Determining the role of duplex ultrasound in patients with a clinical suspicion for temporal arteritis.Determing the sensitivity, specificity, negative predictive value and positive predictive value of duplex ultrasound in patients with a clinical…
ID
Source
Brief title
Condition
- Autoimmune disorders
- Vascular disorders NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
To determine the sensitivity, specificity, negative predictive value and
positive predictive value of duplex ultrasound in patients with a clinical
suspicion for temporal arteritis.
Secondary outcome
To determine the best hierarchy from the different diagnostic tools. We will
compare the differences in sensitivity on these.
Background summary
Temporal arteritis is a form of vasculitis on which the branches of the
temporal artery superficial are affected. The disease can goes hand in hand
with a large variety of clinical symptoms. In the past, irreversible loss of
sight occur to 35-60% of the patients. Due to fast diagnosing and adequate
treatment, the risk on losing sight is decreased to 7-14%. The disease will be
treated with a large amount of corticosteroids. These steroids can cause
serious side effects. Therefore it is very important to determine if a patient
has the disease or not.
Beside the clinical review, a biopsy of the temporal artery is currently the
gold standard to determine temporal arteritis. Although the biopsy is
relatively save, there a some potential risks like woundinfection, damage on
the facial nerve, CVA due to interruption in the collateral circulation and
necrosis of the temporal scalp. Recently, a number of studies have been done to
determine the value of duplex ultrasound in patients with suspicion for
temporal arteritis. With duplex there is no risk of complications, no use of
ionizing radiation, relatively easy and fast achieveble, and cheap. Most of the
publiced articles confirm the high specificity and a bit lower sensitivity for
duplex on patients with suspicion for temporal arteritis. The question is what
the value of duplex ultrasound is in patients with clinical suspicion for
temporal arteritis in the MCA. It is also the question what the ideal location
for duplex ultrasound is in the diagnostic course for these patients.
Study objective
Determining the role of duplex ultrasound in patients with a clinical suspicion
for temporal arteritis.
Determing the sensitivity, specificity, negative predictive value and positive
predictive value of duplex ultrasound in patients with a clinical suspicion for
temporal arteritis compared to the reference standard. This in comparison with
the diagnostic accuracy of the biopsy compared to the reference standard.
We defined the reference standard as the definitive diagnosis one year after
inclusion, jointly composed by the physicians.
Study design
This is a per prospective study.
Patients with symptoms which could be explained by temporal arteritis will be
included in the study in accordance with the internist of rheumatologist. After
that the following steps will be taken:
1. Clinical a priori estimate for presence of large vessel vasculitis
2. Duplex ultrasound (presence of halo, stenosis and/or occlusion)
3. Questionnaire from patients (complaints, characteristics of the disease, use
of medicin, demographic characteristics)
4. When performed: biopsy
5. The diagnosis after 1 year (blinded evalueted by an internist as well
blinded evalueted by an rheumatologist, and the final diagnosis as drafted by
these clinicians jointly.)
Study burden and risks
Patients are offered a duplex ultrasound and a mini-questionnaire will be
submitted. Therefore we will request half an hour of their time.
Risks for patients are negligible.
Wilhelminalaan 12
Alkmaar 1815JD
NL
Wilhelminalaan 12
Alkmaar 1815JD
NL
Listed location countries
Age
Inclusion criteria
Clinical suspicion of temporal arteritis
Exclusion criteria
Treatment with corticosteroids longer then 1 week
Design
Recruitment
Medical products/devices used
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 | NL46986.094.15 |