The main objective of the study is to document cardiovascular dysfunction found in rheumatoid arthritis and gout patients using cardiac imaging techniques echocardiography and cardiac MRI.
ID
Source
Brief title
Condition
- Cardiac disorders, signs and symptoms NEC
- Joint disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study parameters will be patterns of cardiovascular dysfunction in
different groups of RA patients and gout using cardiac imaging techniques. 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 and chronic gout in assessing
cardiovascular risk with cardiac imaging techniques.
Secondary outcome
Not applicable.
Background summary
People 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. People with chronic gout also have an
increased risk for cardiovascular mortality.
Study objective
The main objective of the study is to document cardiovascular dysfunction found
in rheumatoid arthritis and gout patients using cardiac imaging techniques
echocardiography and cardiac MRI.
Study design
Descriptive pilot study.
Study burden and risks
Patients will undergo cardiac magnetic resonance imaging (MRI) and
echocardiography on two different days. During cardiac MRI, patients will
receive intravenously contrast in order to be able to differentiate various
types of cardiac pathology. There is a hypothetical risk of nephrogenic
systemic fibrosis (NSF) associated with gadolium-based contrast used in MRI.
NSF occurs exclusively in patients with kidney failure and as patients selected
for this study will only be allowed to participate if renal function is within
normal limits, it is highly unlikely to occur. The incidence of NSF due to the
contrast used in this study is 0% according to the manufacturer. MRI-scanning
can be unpleasant to people with claustrophobia. Patients with significant
claustrophobia will be excluded from participation in this study. Furthermore,
patients who are pregnant or have metal implants will be excluded.
Haaksbergerstraat 55
Enschede 7513 ER
NL
Haaksbergerstraat 55
Enschede 7513 ER
NL
Listed location countries
Age
Inclusion criteria
rheumatoid arthritis patients with anti-CCP+ and RF+ laboratory results
patients with punctate proven gout
Exclusion criteria
male gender
previous cardiovascular disease
current smoking
history of kidney dysfunction, hypertension or diabetes mellitus
claustrophobia
body mass index > 30 kg/m2
pregnancy
metal impants
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL33959.044.10 |
| OMON | NL-OMON21327 |