Performance of a Fast-track Pathway for Giant Cell Arteritis Diagnosis (QuickDx-GCA)

June 17, 2025 updated by: Groupe Hospitalier de la Rochelle Ré Aunis

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.

Study Overview

Status

Recruiting

Conditions

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.

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.

Study Type

Observational

Enrollment (Estimated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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

Description

Inclusion Criteria:

  • Patient suspected of GCA

Exclusion Criteria:

  • Opposition to the use of their data

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
From initial GCA suspicion by the clinician to the ultrasound result (up to day 7)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Delay in starting corticosteroids
Time Frame: From initial GCA suspicion by the clinician to corticosteroid prescription (up to 1 month)
The duration between suspicion of GCA and corticosteroid prescription
From initial GCA suspicion by the clinician to corticosteroid prescription (up to 1 month)
Patients with an alternative diagnosis
Time Frame: From clinical suspicion to the final diagnosis (around 1 month)
Number of patients with an alternative diagnosis
From clinical suspicion to the final diagnosis (around 1 month)
Patients ultrasound negative and pathology positive
Time Frame: From clinical suspicion to pathology results (up to 15 days)
The number of ultrasound negative patients with a positive result according to pathology analysis of temporal artery biopsy
From clinical suspicion to pathology results (up to 15 days)
GCA patients with negative ultrasound and pathology
Time Frame: From clinical suspicion to final diagnosis (around 1 month)
Number of patients for whom Doppler ultrasound and biopsy analysis results are negative but who are considered to have GCA by the clinician
From clinical suspicion to final diagnosis (around 1 month)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Groupe Hospitalier de la Rochelle Ré Aunis

Investigators

  • Study Director: Christophe RONCATO, MD, Groupe Hospitalier de la Rochelle Ré Aunis

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 14, 2025

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

March 31, 2027

Study Registration Dates

First Submitted

December 13, 2024

First Submitted That Met QC Criteria

December 18, 2024

First Posted (Actual)

December 19, 2024

Study Record Updates

Last Update Posted (Actual)

June 20, 2025

Last Update Submitted That Met QC Criteria

June 17, 2025

Last Verified

June 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P02/043

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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