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

NCT06004154 | Recruiting

• 1 other identifier: GCL_2023_3
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Giant Cell Arteritis

Outcome Measures

Primary Outcomes (4)

• Describe the evolution over time of angiographic-MRI abnormalities at 1 month, 3 months, 6 and 12 months from the diagnosis of Horton's disease.

  thickening (yes/no)

  Day0 to Month12

• Describe the evolution over time of ultrasound abnormalities at 1 month, 3 months, 6 and 12 months from the diagnosis of Horton's disease.

  contrast enhancement (yes/no)

  Day0 to Month12

• Describe the evolution over time of ultrasound abnormalities at 1 month, 3 months, 6 and 12 months from the diagnosis of Horton's disease.

  halo measurement (in mm)

  Day0 to Month12

• Describe the evolution over time of ultrasound abnormalities at 1 month, 3 months, 6 and 12 months from the diagnosis of Horton's disease.

  intima-media thickness measurement (in mm)

  Day0 to Month12

Interventions

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

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

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients treated at the Fondation A de Rothschild Hospital for Horton's disease.

You may qualify if:

• 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.

You may not qualify if:

• Absolute or relative contraindication to MRI (incompatible implantable device, claustrophobia, etc.)
• Hypersensitivity to gadobutrol
• Patient under legal protection
• Pregnant or breast-feeding women

Sponsors & Collaborators

• Fondation Ophtalmologique Adolphe de Rothschild: lead

Study Sites (1)

Hopital Fondation Adolphe de Rothschild

Paris, 75019, France

RECRUITING

MeSH Terms

Conditions

Giant Cell Arteritis

Condition Hierarchy (Ancestors)

Vasculitis, Central Nervous System; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Arteritis; Vasculitis; Skin Diseases, Vascular; Skin Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Central Study Contacts

Amélie Yavchitz, PhD

CONTACT

0148036454; ayavchitz@for.paris

Gaelle Clavel-Refregiers, PhD

CONTACT

01 48 03 62 28; gclavel@for.paris

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 16, 2023
• First Posted: August 22, 2023
• Study Start: November 28, 2023
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): April 1, 2027
• Last Updated: June 4, 2024

Record last verified: 2024-06

Locations

FR (1)