The objectives of this study are to investigate the correlation of the handscan measurement with DAS28 and ultrasound measurement of the hands and to investigate the responsiveness to therapy of the handscan device. Also the correlation between the…
ID
Source
Brief title
Condition
- Joint disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study parameters are the results from the handscan measurement,
arterial stiffness as measured with pulse wave velocity and augmentation index,
DAS28 and the ultrasound assessment of the hand joints at all time points
(baseline, 1 month and 4 months).
Secondary outcome
n/a
Background summary
In the last decade, treatment advances in rheumatoid arthritis (RA) have
resulted in a tremendous improvement in therapeutic outcomes. One of these
advances is treat-to-target therapy. However, a valid detection instrument for
disease activity is still necessary. Currently a composite measure called
Disease Activity Score (DAS28) is used for this. However, a new imaging device
called handscan might be an appropriate disease activity detection instrument
as well. Measurements with the handscan are fast and probably less
investigator-dependent. The handscan uses hemodynamics of the smaller vessels
to measure inflammation in the hand joints and therefore a correlation between
the handscan measurement and arterial stiffness, as assessed with pulse wave
velocity, might be present.
Study objective
The objectives of this study are to investigate the correlation of the handscan
measurement with DAS28 and ultrasound measurement of the hands and to
investigate the responsiveness to therapy of the handscan device. Also the
correlation between the handscan and arterial stiffness will be investigated.
Study design
Multi-center longitudinal prospective observational cohort study
Study burden and risks
Due to the observational nature of this study risks are minimal. Handscan
measurement and ultrasonography is non-invasive and safe. Only sampling to
determine ESR and CRP might cause some minor discomfort. From a larger
perspective, the findings from this study will hopefully provide information
that might contribute to better care for rheumatoid arthritis patients.
Dr. Jan van Breemenstraat 2
Amsterdam 1056 AB
NL
Dr. Jan van Breemenstraat 2
Amsterdam 1056 AB
NL
Listed location countries
Age
Inclusion criteria
Rheumatoid arthritis group
- 18 years or older
- Active rheumatoid arthritis in hands or wrists, defined as * 2 swollen hand joints (IP, PIPs and/or MCPs) or * 1 swollen wrist joints;Hypertension group
- 18 years or older
- Patients with hypertension, defined as systolic blood pressure >140 mmHg and/or diastolic blood pressure >90 mmHg or currently on antihypertensive treatment
- No rheumatoid arthritis;Healthy controls group
- 18 years or older
- No hypertension, defined as systolic blood pressure *140 mmHg, diastolic bloodpressure * 90 mmHg and no antihypertensive treatment
- No rheumatoid arthritis
Exclusion criteria
- Surgery in wrist or hand in the preceding 3 months
- Other active concomitant musculoskeletal disease
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 | NL64183.048.17 |
| OMON | NL-OMON20387 |