Optic Nerve Sheath Ultrasound in Giant Cell Arteritis
Not yet recruiting
- Conditions
- Optic Neuropathy, IschemicAnterior Ischemic Optic NeuropathyGiant Cell Arteritis
- Registration Number
- NCT05749094
- Lead Sponsor
- Hopital du Sacre-Coeur de Montreal
- Brief Summary
The Sonographic Assessment of the Optic Nerve Sheath in GCA (SONIC-GCA) study will: 1) assess the performance, in terms of sensitivity and specificity, of the optic nerve sheath diameter (ONSD) to detect new-onset, active GCA; 2) evaluate the intra- and interobserver reliability of ONSD measures; 3) establish if an association exists between the ONSD and the presence of GCA retinal findings; and 4) evaluate if the ONSD is a dynamic biomarker of GCA remission and relapse.
- Detailed Description
SONIC-GCA is a prospective cohort and validation study conducted in centers of the Canadian Vasculitis Research Network (CanVasc).
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 260
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Mean difference in ONSD on ultrasound between participants with and without GCA Baseline
- Secondary Outcome Measures
Name Time Method Performance of the ONSD on ultrasound to identify GCA, in terms of sensitivity, specificity, positive and negative predictive values, and accuracy. Baseline The Paired mean difference in ONSD during the follow-up period, based on changes in disease activity in GCA patients-from new-onset disease to clinical remission and from clinical remission to the first relapse (if any). Months 3 - 24
Trial Locations
- Locations (1)
Vasculitis Clinic, Hopital du Sacre-Coeur de Montreal
🇨🇦Montreal, Quebec, Canada