Halo-ASteroid Effect on Halo Sign in GCA Patients' Diagnostic Study
This study investigates how corticosteroid therapy affects the 'halo sign' in patients with Giant Cell Arteritis (GCA) who undergo temporal artery Doppler testing.
Doppler Ultrasound
Arteritis+13
+ Autoimmune Diseases
+ Brain Diseases
Diagnostic Study
Summary
Study start date: September 1, 2025
Actual date on which the first participant was enrolled.This study focuses on understanding the best timing for using Doppler ultrasonography to diagnose giant cell arteritis (GCA) in people over 50. GCA is a serious condition that causes inflammation in large arteries, potentially leading to blindness if not treated quickly. Steroids are commonly used to manage this condition, and early diagnosis is crucial for effective treatment. The study aims to determine how soon after starting steroid treatment the halo sign, a key indicator seen on a Doppler scan, disappears. Current guidelines suggest this sign fades after about five days, but the exact timeline is uncertain, which is what this study seeks to clarify. Participants will undergo Doppler ultrasonography of their temporal arteries at different times after starting steroid treatment. This non-invasive test will help researchers observe when the halo sign disappears. The study will evaluate whether the sensitivity of the Doppler test decreases early in the treatment process, potentially as early as three days after starting steroids. This information could help doctors know the optimal time to conduct this test to ensure accurate diagnosis, potentially improving the management of GCA and preventing complications like blindness.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.64 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Diagnostic Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 50 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
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 Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.One single intervention group is designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 6 locations
CHU d'Angers
Angers, FranceCHU Caen Normandie
Caen, FranceCHU Dijon - Hôpital François Mitterrand
Dijon, France