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Rheumatoid ArthritisCOTIRANCT07363980

Coronary Computed Tomography Angiography In Rheumatoid Arthritis Study

An observational study of Rheumatoid Arthritis and Atherosclerotic Ischemic Disease, run by Ellen Margrethe Hauge at 4 sites in Denmark.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record

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Trial summary

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. Read more about this study

Who is it for?
Ages 50 to 75 years
How many people
4,000 participants
Where
4 sitesDenmark
Study dates
21 Feb 2024to 31 Dec 2040
Phase
Observational

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients with rheumatoid arthritis from rheumatology outpatient clinics across Denmark.

Who may be able to join

  • Fulfill the ACR/EULAR-2010 criteria for rheumatoid arthritis
  • Attending or has attended at least one visit during the last two years in rheumatology outpatient clinic for diagnostic or monitoring purposes related to rheumatoid arthritis
  • Age 50-75 years

Who cannot join

  • Diagnosed with overlapping systemic autoimmune diseases other than secondary Sjogren's syndrome
  • Active cancer
  • Prior coronary atherosclerotic symptoms as defined by myocardial infraction, percutaneous coronary intervention, or coronary artery bypass grafting
  • Allergy to radiocontrast agents
  • Estimated glomerular filtration rate (eGFR) < 30 mL/min
  • BMI > 35 kg/m2
  • Persistent atrial fibrillation

Trial locations and contacts

4 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Denmark4 sites

  • Aarhus University Hospital

    Aarhus

  • Esbjerg Hospital

    Esbjerg

  • Regional Hospital Gødstrup

    Herning

  • Silkeborg Regional Hospital

    Herning

Other trials in Denmark

About this study

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.

Read the detailed description

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.

Keywords
Coronary Computed Tomography Angiography, Pulmonary function tests, Biobank, Faecal microbiome, Patient reported outcomes, Genome sequencing, RNA sequencing, Epigenom sequencing, Coronary Artery Calcium Score, Proteomics, Metabolomics, Lipidomics, Multi-omics, Patient-reported outcomes, Disease Activity Score-28 for Rheumatoid Arthritis, Deep phenotyping, Coronary plaque analysis
Medical subject headings
Arthritis, Rheumatoid, Lung Diseases, Depressive Disorder, Anxiety Disorders, Respiration Disorders, Cardiovascular Diseases, Pulmonary Disease, Chronic Obstructive, Lung Neoplasms

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: 3, 5 and 10 years

  2. 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

    Measured: 3, 5 and 10 years

  3. Number of participants with all-cause death (all-cause mortality)

    Death from any cause

    Measured: 3, 5 and 10 years

Secondary outcomes (34)

  1. 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).

    Measured: Baseline

  2. The coronary artery plaque surface extent at baseline evaluated for the percent composition of non-calcified-, mixed-, and calcified plaques

    Quantitative plaque measurement

    Measured: Baseline

  3. 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).

    Measured: Baseline and 3 years

  4. 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

    Measured: Baseline and 3 year

  5. Number of participants with a occurrence of hospitalization for cerebrovascular disease

    Source of data: patient, record, registry

    Measured: 3, 5 and 10 years

  6. Number of participants with a first occurrence of hospitalization for non-fatal myocardial infarction

    Source of data: patient, record, registry

    Measured: 3, 5 and 10 years

  7. Number of participants with a occurrence of hospitalization for non-fatal ischemic stroke

    Source of data: patient, record, registry

    Measured: 3, 5 and 10 years

  8. Number of participants with a occurrence of hospitalization for peripheral vascular disease

    Source of data: patient, record, registry

    Measured: 3, 5 and 10 years

  9. Number of participants with a occurrence of hospitalization for peripheral vascular surgery

    Source of data: patient, record, registry

    Measured: 3, 5 and 10 years

  10. 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

    Measured: 3, 5 and 10 years

  11. Number of participants with a first occurrence of hospitalization for PCI

    Source of data: patient, record, registry

    Measured: 3, 5 and 10 years

  12. Number of participants with a first occurrence of hospitalization for CABG

    Source of data: patient, record, registry

    Measured: 3, 5 and 10 years

  13. Number of participants with a first occurrence of treatment for stable angina pectoris

    Source of data: patient, record, registry

    Measured: 3, 5 and 10 years

  14. Number of participants with a occurrence of treatment for atrial fibrillation and flutter

    Source of data: patient, record, registry

    Measured: 3, 5 and 10 years

  15. Number of participants with sudden death

    Source of data: record and registry

    Measured: 3, 5 and 10 years

  16. Number of participants with cardiovascular death

    Source of data: record and registry

    Measured: 3, 5 and 10 years

  17. Number of participants with a occurrence of treatment for essential hypertension with/without complications

    Source of data: patient, record, registry

    Measured: 3, 5 and 10 years

  18. Number of participants with a occurrence of treatment for disorders of lipoprotein metabolism and other lipidemias

    Source of data: patient, record, registry

    Measured: 3, 5 and 10 years

  19. Number of participants with a occurrence of treatment for diabetes mellitus

    Source of data: patient, record, registry

    Measured: 3, 5 and 10 years

  20. Number of participants with a occurrence of hospitalization for respiratory disease

    Source of data: patient, record, registry

    Measured: 3, 5 and 10 years

  21. Number of participants with a occurrence of hospitalization or specialist-initiated treatment for interstitial pulmonary diseases

    Source of data: patient, record, registry

    Measured: 3, 5 and 10 years

  22. Number of participants with a occurrence of hospitalization or specialist-initiated treatment for chronic lower respiratory diseases

    Source of data: patient, record, registry

    Measured: 3, 5 and 10 years

  23. 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

    Measured: 3, 5 and 10 years

  24. 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

    Measured: 3, 5 and 10 years

  25. Number of participants with a occurrence of general practitioner-initiated treatment for anxiety disorders

    Source of data: patient, record, registry

    Measured: 3, 5 and 10 years

  26. Number of participants with a occurrence of general practitioner-initiated treatment for depression

    Source of data: patient, record, registry

    Measured: 3, 5 and 10 years

  27. Number of participants with a occurrence of referral to a psychologist or psychiatrist

    Source of data: patient, record, registry

    Measured: 3, 5 and 10 years

  28. Number of participants with a occurrence of infection with Mycobacterium tuberculosis

    Source of data: patient, record, registry

    Measured: 3, 5 and 10 years

  29. Number of participants with a occurrence of opportunistic infections

    Source of data: patient, record, registry

    Measured: 3, 5 and 10 years

  30. Number of participants with a occurrence of hospitalization for infections (suspected/confirmed)

    Source of data: patient, record, registry

    Measured: 3, 5 and 10 years

  31. Proteomics concentrations

    Blood sample

    Measured: Baseline, 3, 5 and 10 years

  32. Metabolomics concentration

    Blood and stool sample

    Measured: Baseline, 3, 5 and 10 years

  33. Microbiome profile of stool

    Stool sample

    Measured: Baseline, 3, 5 and 10 years

  34. Genome-, epigenom-, and RNA sequencing

    Blood sample

    Measured: Baseline, 3, 5 and 10 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Jan 2026
  2. Study start21 Feb 2024
  3. Primary completion31 Dec 2038 (estimated)
  4. Study completion31 Dec 2040 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
4,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07363980
Sponsor's protocol ID
1-10-72-85-23
Acronym
COTIRA
Status last verified
Jan 2026
First submitted
15 Jan 2026
Last updated
3 Feb 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: All IPD collected throughout the study.

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