Temporal Arteritis Clinical Trials

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Halo Sign Vanishing Time After Steroids Outbreak in GCA Patients

Status: Recruiting
Location: See all (6) locations...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 50
Healthy Volunteers: f
View:

• 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.

• 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).

Locations
Other Locations
France
CHU d'Angers
RECRUITING
Angers
CHU Caen Normandie
NOT_YET_RECRUITING
Caen
CHU Dijon - Hôpital François Mitterrand
NOT_YET_RECRUITING
Dijon
Groupe hospitalier La Rochelle-Ré-Aunis
RECRUITING
La Rochelle
Centre Hospitalier du Mans
RECRUITING
Le Mans
CHU Nantes
RECRUITING
Nantes
Contact Information
Primary
Christelle JADEAU, MD, PhD
cjadeau@ch-lemans.fr
+332 44 71 07 81
Backup
Pierre LOZAC'H, MD
plozach@ch-lemans.fr
+332 43 43 29 12
Time Frame
Start Date: 2026-02-27
Estimated Completion Date: 2028-02
Participants
Target number of participants: 64
Treatments
Experimental: Timeframe for Halo sign resolution on Doppler ultrasound
Doppler ultrasound of temporal arteries at D0, D3 and D7 (+/- D15) after initiation of corticosteroid therapy.
Sponsors
Leads: Centre Hospitalier le Mans

This content was sourced from clinicaltrials.gov