUDY00001179
• Study Type: interventional
• Target: 276
• Locations: 1 country
• Sites: 5

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.

Conditions

Coronary Artery Disease

Keywords

Coronary Artery Disease; Biomarkers

Outcome Measures

Primary Outcomes (6)

• Change in plasma levels of hsCRP

  Blood will be drawn for measurement of plasma levels of hsCRP to compare the optimization group and the usual care group.

  Baseline, 1 year post intervention

• Change in plasma levels of hs-cTnI

  Blood will be drawn for measurement of plasma levels of hs-cTnI to compare the optimization group and the usual care group.

  Baseline, 1 year post intervention

• Change in plasma levels of BNP

  Blood will be drawn for measurement of plasma levels of BNP to compare the optimization group and the usual care group.

  Baseline, 1 year post intervention

• Change in plasma levels of suPAR

  Blood will be drawn for measurement of plasma levels of suPAR to compare the optimization group and the usual care group.

  Baseline, 1 year post intervention

• Change in Biomarker Risk Score (BRS)

  The BRS score is a simple and manual observation of 4 biomarker results above a predetermined cutpoint that are run on FDA cleared and or CE marked platforms. The BRS is calculated using levels of the 4 biomarkers. Biomarker levels will be considered abnormal if hsCRP is \>3 mg/L, suPAR (pg/mL) \>2863 (males) and \>4063 (women), hs-TnI (pg/mL)\> 6.3 (men), \>5.5 (women), and BNP (pg/mL) \>122 (men), \>184.1 (women). The BRS ranges from 0 to 4 based on the number of biomarkers that are elevated above these cut off values. Higher score correlates with worse outcome.

  Baseline, 1 year post intervention

• Change in composite complications

  Difference in rates of composite of CV death/MI/ heart failure hospitalizations, stroke/ revascularization between optimization group, usual care group and registry group.

  Baseline, 1,3,6,9 months post intervention and 1,2,3,5 years post intervention

Secondary Outcomes (5)

• Change in plasma levels of hsCRP

  Baseline, 1, 3, 6, 9 months post intervention and 2, 3, 5 years post intervention

• Change in plasma levels of hs-cTnI

  Baseline, 1, 3, 6, 9 months post intervention and 2, 3, 5 years post intervention

• Change in plasma levels of BNP

  Baseline, 1, 3, 6, 9 months post intervention and 2, 3, 5 years post intervention

• Change in plasma levels of suPAR

  Baseline, 1, 3, 6, 9 months post intervention and 2, 3, 5 years post intervention

• All cause death

  5 years post intervention

Study Arms (3)

Optimization Group

EXPERIMENTAL

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.

Other: Medical/Behavioral therapy

Usual Care Group

ACTIVE COMPARATOR

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.

Other: Standard of Care

Registry Group

OTHER

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.

Other: Registry

Interventions

Medical/Behavioral therapy 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%

Optimization Group

Standard of Care OTHER

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

Usual Care Group

Registry 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.

Registry Group

Eligibility Criteria

• Age: 21 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Emory University: lead

Study Sites (5)

Emory Johns Creek Hospiatl

Atlanta, Georgia, 30097, United States

Location

Emory University Hospital Midtown

Atlanta, Georgia, 30308, United States

Location

Emory University Hospital

Atlanta, Georgia, 30322, United States

Location

The Emory Clinic

Atlanta, Georgia, 30324, United States

Location

Emory Saint Joseph's Hospital

Atlanta, Georgia, 30342, United States

Location

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

Behavior Therapy; Standard of Care; Registries

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Psychotherapy; Behavioral Disciplines and Activities; Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation; Data Collection; Epidemiologic Methods; Investigative Techniques; Records; Organization and Administration; Health Care Evaluation Mechanisms; Public Health; Environment and Public Health

Study Officials

• Arshed Quyyumi, MD

  Emory University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 11, 2021
• First Posted: February 16, 2021
• Study Start: October 19, 2022
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: November 21, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (5)