Halo Sign Vanishing Time After Steroids Outbreak in GCA Patients

Last updated: July 1, 2025
Sponsor: Centre Hospitalier le Mans
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Vascular Diseases

Collagen Vascular Diseases

Connective Tissue Diseases

Treatment

Doppler Ultrasound

Clinical Study ID

NCT07060274
CHM-2025/S06/02
  • Ages > 50
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 theresearch).

Exclusion

Exclusion Criteria:

  • Patients with a relapse of Giant Cell Arteritis (GCA).

  • Patients who have previously undergone a temporal artery biopsy (TAB), including forother reasons.

  • Patients who have received oral corticosteroid treatment in the past month or arecurrently on corticosteroid therapy (excluding hydrocortisone or localcorticosteroids).

  • Patients with other types of vasculitis that may constitute a differentialdiagnosis: presence of antibodies against the cytoplasm of neutrophils (ANCA),positive syphilis serology, positivity of an IGRA test (Interferon Gamma ReleaseAssay).

  • Patients having received immunosuppressive treatment or biotherapy in the monthprior to inclusion. If the patient's condition warrants the use of biotherapy orimmunosuppressive treatment, its initiation will be delayed until after Day 7 toavoid interfering with the Doppler procedure.

Study Design

Total Participants: 64
Treatment Group(s): 1
Primary Treatment: Doppler Ultrasound
Phase:
Study Start date:
September 01, 2025
Estimated Completion Date:
October 31, 2027

Connect with a study center

  • Centre Hospitalier du Mans

    Le Mans, Sarthe 72000
    France

    Site Not Available

  • CHU d'Angers

    Angers, 49100
    France

    Site Not Available

  • CHU Caen Normandie

    Caen, 14000
    France

    Site Not Available

  • CHU Dijon - Hôpital François Mitterrand

    Dijon, 21000
    France

    Site Not Available

  • Groupe hospitalier La Rochelle-Ré-Aunis

    La Rochelle, 17000
    France

    Site Not Available

  • CHU Nantes

    Nantes, 44000
    France

    Site Not Available

Map preview placeholder

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.