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Cardiovascular Magnetic resonance imaging and Echocardiography in Rheumatoid Arthritis - Patterns of cardiovascular dysfunction in patients with rheumatoid arthritis.


- candidate number11270
- NTR NumberNTR3317
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR2-mrt-2012
- Secondary IDsNL33959.044.10 / P12-05; CCMO / MST
- Public TitleCardiovascular Magnetic resonance imaging and Echocardiography in Rheumatoid Arthritis - Patterns of cardiovascular dysfunction in patients with rheumatoid arthritis.
- Scientific TitleCardiovascular Magnetic resonance imaging and Echocardiography in Rheumatoid Arthritis - Patterns of cardiovascular dysfunction in patients with rheumatoid arthritis.
- ACRONYMCAMERA-trial
- hypothesisThe main objective of this pilot study is to document cardiovascular dysfunction found in rheumatoid arthritis patients using cardiac imaging techniques echocardiography and cardiac MRI.
- Healt Condition(s) or Problem(s) studiedCardiovascular disease, Rheumatoid arthritis, Echocardiography, Cardiac magnetic resonance imaging
- Inclusion criteriaParticipants in this study will be selected from a large database of RA patients at the rheumatology department. Three groups of patients with rheumafactor positive and anti-CCP positive rheumatoid arthritis will be selected. The first group consists of 30 patients with new onset rheumatoid arthritis (early RA group, < 1 year disease duration). The second group consists of 20 patients with intermediate duration of rheumatoid arthritis (intermediate RA, 5-10 years disease duration, erosive disease, expert based stable low disease activity > 6 months). The third group consists of 30 patients with longstanding rheumatoid arthritis (longstanding RA, > 15 years disease duration, erosive disease, expert based stable low disease activity > 6 months). The age of the study population is 18-75 year
- Exclusion criteriaExclusion criteria: previous CV disease, current smoking, age < 18 or > 75 years, pregnancy, history of kidney dysfunction (GFR < 60 ml/min), hypercholesterolemia/dyslipidemia (total cholesterol > 6.5 mmol/l), history of hypertension (systolic pressure > 140 mmHg, diastolic pressure > 90 mmHg) or use of antihypertensive medication, history of diabetes mellitus (fasting glucose level > 7.0 mmol/l), body mass index > 30 kg/m2, claustrophobia or other exclusion criteria for MRI such as implanted metal materials.
- mec approval receivedyes
- multicenter trialno
- randomisedno
- groupParallel
- Type2 or more arms, non-randomized
- Studytypeobservational
- planned startdate 1-apr-2012
- planned closingdate1-apr-2014
- Target number of participants80
- InterventionsThe main study parameters will be patterns of cardiovascular dysfunction in different groups of RA patients using cardiac imaging techniques echocardiography and cardiac MRI. To assess cardiovascular dysfunction, different variables will be scored including wall motion score, diastolic function, valvular abnormalities, left and right ventricular ejection fraction, left ventricular mass and presence of myocardial fibrosis.
- Primary outcomeWith this pilot study we want to determine parameters that are useful for further follow-up studies in patient with RA in assessing cardiovascular risk with cardiac imaging techniques.
- Secondary outcomeN/A
- Timepoints1. 12 months selecting patients and performing echocardiography and cardiac MRI;
2. 12 months for analysis data and publication of results.
- Trial web siteN/A
- statusplanned
- CONTACT FOR PUBLIC QUERIES E.O.F. Gorselen, van
- CONTACT for SCIENTIFIC QUERIESProf. Dr. C. Birgelen, von
- Sponsor/Initiator Medisch Spectrum Twente
- Funding
(Source(s) of Monetary or Material Support)
Medisch Spectrum Twente
- PublicationsN/A
- Brief summaryPeople with rheumatoid arthritis (RA) have a two- to threefold increased mortality risk compared to the general population. Death is mainly due to cardiovascular diseases, such as myocardial infarction, heart failure and stroke. The pattern of cardiac disease manifestations seems to be different than in the general population. The way cardiovascular disease develops in these patients is greatly unknown.
The main objective of this descriptive pilot study is to document cardiovascular dysfunction found in rheumatoid arthritis patients using cardiac imaging techniques echocardiography and cardiac MRI. The main study parameters will be patterns of cardiovascular dysfunction in different groups of RA patients using cardiac imaging techniques echocardiography and cardiac MRI. To assess cardiovascular dysfunction, different variables will be scored including wall motion score, diastolic function, valvular abnormalities, left and right ventricular ejection fraction, left ventricular mass and presence of myocardial fibrosis. With this pilot study we want to determine parameters that are useful for further follow-up studies in patient with RA in assessing cardiovascular risk with cardiac imaging techniques.
- Main changes (audit trail)
- RECORD2-mrt-2012 - 10-mrt-2012


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