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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Giant Cell Arteritis
• Intervention / Treatment: Diagnostic test: Injected cerebral MRI angiography and ultrasound of the superior aortic trunks, temporal and axillary arteries

• Study Type: Observational
• Enrollment (Estimated): 50

Contacts and Locations

• Study Contact: Name: Amelie YAVCHITZ, PhD; Phone Number: 0148036454; Email: ayavchitz@for.paris
• Study Contact Backup: Name: Gaelle Clavel-Refregiers, PhD; Phone Number: 01 48 03 62 28; Email: gclavel@for.paris

Study Locations

• France
  • Paris, France, 75019
    • Recruiting
    • Hôpital Fondation Adolphe de Rothschild
    • Contact: Gaelle Clavel-Refregiers, PhD; Phone Number: 01 48 03 62 28; Email: gclavel@for.paris
    • Contact: Amélie Yavchitz Yavchitz, PhD; Phone Number: 0148036454; Email: ayavchitz@for.paris

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Fondation Ophtalmologique Adolphe de Rothschild

Study record dates

Study Major Dates

• Study Start (Actual): November 28, 2023
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): April 1, 2027

Study Registration Dates

• First Submitted: August 16, 2023
• First Submitted That Met QC Criteria: August 16, 2023
• First Posted (Actual): August 22, 2023

Study Record Updates

• Last Update Posted (Actual): June 4, 2024
• Last Update Submitted That Met QC Criteria: June 3, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Skin Diseases; Immune System Diseases; Autoimmune Diseases of the Nervous System; Autoimmune Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Muscular Diseases; Vasculitis; Skin Diseases, Vascular; Vasculitis, Central Nervous System; Polymyalgia Rheumatica; Giant Cell Arteritis; Arteritis
• Other Study ID Numbers: GCL_2023_3

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No