Coronary Computed Tomography Angiography In Rheumatoid Arthritis Study

NCT07363980 | Enrolling By Invitation

• 1 other identifier: 1-10-72-85-23
• Study Type: observational
• Target: 4,000
• Locations: 1 country
• Sites: 4

Brief 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. 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.

Conditions

Atherosclerotic Ischemic Disease; Pulmonary Disease; Depressive Disorder; Anxiety Disorders; Cardiovascular Biomarkers; Cardiovascular (CV) Risk; Cardiovascular Disease; Cardiovascular Disease (CKD); Cardiovascular Disease (CVD) Risk Factors; COPD (Chronic Obstructive Pulmonary Disease); Pulmonary Diseases or Conditions; Pulmonary Disease, Chronic Obstructive; Depressive and Anxiety Disorders; Lung Cancer (Diagnosis); Cardiovascular and Respiratory Disease; Rheumatoid Arthritis; Interstitial Lung Disease in Patients With Rheumatoid Arthritis

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

Outcome Measures

Primary Outcomes (3)

• 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

  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

  3, 5 and 10 years

• Number of participants with all-cause death (all-cause mortality)

  Death from any cause

  3, 5 and 10 years

Secondary Outcomes (34)

• Coronary Artery Calcium Score (Agatston score)

  Baseline

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

  Baseline

• Change in Coronary Artery Calcium Score (Agatston units) from baseline to 3 years

  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

  Baseline and 3 year

• Number of participants with a occurrence of hospitalization for cerebrovascular disease

  3, 5 and 10 years

Eligibility Criteria

• Age: 50 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with rheumatoid arthritis from rheumatology outpatient clinics across Denmark.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ellen Margrethe Hauge: lead
• University of Aarhus: collaborator
• Aarhus University Hospital: collaborator
• Independent Research Fund Denmark: collaborator
• Alfasigma S.p.A.: collaborator
• ATACC-RD consortium: collaborator
• The Danish Rheumatism Association: collaborator

Study Sites (4)

Aarhus University Hospital

Aarhus, Denmark

Location

Esbjerg Hospital

Esbjerg, Denmark

Location

Regional Hospital Gødstrup

Herning, Denmark

Location

Silkeborg Regional Hospital

Herning, Denmark

Location

Biospecimen

Retention: SAMPLES WITH DNA

1. Blood biobank 2. Faeces microbiome biobank

MeSH Terms

Conditions

Arthritis, Rheumatoid; Lung Diseases; Depressive Disorder; Anxiety Disorders; Respiration Disorders; Cardiovascular Diseases; Pulmonary Disease, Chronic Obstructive; Lung Neoplasms; Disease

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Respiratory Tract Diseases; Mood Disorders; Mental Disorders; Lung Diseases, Obstructive; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms

Study Officials

• Ellen-Margrethe Hauge, MD, PhD

  Aarhus University Hospital and Aarhus University

  STUDY CHAIR

• Dzenan Masic, MD, PhD

  Aarhus University Hospital and Aarhus University

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Chair professor

Study Record Dates

• First Submitted: January 15, 2026
• First Posted: January 23, 2026
• Study Start: February 21, 2024
• Primary Completion (Estimated): December 31, 2038
• Study Completion (Estimated): December 31, 2040
• Last Updated: February 3, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, ANALYTIC CODE
• Time Frame: After completion of the study.
• Access Criteria: Individuals who obtain approval from the Danish Ethical Review Authority, the authority responsible for personal data, and the COTIRA Steering Committee will be able to access all PIDs as described above.

Locations

DK (4)