Randomized Clinical Trial to Evaluate Carotid Ultrasound Strategy for Preventing Cardiovascular Events in Patients With Inflammatory Rheumatic Diseases

What this Trial Is About

Researchers are evaluating a new approach to prevent heart and blood vessel problems in patients with inflammatory rheumatic diseases (such as rheumatoid arthritis, psoriatic arthritis, axial spondyloarthritis, and systemic lupus erythematosus). These patients have a 50% higher chance of cardiovascular events compared to the general population, and current risk scores often underestimate their true risk. This phase IV clinical trial aims to test if using carotid ultrasound to detect early artery disease can better identify patients at high risk and improve prevention. Participants aged 50 years and older with inflammatory rheumatic diseases and low-to-moderate cardiovascular risk will be randomly assigned to either receive a carotid ultrasound or follow standard care based on current guidelines. Those in the ultrasound group found to have carotid plaques will be classified as very high risk and started on high-intensity statin therapy to lower LDL cholesterol below 55 mg/dL. Patients without plaques and those in the control group will receive care according to the European Society of Cardiology 2021 recommendations. The study will last 48 months with ongoing monitoring. Throughout the study, patients will have regular visits to track their health and treatment effects. Those needing lipid-lowering therapy will have monthly visits during treatment adjustment, then every six months until the study ends. All patients will be monitored for major cardiovascular events such as heart attacks, strokes, and hospitalizations over four years. Safety and side effects will also be evaluated, aiming to see if the ultrasound-based strategy better prevents heart problems compared to standard care.

Carotid Ultrasound-Based Strategy for Primary Prevention of Cardiovascular Events in Inflammatory Rheumatic Disease (PREVENER)