The Relationship Between Inflammatory ARTritis and CArdiac DIseAse (ARTCADIA)

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Myocardial Infarction; Heart Failure; Stroke; Rheumatoid Arthritis; Ischemic Heart Disease; Inflammatory Arthritis; Heart Failure, Diastolic; Valvular Heart Disease; Heart Failure, Systolic; Spondylitis, Ankylosing; Cardiac Disease; Spondyloarthritis; Axial Spondyloarthritis; Myocardial Dysfunction; Left Ventricular Systolic Dysfunction

• Study Type: Observational
• Enrollment (Actual): 1285

Contacts and Locations

• Study Contact: Name: Morten Sengeløv, MD; Phone Number: +4538673343; Email: morten.sengeloev@regionh.dk

Study Locations

• Denmark
  • Hellerup, Denmark, 2900
    • Department of Cardiology | Center for Translational Cardiology and Pragmatic Randomized Trials (CTCPR) Cardiovascular Non-Invasive Imaging Research Laboratory (CIRL)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

In order to approximate a random sample as accurate as possible, all patients with a diagnosis of rheumatoid Arthritis or axial spondyloarthritis followed in DANBIO in the capital region of Denmark will be eligible to participate. DANBIO is a nationwide registry of patients with rheumatoid Arthritis or axial spondyloarthritis and is approved as a clinical quality registry by the Danish National Board of Health in 2006.

Description

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"

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Inflammatory arthritis patients; Patients with an confirmed diagnosis of rheumatoid arthritis or axial spondyloarthritis.
Participants from the general population; Patients with inflammatory arthritis will be compared to community-dwelling individuals from the 4th and 5th examination round from the Copenhagen City Heart Study (ClinicalTrials.gov identifier NCT02993172, I-Suite no. 03741, National Committee on Health Research Ethics approval HEH-2015-045).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cardiovascular mortality		2-year follow-up
Cardiovascular mortality		5-year follow-up
Cardiovascular mortality		10 year outcome
Admission with congestive heart failure		2-year follow-up
Admission with congestive heart failure		5-year follow-up
Admission with congestive heart failure		10 years
Myocardial infarction		2-year follow-up
Myocardial infarction		5-year follow-up
Myocardial infarction		10 years
Revascularization	Percutaneous coronary intervention or coronary artery bypass graft	2-year follow-up
Revascularization	Percutaneous coronary intervention or coronary artery bypass graft	5-year follow-up
Revascularization	Percutaneous coronary intervention or coronary artery bypass graft	10-year follow-up
Incident Heart Failure		2-year follow-up
Incident Heart Failure		5-year follow-up
Incident Heart Failure		10-year follow-up
Incident valvular disease		2-year follow-up
Incident valvular disease		5-year follow-up
Incident valvular disease		10-year follow-up

Collaborators and Investigators

• Sponsor: University Hospital, Gentofte, Copenhagen

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2021
• Primary Completion (Estimated): March 1, 2025
• Study Completion (Estimated): March 1, 2033

Study Registration Dates

• First Submitted: December 2, 2022
• First Submitted That Met QC Criteria: December 2, 2022
• First Posted (Actual): December 12, 2022

Study Record Updates

• Last Update Posted (Actual): February 28, 2024
• Last Update Submitted That Met QC Criteria: February 27, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Ischemia; Pathologic Processes; Necrosis; Cardiovascular Diseases; Vascular Diseases; Infections; Arteriosclerosis; Arterial Occlusive Diseases; Joint Diseases; Musculoskeletal Diseases; Coronary Disease; Spinal Diseases; Bone Diseases; Spondylarthropathies; Infarction; Heart Murmurs; Bone Diseases, Infectious; Ankylosis; Ventricular Dysfunction; Myocardial Infarction; Heart Failure; Heart Diseases; Coronary Artery Disease; Myocardial Ischemia; Arthritis; Heart Failure, Diastolic; Heart Valve Diseases; Systolic Murmurs; Heart Failure, Systolic; Spondylitis; Spondylarthritis; Spondylitis, Ankylosing; Ventricular Dysfunction, Left; Axial Spondyloarthritis
• Other Study ID Numbers: H-20023771

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No