Clinical trial NCT04755413: The Precision CAD Trial
Official title: Use of Biomarker Risk Score to Optimize Therapy in Patients With Coronary Artery Disease: The Precision CAD Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Coronary Artery Disease
Keywords: Coronary Artery Disease
Biomarkers
Lead sponsor: Emory University
Sponsor class: OTHER
First posted: 2021-02-16
Enrollment: 450
Sex: ALL
Minimum age (years): 21
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: Change in plasma levels of hsCRP
timeFrame: Baseline, 1 year post intervention
measure: Change in plasma levels of hs-cTnI
timeFrame: Baseline, 1 year post intervention
measure: Change in plasma levels of BNP
timeFrame: Baseline, 1 year post intervention
measure: Change in plasma levels of suPAR
timeFrame: Baseline, 1 year post intervention
measure: Change in Biomarker Risk Score (BRS)
timeFrame: Baseline, 1 year post intervention
measure: Change in composite complications
timeFrame: Baseline, 1,3,6,9 months post intervention and 1,2,3,5 years post intervention
Secondary outcomes:
measure: Change in plasma levels of hsCRP
timeFrame: Baseline, 1, 3, 6, 9 months post intervention and 2, 3, 5 years post intervention
measure: Change in plasma levels of hs-cTnI
timeFrame: Baseline, 1, 3, 6, 9 months post intervention and 2, 3, 5 years post intervention
measure: Change in plasma levels of BNP
timeFrame: Baseline, 1, 3, 6, 9 months post intervention and 2, 3, 5 years post intervention
measure: Change in plasma levels of suPAR
timeFrame: Baseline, 1, 3, 6, 9 months post intervention and 2, 3, 5 years post intervention
measure: All cause death
timeFrame: 5 years post intervention
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Emory Johns Creek Hospiatl
state: Georgia
city: Atlanta
country: United States
facility: Emory University Hospital Midtown
state: Georgia
city: Atlanta
country: United States
facility: Emory University Hospital
state: Georgia
city: Atlanta
country: United States
facility: The Emory Clinic
state: Georgia
city: Atlanta
country: United States
facility: Emory Saint Joseph's Hospital
state: Georgia
Study officials:
affiliation: Emory University
name: Arshed Quyyumi, MD
role: PRINCIPAL_INVESTIGATOR
References: