Inflammatory ArthritisARTCADIANCT05647577
The Relationship Between Inflammatory ARTritis and CArdiac DIseAse
An observational study of Inflammatory Arthritis and Rheumatoid Arthritis, run by University Hospital, Gentofte, Copenhagen at 1 site in Denmark.
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Inflammatory Arthritis, Rheumatoid Arthritis, Spondylitis, Ankylosing
- How many people
- 1,285 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Jan 2021to 1 Mar 2033
- How long will I take part?
- 10 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Persons with a diagnosis of with a confirmed diagnosis of rheumatoid Arthritis or axial spondyloarthritis
Who cannot join
- Persons not able to cooperate
- Persons unable understand and sign "informed consent"
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Department of Cardiology | Center for Translational Cardiology and Pragmatic Randomized Trials (CTCPR) Cardiovascular Non-Invasive Imaging Research Laboratory (CIRL)
Hellerup, 2900
About this study
Official title: 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
Read more
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.
- Conditions
- Inflammatory Arthritis, Rheumatoid Arthritis, Spondylitis, Ankylosing, Axial Spondyloarthritis, Spondyloarthritis, Heart Failure
- Medical subject headings
- Arthritis, Arthritis, Rheumatoid, Spondylitis, Ankylosing, Axial Spondyloarthritis, Spondylarthritis, Heart Failure, Myocardial Ischemia, Heart Valve Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Cardiovascular mortality
Measured: 2-year follow-up
Cardiovascular mortality
Measured: 5-year follow-up
Cardiovascular mortality
Measured: 10 year outcome
Admission with congestive heart failure
Measured: 2-year follow-up
Admission with congestive heart failure
Measured: 5-year follow-up
Admission with congestive heart failure
Measured: 10 years
Myocardial infarction
Measured: 2-year follow-up
Myocardial infarction
Measured: 5-year follow-up
Myocardial infarction
Measured: 10 years
Revascularization
Percutaneous coronary intervention or coronary artery bypass graft
Measured: 2-year follow-up
Revascularization
Percutaneous coronary intervention or coronary artery bypass graft
Measured: 5-year follow-up
Revascularization
Percutaneous coronary intervention or coronary artery bypass graft
Measured: 10-year follow-up
Incident Heart Failure
Measured: 2-year follow-up
Incident Heart Failure
Measured: 5-year follow-up
Incident Heart Failure
Measured: 10-year follow-up
Incident valvular disease
Measured: 2-year follow-up
Incident valvular disease
Measured: 5-year follow-up
Incident valvular disease
Measured: 10-year follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2022
- Study start1 Jan 2021
- Primary completion1 Mar 2025 (estimated)
- Study completion1 Mar 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inflammatory ArthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,285 participants (actual)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- University Hospital, Gentofte, Copenhagen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tor Biering-Sørensen, University Hospital, Gentofte, Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05647577
- Sponsor's protocol ID
- H-20023771
- Acronym
- ARTCADIA
- Status last verified
- Feb 2024
- First submitted
- 2 Dec 2022
- Last updated
- 28 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence and Risk Factors Associated With Cardiac Comorbidity in Inflammatory Arthritis - A Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT05647577
- Acronym / sponsor ID
- ARTCADIA / H-20023771
- Conditions
- Inflammatory Arthritis, Rheumatoid Arthritis, Spondylitis, Ankylosing, Axial Spondyloarthritis, Spondyloarthritis, Heart Failure
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 1,285 participants (actual)
- Lead sponsor
- University Hospital, Gentofte, CopenhagenUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 1 Mar 2025 (estimated)
- Study completion
- 1 Mar 2033 (estimated)
- First posted
- 12 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 10 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- Persons with a diagnosis of with a confirmed diagnosis of rheumatoid Arthritis or axial spondyloarthritis
Key exclusion criteria (2 listed)
- Persons not able to cooperate
- Persons unable understand and sign "informed consent"
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Cardiovascular mortality
Time frame: 2-year follow-up
Cardiovascular mortality
Time frame: 5-year follow-up
Cardiovascular mortality
Time frame: 10 year outcome
Admission with congestive heart failure
Time frame: 2-year follow-up
Admission with congestive heart failure
Time frame: 5-year follow-up
Admission with congestive heart failure
Time frame: 10 years
Myocardial infarction
Time frame: 2-year follow-up
Myocardial infarction
Time frame: 5-year follow-up
Myocardial infarction
Time frame: 10 years
Revascularization
Time frame: 2-year follow-up
Percutaneous coronary intervention or coronary artery bypass graft
Revascularization
Time frame: 5-year follow-up
Percutaneous coronary intervention or coronary artery bypass graft
Revascularization
Time frame: 10-year follow-up
Percutaneous coronary intervention or coronary artery bypass graft
Incident Heart Failure
Time frame: 2-year follow-up
Incident Heart Failure
Time frame: 5-year follow-up
Incident Heart Failure
Time frame: 10-year follow-up
Incident valvular disease
Time frame: 2-year follow-up
Incident valvular disease
Time frame: 5-year follow-up
Incident valvular disease
Time frame: 10-year follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Inflammatory Arthritis and Rheumatoid Arthritis, run by University Hospital, Gentofte, Copenhagen at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 28 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cardiovascular mortality (time frame: 2-year follow-up). The study lists 18 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2024.