oPtic Nerve Sheath Evaluation in gianT Cell aRtheritis by UltraSound
ConditionGiant Cell Arteritis (GCA)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age50+
SponsorHôpital NOVO
About this trial
The purpose of this study is to evaluate whether the measure of the optic nerve sheath is a reliable diagnostic marker for giant cell arteritis
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patient with suspected GCA
Patient over 50 years
Disqualifiers
Patient with history of GCA
Patient with a history of polymyalgia rheumatic (PMR) without initial PET scan
Patient with a history of retinal disease, demyelinating disease, or intracranial hypertension
Use of corticosteroids > 0.5mg/kg in the last 2 weeks
Trial design
Design model
Single group
Treatments tested in this trial
orbital ultrasound
Diagnostic testorbital ultrasound at the beginning of the participation, and at 6 months after the inclusion.
Treatment groups
190 Participants
are divided into 1 treatment groupGroup A: Orbital ultrasoundsExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Assess whether the Optic Nerve Sheath Diameter (ONSD) measured by orbital ultrasound serves as an effective diagnostic marker for Giant Cell Arteritis (GCA)
Area under the ROC curve (AUC) of the optic nerve sheath measurements obtained by ultrasound during the enrollment phase, using the final clinical expert diagnosis at 6 months as the reference standard. The clinical expert's evaluation will be blinded to the optic nerve sheath measurements.
Time frame
At the patient enrollment visit and at 6 monthsSecondary outcomes
1
Assess the reproducibility of the optic nerve sheath diameter (ONSD) measurements by ultrasound.
Mean bias according to Bland-Altman analysis, limits of agreement with their confidence intervals, maximum acceptable difference (clinical and statistical difference calculated using the root sum of squares of the coefficients of variation), inter-rater ICC.
Time frame
At the patient enrollment visit and at 6 months2
Evaluate the diagnostic performance of ONSD in GCA.
Sensitivity, specificity, ROC curve inflection point (pathological threshold value), positive predictive value, negative predictive value, positive likelihood ratio, negative likelihood ratio.
Time frame
At the patient enrollment visit and at 6 months3
Study the evolution of ONSD under treatment between M0 and M6 in patients with GCA.
Measurement of the optic nerve sheath diameter (ONSD) by ultrasound at baseline (within 3 days of corticosteroid initiation) in all patients, and at 6 months in patients with GCA.
Time frame
At the patient enrollment visit and at 6 months4
Exploratory evaluation of ONSD according to the presence or absence of extracranial GCA.
Comparison of mean ONSD between subgroups: cranial GCA, extracranial GCA, and GCA-negative patients.
Time frame
At the patient enrollment visit and at 6 monthsSponsors and contacts
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Source ClinicalTrials.gov