Halo Sign Vanishing Time After Steroids Outbreak in GCA Patients

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age50+
SponsorCentre Hospitalier le Mans

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

Patients aged 50 and over

Without legal protection.

Meeting GCA classification criteria as defined by ACR 2022 with the presence of a halo sign-unilateral or bilateral-on Doppler ultrasound of the temporal artery.

Newly diagnosed with an indication for corticosteroid treatment.

Disqualifiers

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).

Trial design

Design model

Single group

Treatments tested in this trial

  • Doppler Ultrasound

    Procedure/Surgery

    Doppler ultrasound of temporal arteries at D0, D3 and D7 (+ D15 if halo detected at D7) after initiation of corticosteroid therapy.

Treatment groups

64 Participants
are divided into 1 treatment group
Group A: Timeframe for Halo sign resolution on Doppler ultrasoundExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
From Day 0 to Day 3 of corticosteroid therapy

Secondary outcomes

1

Assessment of vasculitis via Doppler on Day 3, Day 7, and Day 15

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.

Time frame
On Day 3, Day 7 and Day 15 of corticosteroid therapy
2

Assessment of other vascular axes on Day 3

Number of patients with positive echo-Doppler signs of vasculitis in subclavian, axillary, common/external/internal carotid and vertebral arteries.

Time frame
On Day 3 of corticosteroid therapy
3

Assessment of the number of patients with disappearance of the halo sign on Day 7

Time frame
On Day 7 of corticosteroid therapy
4

Assessment of the number of patients with disappearance of the halo sign on Day 15

Time frame
On Day 15 of corticosteroid therapy

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.