LOUISVILLE, Ky. – UofL Health – Jewish Hospital is advancing cardiovascular prevention with an innovative investigator-initiated trial targeting coronary plaque regression in patients without established coronary artery disease. The Aggressive Risk-Prevention Therapies for Coronary Atherosclerotic Plaque (ARTCAP) study, led by Dinesh Kalra, M.D.,Chief of Cardiology at the University of Louisville School of Medicine, represents a strategic approach to addressing the silent progression of coronary atherosclerosis before clinical events occur.
The trial addresses a fundamental challenge in cardiovascular medicine: the silent nature of coronary atherosclerosis. As coronary plaque typically progresses over 20 or more years without symptoms, most patients remain unaware of their condition until experiencing a heart attack, often the first manifestation of the disease. This clinical reality is particularly relevant given that more than 750,000 Americans suffer heart attacks annually, with cardiovascular disease maintaining its position as the leading cause of death worldwide.
The burden is especially pronounced in Kentucky, which ranks among the bottom five states for heart health, with high prevalence rates of modifiable risk factors including hypertension, smoking, overweight and obesity, poor dietary habits and diabetes.
Study Design and Methodology
ARTCAP employs a comprehensive approach to plaque assessment and intervention. The Institutional Review Board (IRB)-approved trial enrolls asymptomatic patients with identifiable risk factors—including hypertension, diabetes, elevated cholesterol, overweight status or family history of heart disease—who demonstrate coronary plaque presence on cardiac CT imaging.
The study protocol incorporates advanced coronary CT angiography with contrast to provide detailed plaque characterization across all three major coronary arteries. This imaging approach allows for precise assessment of plaque composition, distinguishing between fat-rich and calcified components, which is crucial for treatment stratification.
Participants receive either standard statin therapy alone or a combination regimen incorporating statins with additional cholesterol-lowering medications and anti-inflammatory agents. All medications utilized are FDA-approved and available through standard insurance coverage. The experimental component focuses on the synergistic effects of combination therapy on plaque regression, assessed through repeat CT imaging at 18 months.
The study protocol includes regular clinical assessments with Dr. Kalra’s team at six- to nine-month intervals throughout the 18-month study period. Primary endpoints include quantitative plaque volume changes as measured by serial CT imaging, with investigators targeting 30-50% reduction in plaque burden.
This aggressive target represents a significant advancement beyond previous studies, which have typically demonstrated either slowing of plaque progression or modest reductions of 10-20%. The combination approach targeting multiple pathways involved in plaque development and stability positions this trial to potentially achieve more substantial clinical benefits.
Implications for Cardiovascular Prevention
Dr. Kalra’s approach reflects recent advances in understanding plaque biology and the therapeutic potential of combining cholesterol-lowering and anti-inflammatory strategies. The emphasis on plaque regression rather than mere stabilization represents a paradigm shift in preventive cardiology, potentially offering improved long-term outcomes in terms of reduced myocardial infarction and stroke rates.
The study’s focus on asymptomatic patients with subclinical disease addresses a critical window for intervention, potentially preventing the progression to clinical events that characterize traditional cardiovascular care models.
Study Access and Enrollment
The ARTCAP trial provides participants with comprehensive cardiovascular assessment at no cost, including coronary CT angiography and ongoing clinical monitoring. Eligibility extends to individuals aged 18-80 with cardiovascular risk factors, even in the absence of established coronary artery disease.
Health care providers interested in referring patients or obtaining additional information about the trial can contact the study intake center at 502-852-1845. The study represents an opportunity for patients to access cutting-edge preventive cardiovascular care while contributing to the advancement of coronary plaque regression strategies.
