ARTCADIA: The Relationship Between Inflammatory ARTritis and CArdiac DIseAse

Sponsor

University Hospital, Gentofte, Copenhagen (Other)

Overall Status

Recruiting

CT.gov ID

NCT05647577

Collaborator

(none)

1,200

Enrollment

Location

145.9

Anticipated Duration (Months)

8.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Inflammatory Arthritis Rheumatoid Arthritis Spondylitis, Ankylosing Axial Spondyloarthritis Spondyloarthritis Heart Failure Ischemic Heart Disease Valvular Heart Disease Left Ventricular Systolic Dysfunction Heart Failure, Systolic Heart Failure, Diastolic Myocardial Infarction Myocardial Dysfunction Cardiac Disease Stroke

Study Design

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

1200 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Jan 1, 2021

Anticipated Primary Completion Date :

Mar 1, 2025

Anticipated Study Completion Date :

Mar 1, 2033

Arms and Interventions

Arm	Intervention/Treatment
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).

Outcome Measures

Primary Outcome Measures

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 [2-year follow-up]
Percutaneous coronary intervention or coronary artery bypass graft
Revascularization [5-year follow-up]
Percutaneous coronary intervention or coronary artery bypass graft
Revascularization [10-year follow-up]
Percutaneous coronary intervention or coronary artery bypass graft
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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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"

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Cardiology \| Center for Translational Cardiology and Pragmatic Randomized Trials (CTCPR) Cardiovascular Non-Invasive Imaging Research Laboratory (CIRL)	Hellerup		Denmark	2900