Ignite Creation Date:
2024-05-06 @ 7:24 PM
Last Modification Date:
2024-10-26 @ 3:06 PM
Study NCT ID:
NCT06004154
Status:
RECRUITING
Last Update Posted:
2024-06-04
First Post:
2023-08-16
Brief Title:
Post-therapeutic Imaging Evaluation of Patients With Hortons Disease Giant Cell Arteritis EvHortim
Sponsor:
Fondation Ophtalmologique Adolphe de Rothschild
Organization:
Fondation Ophtalmologique Adolphe de Rothschild
Study Overview
Official Title:
Post-therapeutic Imaging Evaluation of Patients With Hortons Disease Giant Cell Arteritis
Status:
RECRUITING
Status Verified Date:
2024-06
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:
EvHortim
Brief Summary:
Giant cell arteritis GCA also known as Hortons disease is an inflammatory arteritis of the large and medium-sized arteries with an estimated incidence of 178100000 in people over 50
The disease presents potential ophthalmological neurological cardiac and aortic vascular complications making diagnosis an emergency in cases of suspected Hortons disease
only corticosteroid therapy started as early as possible can prevent these complications
Diagnosis has historically relied on temporal artery biopsy but the recent ACREULAR 2022 classification criteria propose alternatives to this invasive examination in particular imaging tests such as temporal artery ultrasound and PET scans Although not included in these latest recommendations high-definition wall MRI can also provide arguments in favor of this diagnosis and avoid the need for a temporal artery biopsy the sensitivity of which is only 75 The investigators recently demonstrated in a prospective cohort that wall MRI possibly coupled with temporal artery ultrasound or retinal angiography was far superior to temporal artery biopsy in diagnostic performance
The main limitation of these imaging tests is the lack of data in the literature on the evolution of abnormalities over time and in particular after initiation of oral corticosteroid therapy This uncertainty makes it difficult to use these examinations to monitor disease activity particularly in cases of suspected relapse a frequent situation in which the clinician is regularly put at fault due to an often frustrating symptomatology and the possible absence of a frank biological inflammatory syndrome
The investigators propose to conduct a study aimed at describing the evolution of cranial vessel wall abnormalities on wall MRI and ultrasound by systematically repeating these examinations at 1 month 3 months from the initial MRI performed at diagnosis in addition to the follow-up performed as part of care at 6 and 12 months from diagnosis In the event of a relapse in the intervening period a new MRI scan can be performed and compared with the most recent MRI scan to look for evidence of disease activity
The disease presents potential ophthalmological neurological cardiac and aortic vascular complications making diagnosis an emergency in cases of suspected Hortons disease
only corticosteroid therapy started as early as possible can prevent these complications
Diagnosis has historically relied on temporal artery biopsy but the recent ACREULAR 2022 classification criteria propose alternatives to this invasive examination in particular imaging tests such as temporal artery ultrasound and PET scans Although not included in these latest recommendations high-definition wall MRI can also provide arguments in favor of this diagnosis and avoid the need for a temporal artery biopsy the sensitivity of which is only 75 The investigators recently demonstrated in a prospective cohort that wall MRI possibly coupled with temporal artery ultrasound or retinal angiography was far superior to temporal artery biopsy in diagnostic performance
The main limitation of these imaging tests is the lack of data in the literature on the evolution of abnormalities over time and in particular after initiation of oral corticosteroid therapy This uncertainty makes it difficult to use these examinations to monitor disease activity particularly in cases of suspected relapse a frequent situation in which the clinician is regularly put at fault due to an often frustrating symptomatology and the possible absence of a frank biological inflammatory syndrome
The investigators propose to conduct a study aimed at describing the evolution of cranial vessel wall abnormalities on wall MRI and ultrasound by systematically repeating these examinations at 1 month 3 months from the initial MRI performed at diagnosis in addition to the follow-up performed as part of care at 6 and 12 months from diagnosis In the event of a relapse in the intervening period a new MRI scan can be performed and compared with the most recent MRI scan to look for evidence of disease activity
Detailed Description:
None
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