Primary objective: To investigate whether AS patients have increased signs of microvascular abnormalities of the retina, compared with healthy controls.Secondary objectives: to investigate:1. the peripheral microvascular function in AS patients,…
ID
Source
Brief title
Condition
- Coronary artery disorders
- Autoimmune disorders
- Arteriosclerosis, stenosis, vascular insufficiency and necrosis
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study parameters are the aspects of the retinal arterioles and
venules, identified with SIVA (Singapore I Vessel Assessment) software of the
fundus photos and the retinal thickness and vascular density on (angio) ocular
coherence tomography.
Secondary outcome
The secondary parameter is the reactive hyperaemia index (RHI), measured with
EndoPAT (and calculated automatically by its software). Furthermore, patient
characteristics, AS disease characteristics, disease activity parameters,
medication, cardiovascular risk factors and diseases, physicical exercise,
profession (white or blue collar), laboratory measurements (CRP, ESR, lipid
profile) and anthropometric measurements (blood pressure, BMI, arthritis,
enthesitis) will be collected.
Background summary
Ankylosing spondylitis (AS) is a rheumatic disease that causes chronic
inflammation of the spinal- and sacroiliac joints and is associated with an
increased risk of cardiovascular diseases. Accumulating evidence suggests a
pivotal role of systemic inflammation in endothelial dysfunction, microvascular
abnormalities and eventually the development of cardiovascular disease (CVD).
However, in daily practice the early recognition of developing cardiovascular
diseases remains a challenge. The retinal vasculature is very accessible for
non-invasive visualization and provides a unique opportunity to study early
structural changes of the microcirculation. The association between
abnormalities of the retinal arterioles and venules and current and future
cardiovascular diseases have been extensively reported. Few studies have
reported on abnormalities of the retinal vasculature in chronic inflammatory
diseases.
Study objective
Primary objective: To investigate whether AS patients have increased signs of
microvascular abnormalities of the retina, compared with healthy controls.
Secondary objectives: to investigate:
1. the peripheral microvascular function in AS patients, measured with reactive
hyperemia peripheral arterial tonometry (EndoPAT).
2. whether there is a relation between the retinal and peripheral microvascular
abnormalities.
3. gender differences in microvascular abnormalities.
4. the correlation between AS disease activity and microvascular abnormalities.
5. the association between the cardiovascular risk score and retinal vascular
caliber for both patients and controls.
6. differences in retinal vascular measurements between two types of fundus
cameras
Study design
cross sectional case-control design in which AS patients are compared with
gender- and age-matched healthy controls. Fifty-five patients and 110 controls
will be included and a male-female ratio of 1:1 will be pursued. All AS
patients undergo rheumatologic (short interview, physical examination, daily
care questionnaires), laboratory (regular tests according to standard care),
ocular assessment (inspection of the anterior eye chamber, fundus photos and a
normal and angio ocular coherence tomography scan (no Röntgen radiation)) and
EndoPAT assessment (specifically for this study) only once, on the same day.
The ophthalmologic data of the control group was already collected for other
study purposes.
Study burden and risks
The study exists of only one study visit that will approximately take 3 hours
in total. No invasive diagnostics will be used. The risk and burden of the
study procedures (ocular examination and EndoPAT assessment) is considered to
be negligible. The aspects that may cause (some) discomfort to the subjects are
a blurred vision during 1-4 hours after ocular assessment due to mydriatic eye
drops (standard procedure) and transient (maximally 5 minutes) paraesthesia of
one of the hands during the EndoPAT procedure.
De boelelaan 1117
Amsterdam 1081 HV
NL
De boelelaan 1117
Amsterdam 1081 HV
NL
Listed location countries
Age
Inclusion criteria
* Age 50-75 years
* Diagnosis of AS according to the 1984 modified New York Criteria
Exclusion criteria
* Diagnosis of diabetes mellitus.
* History of an ischaemic stroke or cerebral haemorrhage.
* History or evidence of glaucoma, significant cataract or cataract surgery in the 6 months prior.
* Active anterior uveitis during the study visit
* Rheumatic disease other than related to AS (so: psoriatic arthritis and Inflammatory Bowel Disease are allowed)
* Current use of systemic and/or ocular corticosteroids
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
CCMO | NL66784.048.18 |