By InvitationNot Applicable

Coronary Computed Tomography Angiography In Rheumatoid Arthritis Study

Denmark4,000 participantsStarted 2024-02-21

Plain-language 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.

Who can participate

Age range

50 Years – 75 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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 Exclusion Criteria: * 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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Number of participants with a first occurrence of Major Adverse Cardiovascular Events (MACE)

Timeframe: 3, 5 and 10 years

Number of participants with a first occurrence of any ischemic cardiovascular events, including MACE

Timeframe: 3, 5 and 10 years

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

Timeframe: 3, 5 and 10 years

Trial details

NCT IDNCT07363980

SponsorEllen Margrethe Hauge

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2038-12-31

View on ClinicalTrials.gov More Rheumatoid Arthritis trials

Plain-language summary

Who can participate

Age range

50 Years – 75 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Number of participants with a first occurrence of Major Adverse Cardiovascular Events (MACE)

Timeframe: 3, 5 and 10 years

Number of participants with a first occurrence of any ischemic cardiovascular events, including MACE

Timeframe: 3, 5 and 10 years

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

Timeframe: 3, 5 and 10 years