Aggressive Risk-Prevention Therapies for Coronary Atherosclerotic Plaque (ART-CAP)
The purpose of this study is to evaluate the role of coronary CT angiogram (CCTA) as a superior guide for the assessment of coronary artery plaque and guiding treatment decisions. The investigators also assess the impact of preventive cardiovascular drugs on the plaque to improve patient outcomes. Participants aged 18-80 years, at intermediate or high-risk for coronary artery disease, with non-obstructive plaque on initial CCTA, will be enrolled in this study. They will be randomized into Standard of Care (SOC) vs. Aggressive Therapy (AT) groups. Both groups will undergo dietary and lifestyle interventions. Follow-up will consist of blood tests and clinic visits at baseline, 9 months, and 18 months. The second CCTA will be performed at 18 months to assess the change in plaque burden, characteristics, ischemia and pericoronary/epicardial fat.
Conditions:
🦠 Coronary Artery Disease 🦠 Atherosclerosis 🦠 Heart Attack
🗓️ Study Start (Actual) 1 March 2024
🗓️ Primary Completion (Estimated) 31 January 2029
✅ Study Completion (Estimated) 31 January 2029
👥 Enrollment (Estimated) 200
🔬 Study Type INTERVENTIONAL
📊 Phase PHASE4
Locations:
📍 Louisville, Kentucky, United States

📋 Eligibility Criteria

Description

    Inclusion Criteria:

    • Non-obstructive atherosclerotic coronary artery plaque (stenosis of 0-39% or stenosis of 40-69% with FFR-CT \>0.8) in a major epicardial vessel \> 2 mm in diameter.

    Exclusion Criteria:

    • 1. coronary/PAD/carotid revascularization or ischemic stroke or TIA within 6 months prior to enrollment
    • 2. Valvular heart disease of moderate or worse severity or requiring interventional procedures or surgery
    • 3. LVEF \<35% in the past 12 months
    • 4. Pulmonary hypertension with PASP\>50 mm Hg in the past 12 months
    • 5. Myocarditis or pericarditis in the past 12 months
    • 6. Known Cardiomyopathy (hypertrophic, infiltrative, restrictive, dilated, etc.)
    • 7. Heart failure NYHA class 3 or 4
    • 8. Hospitalization for heart failure in the preceding 6 months
    • 9. Life expectancy of \<1 year
    • 10. An organ-transplant recipient or if felt to require listing for solid organ transplantation during study status
    • 11. Inability to give informed consent
    • 12. Active malignancy (except basal cell skin cancer)
    • 13. Cirrhosis
    • 14. ESRD
    • 15. Pregnancy or planning to conceive during the study period
    • 16. Known intolerance or perceived contraindication to any of the study drugs during the study period including statins or aspirin if indicated
    • 17. eGFR\<30 ml/min/m2
    • 18. Inability to receive iodinated contrast for CCTA
    • 19. Chronic immunosuppression therapy
    • 20. Uncontrolled psychiatric illness
Ages Eligible for Study: 18 Years to 80 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 5 February 2024
  • First Submitted that Met QC Criteria 19 February 2024
  • First Posted 28 February 2024

Study Record Updates

  • Last Update Submitted that Met QC Criteria 23 April 2024
  • Last Update Posted 25 April 2024
  • Last Verified April 2024