Halo Sign Vanishing Time After Steroids Outbreak in GCA Patients

Not Applicable

Not yet recruiting

• Conditions: Giant Cell Arteritis (GCA); Doppler Ultrasound

• Registration Number: NCT07060274
• Lead Sponsor: Centre Hospitalier le Mans

Brief Summary

Giant cell arteritis (GCA) is a rare disease characterized by vasculitis of the large arterial trunks targeting the thoracic aorta and its dividing branches, affecting adults over the age of 50. Vasculitis lesions cause thickening of the arterial wall, visible on temporal artery biopsy (TAB) or vascular imaging (echo-Doppler, angio-CT, angio-MRI, 18FDG PET-CT). This is a severe disease that can lead to blindness. Early diagnosis is essential, so that steroids therapy can be started as soon as possible to prevent complications. Doppler ultrasonography of the temporal arteries provides rapid, non-invasive diagnostic support. However, the recommendations do not specify how soon temporal artery Doppler should be performed after steroids treatment, except that the halo sign would disappear after about 5 days on steroids. Sensitivity seems to be better when the examination is performed early, but the time taken for the halo sign to disappear is unknown. The investigator suggests that the disappearance of the temporal artery halo sign in GCA patients is observed earlier than D14 of steroids treatment usually reported in the literature. He speculates that the sensitivity of the temporal artery Doppler decreases as early as D3 of steroids treatment, and that beyond D7 it is not useful to perform this examination as its sensitivity becomes too low.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-06-23
• Status Verified: 2025-07
• Study First Submitted QC: 2025-07-01
• Last Update Submitted: 2025-07-01
• Study First Posted: 2025-07-11
• Last Update Posted: 2025-07-11
• Study Start: 2025-09-01
• Primary Completion: 2027-10
• Study Completion: 2027-10-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 64

Inclusion Criteria

• Patients aged 50 and over
• Without legal protection.
• Meeting GCA classification criteria as defined by ACR 2022.
• Newly diagnosed with an indication for corticosteroid treatment.
• Have not yet received corticosteroid treatment for GCA.
• No contraindication to corticosteroid treatment.
• Person affiliated with or benefiting from a social security scheme.
• Free, informed and written consent signed by the participant and the investigator (at the latest on the day of inclusion and before any examination necessary for the research).

Exclusion Criteria

• Patients with a relapse of Giant Cell Arteritis (GCA).
• Patients who have previously undergone a temporal artery biopsy (TAB), including for other reasons.
• Patients who have received oral corticosteroid treatment in the past month or are currently on corticosteroid therapy (excluding hydrocortisone or local corticosteroids).
• Patients with other types of vasculitis that may constitute a differential diagnosis: presence of antibodies against the cytoplasm of neutrophils (ANCA), positive syphilis serology, positivity of an IGRA test (Interferon Gamma Release Assay).
• Patients having received immunosuppressive treatment or biotherapy in the month prior to inclusion. If the patient's condition warrants the use of biotherapy or immunosuppressive treatment, its initiation will be delayed until after Day 7 to avoid interfering with the Doppler procedure.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Number of patients with GCA AND temporal artery Doppler WITH a halo sign on Day 0 of corticosteroid therapy and disappearing on Day 3.	From Day 0 to Day 3 of corticosteroid therapy

Secondary Outcome Measures

Name	Time	Method
Assessment of vasculitis via Doppler on Day 3, Day 7, and Day 15	On Day 3, Day 7 and Day 15 of corticosteroid therapy	With Doppler ultrasound, the following signs of vasculitis will be assessed : Difficulty compressing the temporal artery, Temporal artery occlusion, Temporal artery stenosis, Bilateral or unilateral halo sign and Presence of halo sign on vascular axes other than temporal arteries. The absence or presence of these signs will be reported and used to evaluate the disappearance of the halo sign over time during corticosteroid therapy.
Assessment of other vascular axes on Day 3	On Day 3 of corticosteroid therapy	Number of patients with positive echo-Doppler signs of vasculitis in subclavian, axillary, common/external/internal carotid and vertebral arteries.
Assessment of the number of patients with disappearance of the halo sign on Day 7	On Day 7 of corticosteroid therapy
Assessment of the number of patients with disappearance of the halo sign on Day 15	On Day 15 of corticosteroid therapy
Correlation between histological arteritis and echo-doppler halo sign	On Day 0 of corticosteroid therapy	Number of patients with positive histology on temporal artery biopsy (to be performed at investigator's discretion)
Correlation between C-reactive protein (CRP) kinetics and disappearance of the halo sign	On Day 3 and Day 7 of corticosteroid therapy	Number of patients with positive C-reactive protein (CRP) on Day 3 and Day 7
Correlation between corticosteroid dose and disappearance of halo sign	From Day 0 to Day 15	* Number of patients receiving methylprednisolone bolus; * Number of patients receiving prednisone equivalent greater than or equal to 60mg per day
Number of patients on Tocilizumab with disappearance of Halo sign on Day 15	On Day 15 of corticosteroid therapy

Trial Locations

Locations (6)

Centre Hospitalier du Mans; 🇫🇷 Le Mans, Sarthe, France

CHU d'Angers; 🇫🇷 Angers, France

CHU Caen Normandie; 🇫🇷 Caen, France

CHU Dijon - Hôpital François Mitterrand; 🇫🇷 Dijon, France

Groupe hospitalier La Rochelle-Ré-Aunis; 🇫🇷 La Rochelle, France

CHU Nantes; 🇫🇷 Nantes, France