An observational study in Rheumatoid Arthritis, Atherosclerotic Ischemic Disease and Pulmonary Disease, sponsored by Ellen Margrethe Hauge. Enrolling by invitation at 4 sites in Denmark. Open to participants aged 50 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-02-03.
Sponsored by Ellen Margrethe Hauge · Observational
The Coronary Computed Tomography Angiography in Rheumatoid Arthritis study is part of the multinational, prospective, observational Autoimmunity and Atherosclerosis in Rheumatic Diseases cohort (https://atacc-rd.com) that includes comprehensive baseline and follow-up assessments at 3, 5, and 10 years. It comprises a main protocol and several optional modules, including a Cardiac Imaging Module, Biobanking Module, Pulmonary Module, and Anxiety and Depression Module.
The study aims to advance understanding of cardiopulmonary and psychological comorbidities in rheumatoid arthritis, to improve early identification and management, and to enhance insights into underlying disease mechanisms-ultimately refining risk stratification and targeted prevention strategies.
The study includes 4,000 patients with rheumatoid arthritis enrolled through the Cardiac Imaging Module in the main protocol. Participants undergo coronary computed tomography angiography, pulmonary function testing, physical examination, questionnaires, and biobanking, supplemented by genetic, proteomic, metabolomic, and microbiome profiling.
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.
2,888 studies on the registry are indexed under Arthritis, Rheumatoid; 390 are open to participants now.
This study's planned enrollment of 4,000 is above the median of 176 across 824 observational studies indexed under Arthritis, Rheumatoid.
Browse Arthritis, Rheumatoid studies →This is the only study on the registry with Ellen Margrethe Hauge as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Patients with rheumatoid arthritis from rheumatology outpatient clinics across Denmark.
Exclusion Criteria:
Number of participants with a first occurrence of Major Adverse Cardiovascular Events (MACE)
1. Cardiovascular death as defined by death from any of the following causes: Ischemic heart disease; Sudden cardiac death; Ventricular tachycardia; Other cardiac arrhythmias; Heart failure; Fatal ischemic stroke; Sudden undefined death; Unwitnessed or unknown cause of death 2. Hospitalization for non-fatal myocardial infarction, including hospitalization for PCI and CABG 3. Hospitalization for non-fatal ischemic stroke
Time frame: 3, 5 and 10 years
Number of participants with a first occurrence of any ischemic cardiovascular events, including MACE
Hospitalization for cerebrovascular disease (transient ischemic attack). Hospitalization for peripheral vascular disease. Hospitalization for peripheral vascular surgery. Cardiovascular death as defined by death from any of the following causes: Ischemic heart disease; Sudden cardiac death; Ventricular tachycardia; Other cardiac arrhythmias; Heart failure; Fatal ischemic stroke; Sudden undefined death; Unwitnessed or unknown cause of death. Hospitalization for non-fatal myocardial infarction, including hospitalization for PCI and CABG. Hospitalization for non-fatal ischemic stroke
Time frame: 3, 5 and 10 years
Number of participants with all-cause death (all-cause mortality)
Death from any cause
Time frame: 3, 5 and 10 years
Coronary Artery Calcium Score (Agatston score)
Coronary Artery Calcium Score (CACS), Agatston units. Minimum: 0. Maximum: No upper limit. Higher score indicates worse outcome (more coronary artery calcification).
Time frame: Baseline
The coronary artery plaque surface extent at baseline evaluated for the percent composition of non-calcified-, mixed-, and calcified plaques
Quantitative plaque measurement
Time frame: Baseline
Change in Coronary Artery Calcium Score (Agatston units) from baseline to 3 years
Coronary Artery Calcium Score (Agatston score), Agatston units. Change (Δ) in Coronary Artery Calcium Score (CACS) calculated as 3-year CACS minus baseline CACS. Minimum: No lower limit (negative). Maximum: No upper limit (positive). A positive change indicates increasing calcification (worse); a negative change indicates decreasing calcification (better).
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
Quantitative plaque measurement
Time frame: Baseline and 3 year
Number of participants with a occurrence of hospitalization for cerebrovascular disease
Source of data: patient, record, registry
Time frame: 3, 5 and 10 years
Number of participants with a first occurrence of hospitalization for non-fatal myocardial infarction
Source of data: patient, record, registry
Time frame: 3, 5 and 10 years
Number of participants with a occurrence of hospitalization for non-fatal ischemic stroke
Source of data: patient, record, registry
Time frame: 3, 5 and 10 years
Number of participants with a occurrence of hospitalization for peripheral vascular disease
Source of data: patient, record, registry
Time frame: 3, 5 and 10 years
Number of participants with a occurrence of hospitalization for peripheral vascular surgery
Source of data: patient, record, registry
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
Source of data: patient, record, registry
Time frame: 3, 5 and 10 years
Number of participants with a first occurrence of hospitalization for PCI
Source of data: patient, record, registry
Time frame: 3, 5 and 10 years
Number of participants with a first occurrence of hospitalization for CABG
Source of data: patient, record, registry
Time frame: 3, 5 and 10 years
Number of participants with a first occurrence of treatment for stable angina pectoris
Source of data: patient, record, registry
Time frame: 3, 5 and 10 years
Number of participants with a occurrence of treatment for atrial fibrillation and flutter
Source of data: patient, record, registry
Time frame: 3, 5 and 10 years
Number of participants with sudden death
Source of data: record and registry
Time frame: 3, 5 and 10 years
Number of participants with cardiovascular death
Source of data: record and registry
Time frame: 3, 5 and 10 years
Number of participants with a occurrence of treatment for essential hypertension with/without complications
Source of data: patient, record, registry
Time frame: 3, 5 and 10 years
Number of participants with a occurrence of treatment for disorders of lipoprotein metabolism and other lipidemias
Source of data: patient, record, registry
Time frame: 3, 5 and 10 years
Number of participants with a occurrence of treatment for diabetes mellitus
Source of data: patient, record, registry
Time frame: 3, 5 and 10 years
Number of participants with a occurrence of hospitalization for respiratory disease
Source of data: patient, record, registry
Time frame: 3, 5 and 10 years
Number of participants with a occurrence of hospitalization or specialist-initiated treatment for interstitial pulmonary diseases
Source of data: patient, record, registry
Time frame: 3, 5 and 10 years
Number of participants with a occurrence of hospitalization or specialist-initiated treatment for chronic lower respiratory diseases
Source of data: patient, record, registry
Time frame: 3, 5 and 10 years
Number of participants with a occurrence of hospitalization or specialist-initiated treatment for anxiety disorders, including generalized anxiety disorder
Source of data: patient, record, registry
Time frame: 3, 5 and 10 years
Number of participants with a occurrence of hospitalization or specialist-initiated treatment for a depressive episode or recurrent major depressive disorder
Source of data: patient, record, registry
Time frame: 3, 5 and 10 years
Number of participants with a occurrence of general practitioner-initiated treatment for anxiety disorders
Source of data: patient, record, registry
Time frame: 3, 5 and 10 years
Number of participants with a occurrence of general practitioner-initiated treatment for depression
Source of data: patient, record, registry
Time frame: 3, 5 and 10 years
Number of participants with a occurrence of referral to a psychologist or psychiatrist
Source of data: patient, record, registry
Time frame: 3, 5 and 10 years
Number of participants with a occurrence of infection with Mycobacterium tuberculosis
Source of data: patient, record, registry
Time frame: 3, 5 and 10 years
Number of participants with a occurrence of opportunistic infections
Source of data: patient, record, registry
Time frame: 3, 5 and 10 years
Number of participants with a occurrence of hospitalization for infections (suspected/confirmed)
Source of data: patient, record, registry
Time frame: 3, 5 and 10 years
Proteomics concentrations
Blood sample
Time frame: Baseline, 3, 5 and 10 years
Metabolomics concentration
Blood and stool sample
Time frame: Baseline, 3, 5 and 10 years
Microbiome profile of stool
Stool sample
Time frame: Baseline, 3, 5 and 10 years
Genome-, epigenom-, and RNA sequencing
Blood sample
Time frame: Baseline, 3, 5 and 10 years
Plan to share: Yes — All IPD collected throughout the study.
Supporting information: Study protocol, Icf, Analytic code
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