An observational study in Giant Cell Arteritis (GCA), sponsored by Groupe Hospitalier de la Rochelle Ré Aunis. Recruiting at 1 site in France. Open to participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2025-06-20.
Sponsored by Groupe Hospitalier de la Rochelle Ré Aunis · Observational
Giant cell arteritis is a vasculitis, i.e. inflammation of the artery walls, which generally affects people over the age of 50. Diagnosis can be long and difficult, as the clinical signs are not specific (headache, pain in the jaw, scalp, shoulders and/or pelvis, abdominal pain, weight loss, etc.), but it must be made quickly, given the risk of complications.
The reference method for diagnosis was initially based on clinical suspicion and analysis of a "piece of temporal artery" (biopsy) performed in the operating theatre under local anaesthetic. Since the mid-1990s, improvements in ultrasound techniques have made it possible to identify a sign, known as a halo, on the temporal arteries that is typical of patients with Giant Cell Arteritis. A prospective multicenter study published in 2024 demonstrated that, in patients with a clinical suspicion of Giant Cell Arteritis, if a halo was found on both temporal arteries by ultrasound, there was no need for a biopsy. This study is at the origin of a change in practices in the diagnosis and care of patients suffering from this disabling disease.
To facilitate early diagnosis, a fast-track pathway has been set up. The aim is to make a rapid diagnosis, thereby reducing the risk of after-effects, shortening the length of hospital stays, considering outpatient treatment and limiting the number of biopsies.
The investigators propose to evaluate the performance of this fast-track pathway.
Giant Cell Arteritis (GCA) or temporal arteritis is a systemic vasculitis (inflammation of the artery walls) that generally affects people over 50 years old, with a peak frequency between 70 and 80 years. The diagnosis is sometimes long and difficult to make due to non-specific clinical signs but must be rapid because of the risk of arterial occlusion that can lead to vision loss or stroke.
Two GCA presentations can be detected :
The reference method for diagnosis has been based on clinical presumption. The presence of an inflammatory syndrome in biology and the analysis of a temporal artery biopsy.
Since the mid-1990s, the improvement of ultrasound techniques, particularly with the appearance of high frequency probes, made it possible to detect inflammation of the temporal arteries in some cases. Each center published retrospective studies with the aim of avoiding biopsy but without really allowing the modification of clinical practices.
A prospective multicenter study (doi: 10.7326/M23-3417) published in 2024 proved that in patients with high clinical probability of GCA, in case of bilateral positivity on temporal artery ultrasound (hypoechoic halo) it was not necessary to resort to a biopsy.
When the ultrasound of bilateral arteries (particularly temporal and axillary) showed an abnormality such as a halo (inflammation), the diagnosis was made and did not require a biopsy.
When the ultrasound was negative (or only present on one artery or another arterial axis), biopsy was necessary. In 50% of cases, the biopsy result was negative. Among these negative cases, a certain number were nevertheless retained as Giant Cell Arteritis, according to the clinician's assessment, and others were subjected to differential diagnoses.
While with a biopsy the time to perform the procedure and obtain its interpretation was 10 days, ultrasound only requires one day to make a diagnosis.
This study is at the origin of a change in diagnosing and treating patients with this Giant Cell Arteritis.
In order to facilitate early diagnosis, a fast-track pathway has been set up based on the model published in 2024 (doi: 10.26635/6965.6376).
The investigators propose to evaluate the performance of this fast-track clinic.
147 studies on the registry are indexed under Giant Cell Arteritis; 49 are open to participants now.
This study's planned enrollment of 100 is below the median of 128 across 78 observational studies indexed under Giant Cell Arteritis.
Browse Giant Cell Arteritis studies →Groupe Hospitalier de la Rochelle Ré Aunis is the lead sponsor of 22 studies on the registry; 6 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients from North Charente-Martime with suspicion of GCA that are sent to la Rochelle hospital for fast track diagnosis
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Patient over 50 years old suspected of Giant Cell Arteritis and presenting at least one of the following signs: Visual symptoms * Transient vision loss (amaurosis) * Anterior or posterior ischemic optic neuropathy * Occlusion of the central retinal artery and/or its branches * Diplopia due to paralysis of the oculomotor muscles * Ocular ischemic syndrome Suggestive signs and symptoms: * Recent headaches \< 4 months * Jaw claudication * Scalp tenderness * Abnormal temporal artery examination - beaded appearance, prominence, widening, tenderness * Elevated C-reactive protein ≥ 10 mg/l Systemic symptoms: * Fever * Anemia * Upper limb claudication * Polymyalgia rheumatica Suggestive imaging result * Positive positron emission computed tomography scan * CT scan aortitis
Performance of the Fast Track Clinic for GCA diagnosis
Number of patients for whom the delay between GCA suspicion and ultrasound result is less than 7 days
Time frame: From initial GCA suspicion by the clinician to the ultrasound result (up to day 7)
Delay in starting corticosteroids
The duration between suspicion of GCA and corticosteroid prescription
Time frame: From initial GCA suspicion by the clinician to corticosteroid prescription (up to 1 month)
Patients with an alternative diagnosis
Number of patients with an alternative diagnosis
Time frame: From clinical suspicion to the final diagnosis (around 1 month)
Patients ultrasound negative and pathology positive
The number of ultrasound negative patients with a positive result according to pathology analysis of temporal artery biopsy
Time frame: From clinical suspicion to pathology results (up to 15 days)
GCA patients with negative ultrasound and pathology
Number of patients for whom Doppler ultrasound and biopsy analysis results are negative but who are considered to have GCA by the clinician
Time frame: From clinical suspicion to final diagnosis (around 1 month)
Plan to share: Yes — All of the individual participant data collected during the study will be shared after deidentification. Study protocol and statistical analysis plan will be available. Data will be available immediately following publication. Researchers who provide a methodologically sound proposal will have access to the data. Data will be available at www.recherche.data.gouv.fr
Supporting information: Study protocol, Statistical analysis plan
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