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Validation of a Diagnostic Algorithm of Giant Cell Arteritis

NCT02703922 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 165

Last updated 2024-12-13

Study results available
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Summary

Giant cell arteritis (GCA or temporal arteritis or cranial arteritis) or Horton disease is a vasculitis that occurs in older adults, affecting vessels of medium and large caliber. The diagnosis of GCA is a challenge for general practitioners and specialists. Since 1970, it is based on a combination of clinical, biological and histological signs. Temporal artery biopsy (TAB) was the reference method until recently. However, TAB has many drawbacks. Therefore, researches of the past 20 years have been intended to develop alternative diagnostic methods. This was notably the case of the color Doppler ultrasound (CDU) since the description by Wolfgang Schmidt of the halo sign. Although European and British recommendations put CDU as second line method, many authors suggest the possibility to do without TAB in many cases. In addition, many practitioners believe that it is not "ethical" to use an invasive unprofitable procedure like TAB, and have already been using CDU in their routine practice. However, no diagnostic algorithm validating this approach in a prospective series has been published to date. Therefore, the present study aim at validating a diagnostic algorithm of giant cell arteritis using color Doppler imaging of temporal arteries and cervicocephalic axes as first screening method.

Conditions

  • Giant Cell Arteritis

Interventions

OTHER

color Doppler ultrasound and TAB in case of CDU negative

Screening with color Doppler ultrasound followed by TAB in case of CDU negative

Sponsors & Collaborators

  • Groupe Hospitalier de la Rochelle Ré Aunis

    collaborator OTHER

  • Centre Hospitalier de Rochefort

    collaborator OTHER

  • Poitiers University Hospital

    lead OTHER

Principal Investigators

  • Christophe Roncato, MD · Groupe Hospitalier de la Rochelle Ré Aunis

  • Guillaume Denis, MD · Centre Hospitalier de Rochefort

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-08-29
Primary Completion
2020-02-10
Completion
2022-02-10

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02703922 on ClinicalTrials.gov