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

Status: Recruiting
Location: See all (5) locations...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 21
Maximum Age: 90
Healthy Volunteers: f
View:

• 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

Locations
United States
Georgia
Emory Johns Creek Hospiatl
RECRUITING
Atlanta
Emory Saint Joseph's Hospital
RECRUITING
Atlanta
Emory University Hospital
RECRUITING
Atlanta
Emory University Hospital Midtown
RECRUITING
Atlanta
The Emory Clinic
RECRUITING
Atlanta
Contact Information
Primary
Joey Freshwater
joey.freshwater@emory.edu
404-712-6635
Time Frame
Start Date: 2022-10-19
Estimated Completion Date: 2028-12
Participants
Target number of participants: 450
Treatments
Experimental: 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.
Active_comparator: 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.
Other: 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.
Sponsors
Leads: Emory University

This content was sourced from clinicaltrials.gov