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Post-therapeutic Imaging Evaluation of Patients With Horton's Disease (Giant Cell Arteritis) (EvHortim)

NCT06004154 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 50

Last updated 2024-06-04

No results posted yet for this study

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.

Conditions

  • Giant Cell Arteritis

Interventions

DIAGNOSTIC_TEST

Injected cerebral MRI angiography and ultrasound of the superior aortic trunks, temporal and axillary arteries

Injected cerebral MRI angiography and ultrasound of the superior aortic trunks, temporal and axillary arteries added to the usual follow-up at 1, 3, 6 and 12 months

Sponsors & Collaborators

  • Fondation Ophtalmologique Adolphe de Rothschild

    lead NETWORK

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-11-28
Primary Completion
2027-04-30
Completion
2027-04-30

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06004154 on ClinicalTrials.gov