The Precision CAD Trial
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
🗓️ Study Start (Actual) 19 October 2022
🗓️ Primary Completion (Estimated) December 2028
✅ Study Completion (Estimated) December 2028
👥 Enrollment (Estimated) 450
🔬 Study Type INTERVENTIONAL
📊 Phase NA
Locations:
📍 Atlanta, Georgia, United States
📍 Atlanta, Georgia, United States
📍 Atlanta, Georgia, United States
📍 Atlanta, Georgia, United States
📍 Atlanta, Georgia, United States

📋 Eligibility Criteria

Description

    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.
Ages Eligible for Study: 21 Years to 90 Years (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 11 February 2021
  • First Submitted that Met QC Criteria 11 February 2021
  • First Posted 16 February 2021

Study Record Updates

  • Last Update Submitted that Met QC Criteria 25 October 2023
  • Last Update Posted 26 October 2023
  • Last Verified October 2023