The Relationship Between Inflammatory ARTritis and CArdiac DIseAse

Stroke Clinical Trial

— ARTCADIA  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05647577
• Other study ID #: H-20023771
• Status: Active, not recruiting
• Start date: January 1, 2021
• Est. completion date: March 1, 2033

Study information

• Verified date: February 2024
• Source: University Hospital, Gentofte, Copenhagen
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1285
• Est. completion date: March 1, 2033
• Est. primary completion date: March 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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"

Related Conditions & MeSH terms

• Arthritis
• Axial Spondyloarthritis
• Cardiac Disease
• Coronary Artery Disease
• Heart Diseases
• Heart Failure
• Heart Failure, Diastolic
• Heart Failure, Systolic
• Heart Valve Diseases
• Inflammatory Arthritis
• Ischemic Heart Disease
• Left Ventricular Systolic Dysfunction
• Myocardial Dysfunction
• Myocardial Infarction
• Myocardial Ischemia
• Rheumatoid Arthritis
• Spondylarthritis
• Spondylitis
• Spondylitis, Ankylosing
• Spondyloarthritis
• Stroke
• Systolic Murmurs
• Valvular Heart Disease
• Ventricular Dysfunction, Left

Locations

Country	Name	City	State
Denmark	Department of Cardiology | Center for Translational Cardiology and Pragmatic Randomized Trials (CTCPR) Cardiovascular Non-Invasive Imaging Research Laboratory (CIRL)	Hellerup

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Gentofte, Copenhagen

Country where clinical trial is conducted

Denmark, 

Outcome

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