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Clinical Trials/NCT05647577
NCT05647577
Active, not recruiting
Not Applicable

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

University Hospital, Gentofte, Copenhagen1 site in 1 country1,285 target enrollmentJanuary 1, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Inflammatory Arthritis
Sponsor
University Hospital, Gentofte, Copenhagen
Enrollment
1285
Locations
1
Primary Endpoint
Myocardial infarction
Status
Active, not recruiting
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 1, 2021
End Date
March 1, 2033
Last Updated
2 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
University Hospital, Gentofte, Copenhagen
Responsible Party
Principal Investigator
Principal Investigator

Tor Biering-Sørensen

Professor in Translational Cardiology and Pragmatic Randomized Trials

University Hospital, Gentofte, Copenhagen

Eligibility Criteria

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"

Outcomes

Primary Outcomes

Myocardial infarction

Time Frame: 10 years

Cardiovascular mortality

Time Frame: 10 year outcome

Admission with congestive heart failure

Time Frame: 10 years

Revascularization

Time Frame: 10-year follow-up

Percutaneous coronary intervention or coronary artery bypass graft

Incident Heart Failure

Time Frame: 10-year follow-up

Incident valvular disease

Time Frame: 10-year follow-up

Study Sites (1)

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