Performance of a Fast-track Pathway for Giant Cell Arteritis Diagnosis

NCT06742671 | Recruiting

• 1 other identifier: P02/043
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Giant Cell Arteritis (GCA)

Keywords

diagnostic test; ultrasonography, Doppler, color; temporal arteries, biopsy; fast track clinic

Outcome Measures

Primary Outcomes (1)

• 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

  From initial GCA suspicion by the clinician to the ultrasound result (up to day 7)

Secondary Outcomes (4)

• 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)

Study Arms (1)

Patient suspected of Giant Cell Arteritis

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

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients from North Charente-Martime with suspicion of GCA that are sent to la Rochelle hospital for fast track diagnosis

You may qualify if:

• Patient suspected of GCA

You may not qualify if:

• Opposition to the use of their data

Sponsors & Collaborators

• Groupe Hospitalier de la Rochelle Ré Aunis: lead

Study Sites (1)

Groupe Hospitalier de la Rochelle Ré Aunis

La Rochelle, France

RECRUITING

Related Publications (2)

• van Dantzig P, White D, Kurz J, Ming C, Kamalaksha S, Quincey V. Performance of a fast-track pathway for giant cell arteritis in Waikato, Aotearoa New Zealand. N Z Med J. 2024 Mar 22;137(1592):31-42. doi: 10.26635/6965.6376.

  PMID: 38513202 BACKGROUND

• Denis G, Espitia O, Allix-Beguec C, Dieval C, Lorcerie F, Gombert B, Pouget-Abadie X, Toquet C, Agard C, Raimbeau A, Gautier G, Goujon JM, Durand G, Thollot-Karolewicz C, Lormeau C, Grados A, Grenot-Mercier A, El-Khoury R, Riche A, Hospital F, Visee S, Auriault ML, Landron C, Martin M, Roncato C. Diagnostic Strategy Using Color Doppler Ultrasound of Temporal Arteries in Patients With High Clinical Suspicion of Giant Cell Arteritis : A Prospective Cohort Study. Ann Intern Med. 2024 Jun;177(6):729-737. doi: 10.7326/M23-3417. Epub 2024 May 7.

  PMID: 38710093 BACKGROUND

MeSH Terms

Conditions

Giant Cell Arteritis

Condition Hierarchy (Ancestors)

Vasculitis, Central Nervous System; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Arteritis; Vasculitis; Skin Diseases, Vascular; Skin Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Christophe RONCATO, MD

  Groupe Hospitalier de la Rochelle Ré Aunis

  STUDY DIRECTOR

Central Study Contacts

Caroline Allix-Béguec, Ph.D.

CONTACT

+33516494246; caroline.allix-beguec@ght-atlantique17.fr

Cécile Duchiron, Ph.D.

CONTACT

cecile.duchiron@ght-atlantique17.Fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 13, 2024
• First Posted: December 19, 2024
• Study Start: February 14, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): March 31, 2027
• Last Updated: June 20, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP

Locations

FR (1)