Coronary Computed Tomography Angiography In Rheumatoid Arthritis Study

This prospective, observational study follows individuals with rheumatoid arthritis over time to understand how the disease and its treatment relate to cardiovascular, pulmonary, psychological, and biological outcomes. The study collects standardized clinical data from outpatient rheumatology clinics, complemented by advanced imaging, biological sample collection, and linkage to national health registries.

Study Procedures and Visit Schedule Participants are enrolled during routine or ad-hoc outpatient visits. After informed consent, a baseline evaluation is performed, followed by standardized follow-up visits after approximately 3, 5, and 10 years (± 3-6 months).

At baseline, demographic and lifestyle factors (age, sex, education, smoking, alcohol, physical activity, and family history) are recorded together with anthropometric measures (height, weight, waist circumference) and rheumatoid arthritis characteristics (serologic status, disease duration, erosive disease, and disease activity scores). Concomitant diseases and medications are documented, and vital signs and blood pressure are measured.

Patient-reported outcomes include validated questionnaires on quality of life (Short Form 36, version 1), functional ability (Multidimensional Health Assessment Questionnaire), work productivity (Work Productivity and Activity Impairment - General Health), fatigue and pain visual analogue scales, physical activity (International Physical Activity Questionnaire - Short Form), and shortness of breath (University of California, San Diego Shortness of Breath Questionnaire). Laboratory results, including markers of inflammation and metabolic status, are obtained according to routine standards.

Follow-up visits repeat these assessments to evaluate disease activity, lifestyle changes, and incident comorbidities. Events such as hospitalizations, procedures, and deaths are continuously updated through registry linkage, ensuring complete longitudinal follow-up.

Registry Data Sources All participants are linked to national Danish health and administrative registries to enable comprehensive, long-term follow-up. The study integrates data from the National Patient Registry, the Danish Rheumatology Quality Database, the Civil Registration System, the Danish National Causes of Death Registry, the Western Denmark Heart Registry, the Danish Heart Registry, the Danish Stroke Registry, the Danish National Vascular Registry, the Danish National Database of Reimbursed Prescriptions, the Clinical Laboratory Information System, the Register of Laboratory Results for Research, and the Danish Research Institute for Economic Analysis and Modelling. Linkage across these registries allows continuous capture of clinical events, treatments, and vital status, ensuring complete longitudinal follow-up and verification of outcomes recorded during study visits.

Governance The study is governed by an executive steering committee responsible for overall scientific direction, study design, resource allocation, and regulatory compliance. Supporting boards and advisory groups contribute to patient involvement, methodological quality, and international collaboration. Dedicated centers coordinate site operations, biobanking, cardiac imaging, and data analysis to ensure standardized procedures and data integrity across all participating sites.

All procedures are conducted in accordance with Danish and European data-protection regulations, and data are stored and managed in secure systems compliant with the General Data Protection Regulation.

• Coronary Artery Calcium Score (Agatston score) [Time frame: Baseline]
• The coronary artery plaque surface extent at baseline evaluated for the percent composition of non-calcified-, mixed-, and calcified plaques [Time frame: Baseline]
• Change in Coronary Artery Calcium Score (Agatston units) from baseline to 3 years [Time frame: Baseline and 3 years]
• The quantitative difference in coronary artery plaque surface extent from baseline to 3 years evaluated for the percent composition of non-calcified-, mixed-, and calcified plaques [Time frame: Baseline and 3 year]
• Number of participants with a occurrence of hospitalization for cerebrovascular disease [Time frame: 3, 5 and 10 years]
• Number of participants with a first occurrence of hospitalization for non-fatal myocardial infarction [Time frame: 3, 5 and 10 years]
• Number of participants with a occurrence of hospitalization for non-fatal ischemic stroke [Time frame: 3, 5 and 10 years]
• Number of participants with a occurrence of hospitalization for peripheral vascular disease [Time frame: 3, 5 and 10 years]
• Number of participants with a occurrence of hospitalization for peripheral vascular surgery [Time frame: 3, 5 and 10 years]
• Number of participants with a occurrence of hospitalization for thromboembolic events as defined by deep vein thrombosis and pulmonary embolism [Time frame: 3, 5 and 10 years]
• Number of participants with a first occurrence of hospitalization for PCI [Time frame: 3, 5 and 10 years]
• Number of participants with a first occurrence of hospitalization for CABG [Time frame: 3, 5 and 10 years]