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NCT Number: NCT05647577

The Relationship Between Inflammatory ARTritis and CArdiac DIseAse

The goal of this prospective cohort study is to investigate cardiac comorbidity in a random sample of approximately 1200 patients from a population of outpatients with rheumatoid arthritis and axial spondyloarthritis referred to collectively as inflammatory arthritis (IA). The main questions it aims to answer are:

* Using conventional echocardiography, the investigators aim to determine the prevalence of overt and asymptomatic cardiac dysfunction in a large random sample of outpatients with IA. Cardiac dysfunction will be evaluated by echocardiography and cardiac biomarkers (NT-pro-BNP, hs-TNT and hs-CRP). * In patients without known heart disease: Using 2, 5 and 10 year follow-up, the investigators aim to examine if advanced echocardiography can be used to detect early signs of heart disease by investigating the clinical significance of adding deformation measures - alone and in combination with selected biomarkers - to conventional risk factors in the cardiac risk assessment of patients with IA

Participants will undergo an echocardiographic examination in combination with a general health assessment including obtainment of cardiac biomarkers and a electrocardiogram.

Using advanced echocardiography - Tissue Doppler Imaging, 2- dimensional speckle tracking echocardiography, 3D-echocardiography and 3-dimensional speckle tracking echocardiography - the investigators also aim to compare myocardial deformation parameters of patients with IA to a gender and age matched control group without IA from the Copenhagen City Heart Study.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Inflammatory Arthritis Ankylosis Arthritis Arthritis, Rheumatoid Autoimmune Diseases Axial Spondyloarthritis Bone Diseases Brain Diseases Cardiac Disease Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Connective Tissue Diseases Heart Diseases Heart Failure Heart Failure, Diastolic Heart Failure, Systolic Heart Valve Diseases Immune System Diseases Infarction Ischemia Ischemic Heart Disease Joint Diseases Left Ventricular Systolic Dysfunction Musculoskeletal Diseases Myocardial Dysfunction Myocardial Infarction Myocardial Ischemia Necrosis Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Rheumatic Diseases Rheumatoid Arthritis Skin and Connective Tissue Diseases Spinal Diseases Spondylarthritis Spondylarthropathies Spondylitis Spondylitis, Ankylosing Spondyloarthritis Stroke Valvular Heart Disease Vascular Diseases Ventricular Dysfunction Ventricular Dysfunction, Left

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Cardiology | Center for Translational Cardiology and Pragmatic Randomized Trials (CTCPR) Cardiovascular Non-Invasive Imaging Research Laboratory (CIRL)

Hellerup, 2900, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Persons with a diagnosis of with a confirmed diagnosis of rheumatoid Arthritis or axial spondyloarthritis

Exclusion criteria

  • Persons not able to cooperate
  • Persons unable understand and sign "informed consent"

Treatment and study plan

Primary outcomes

  1. Cardiovascular mortality

    Time frame: 2-year follow-up

  2. Cardiovascular mortality

    Time frame: 5-year follow-up

  3. Cardiovascular mortality

    Time frame: 10 year outcome

  4. Admission with congestive heart failure

    Time frame: 2-year follow-up

  5. Admission with congestive heart failure

    Time frame: 5-year follow-up

  6. Admission with congestive heart failure

    Time frame: 10 years

  7. Myocardial infarction

    Time frame: 2-year follow-up

  8. Myocardial infarction

    Time frame: 5-year follow-up

  9. Myocardial infarction

    Time frame: 10 years

  10. Revascularization

    Time frame: 2-year follow-up

    Percutaneous coronary intervention or coronary artery bypass graft

  11. Revascularization

    Time frame: 5-year follow-up

    Percutaneous coronary intervention or coronary artery bypass graft

  12. Revascularization

    Time frame: 10-year follow-up

    Percutaneous coronary intervention or coronary artery bypass graft

  13. Incident Heart Failure

    Time frame: 2-year follow-up

  14. Incident Heart Failure

    Time frame: 5-year follow-up

  15. Incident Heart Failure

    Time frame: 10-year follow-up

  16. Incident valvular disease

    Time frame: 2-year follow-up

  17. Incident valvular disease

    Time frame: 5-year follow-up

  18. Incident valvular disease

    Time frame: 10-year follow-up

Sponsors and collaborators

Lead sponsor

University Hospital, Gentofte, Copenhagen

Other

Registry information

Official study title

Prevalence and Risk Factors Associated With Cardiac Comorbidity in Inflammatory Arthritis - A Prospective Cohort Study

Acronym: ARTCADIA

Important dates

Study start
2021
Primary completion
2025
Study completion
2033
First posted
Dec 12, 2022
Registry last updated
Feb 28, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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