Ignite Creation Date:
2024-05-06 @ 6:40 PM
Last Modification Date:
2024-10-26 @ 2:52 PM
Study NCT ID:
NCT05749094
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-09-22
First Post:
2023-02-18
Brief Title:
Optic Nerve Sheath Ultrasound in Giant Cell Arteritis
Sponsor:
Hopital du Sacre-Coeur de Montreal
Organization:
Hopital du Sacre-Coeur de Montreal
Study Overview
Official Title:
The Sonographic Assessment of the Optic Nerve Sheath in Giant Cell Arteritis
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SONIC-GCA
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None