Performance of a Fast-track Pathway for Giant Cell Arteritis Diagnosis
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Performance of the Fast Track Clinic for GCA diagnosis
Study Overview
Brief Summary
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.
Detailed Description
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 :
- an aortic form, i.e. inflammation of the aorta with specific clinical signs (abdominal pain, weight loss, ...)
- a cephalic form with unusual headaches, jaw pain, scalp pain, shoulder and/or pelvic girdle pain, and inflammatory biological signs.
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 50 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patient suspected of GCA
Exclusion Criteria
- •Opposition to the use of their data
Outcomes
Primary Outcomes
Performance of the Fast Track Clinic for GCA diagnosis
Time Frame: From initial GCA suspicion by the clinician to the ultrasound result (up to day 7)
Number of patients for whom the delay between GCA suspicion and ultrasound result is less than 7 days
Secondary Outcomes
- Delay in starting corticosteroids(From initial GCA suspicion by the clinician to corticosteroid prescription (up to 1 month))
- Patients with an alternative diagnosis(From clinical suspicion to the final diagnosis (around 1 month))
- Patients ultrasound negative and pathology positive(From clinical suspicion to pathology results (up to 15 days))
- GCA patients with negative ultrasound and pathology(From clinical suspicion to final diagnosis (around 1 month))