NCT06004154 Post-therapeutic Imaging Evaluation of Patients With Horton's Disease (Giant Cell Arteritis) (EvHortim)
| NCT ID | NCT06004154 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Fondation Ophtalmologique Adolphe de Rothschild |
| Condition | Giant Cell Arteritis |
| Study Type | OBSERVATIONAL |
| Enrollment | 50 participants |
| Start Date | 2023-11-28 |
| Primary Completion | 2027-04 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 50 participants in total. It began in 2023-11-28 with a primary completion date of 2027-04.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Giant cell arteritis (GCA), also known as Horton's disease, is an inflammatory arteritis of the large and medium-sized arteries, with an estimated incidence of 17.8/100,000 in people over 50. The disease presents potential ophthalmological, neurological, cardiac and aortic vascular complications, making diagnosis an emergency in cases of suspected Horton's disease. only corticosteroid therapy started as early as possible can prevent these complications. Diagnosis has historically relied on temporal artery biopsy, but the recent ACR/EULAR 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.
Eligibility Criteria
Inclusion Criteria: * Patient aged 50 and over * Having received informed consent to participate in the study * Affiliated or beneficiary of a social insurance scheme * Patients with giant cell arteritis according to ACR/EULAR 2022 criteria * Diagnosed with MRI and ultrasound. Exclusion Criteria: * Absolute or relative contraindication to MRI (incompatible implantable device, claustrophobia, etc.) * Hypersensitivity to gadobutrol * Patient under legal protection * Pregnant or breast-feeding women
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06004154 clinical trial?
This trial is open to participants of all sexes, aged 50 Years or older, studying Giant Cell Arteritis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06004154 currently recruiting?
Yes, NCT06004154 is actively recruiting participants. Contact the research team at ayavchitz@for.paris for enrollment information.
Where is the NCT06004154 trial being conducted?
This trial is being conducted at Paris, France.
Who is sponsoring the NCT06004154 clinical trial?
NCT06004154 is sponsored by Fondation Ophtalmologique Adolphe de Rothschild. The trial plans to enroll 50 participants.