The Precision CAD Trial

Coronary Artery Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04755413
• Other study ID #: STUDY00001179
• Status: Recruiting
• Phase: N/A
• Start date: October 19, 2022
• Est. completion date: December 2028

Study information

• Verified date: October 2023
• Source: Emory University
• Contact: Joey Freshwater
• Phone: 404-712-6635
• Email: joey.freshwater[@]emory.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 450
• Est. completion date: December 2028
• Est. primary completion date: December 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

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

Locations

Country	Name	City	State
United States	Emory Johns Creek Hospiatl	Atlanta	Georgia
United States	Emory Saint Joseph's Hospital	Atlanta	Georgia
United States	Emory University Hospital	Atlanta	Georgia
United States	Emory University Hospital Midtown	Atlanta	Georgia
United States	The Emory Clinic	Atlanta	Georgia

Sponsors (1)

Lead Sponsor	Collaborator
Emory University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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, 3, 6, 9 months post intervention and 2, 3, 5 years post intervention
Secondary	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, 3, 6, 9 months post intervention and 2, 3, 5 years post intervention
Secondary	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, 3, 6, 9 months post intervention and 2, 3, 5 years post intervention
Secondary	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, 3, 6, 9 months post intervention and 2, 3, 5 years post intervention
Secondary	All cause death	All cause death at 5 years in the optimization group compared to usual care group.	5 years post intervention