Carotid ultrasound to guide prevention of heart disease in inflammatory rheumatic diseases

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase IV, randomized trial compares a carotid ultrasound-based strategy against standard care for primary prevention of cardiovascular events in adults with inflammatory rheumatic diseases. Participants aged 50 and older with low-to-moderate SCORE2/OP risk are assigned to either the ultrasound-guided approach or ESC 2021-guideline-based management, across multiple centers in Spain. Those in the ultrasound arm are evaluated for carotid plaques to reclassify risk and guide treatment intensity, including high-dose statin therapy if indicated. The study aims to determine whether the ultrasound-driven approach improves cardiovascular outcomes without undue safety concerns. Open-label and multicenter design mirrors real-world practice in rheumatology and cardiology integration.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Patients aged ≥50 years who have provided written informed consent.
2. Fulfillment of classification criteria for at least one of the following inflammatory rheumatic diseases:

   * Rheumatoid arthritis (RA) according to ACR/EULAR 2010 criteria
   * Psoriatic arthritis (PsA) according to CASPAR criteria
   * Axial spondyloarthritis (AxSpA) according to ASAS criteria
   * Systemic lupus erythematosus (SLE) according to ACR/EULAR 2019 criteria
3. Low-to-moderate cardiovascular risk according to SCORE2/OP classification.

Exclusion Criteria:

1. Presence of previous cardiovascular events, type 2 diabetes mellitus, familial hypercholesterolemia, or chronic kidney disease resulting in classification as high or very high cardiovascular risk.
2. Prior carotid ultrasound examination with subsequent therapeutic intervention derived from its results, either in the context of a research study or routine clinical practice.
3. Contraindications to lipid-lowering therapy, including recent history of alcoholism, active liver disease, or unexplained and persistent elevation of serum transaminases exceeding three times the upper limit of normal (applicable to statins and ezetimibe).

Where it's running

• Hospital General Universitario de Alicante
  Alicante, Alicante, Spain Recruiting
• Hospital Vega Baja de Orihuela
  Orihuela, Alicante, Spain Recruiting
• Hospital Universitario Vall d'Hebrón
  Barcelona, Barcelona, Spain Recruiting
• Hospital de Laredo
  Laredo, Cantabria, Spain Recruiting
• Hospital Sierrallana
  Torrelavega, Cantabria, Spain Recruiting
• Hospital Universitario de Basurto
  Bilbao, Vizcaya, Spain Recruiting

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.