CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 165 enrolled
Drug / intervention
color Doppler ultrasound and TAB in case of CDU negativeother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02703922
NCT02703922N/ACompleted

Evaluation of a Diagnostic Strategy for Giant Cell Arteritis Based on Color Doppler Ultrasound of Temporal Arteries

Poitiers University Hospital·interventional·Posted Mar 9, 2016·Updated Dec 13, 2024

In Brief

A clinical study evaluating color Doppler ultrasound and TAB in case of CDU negative for Giant Cell Arteritis. Completed, enrolled 165 participants across 6 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesFrance

Timeline

N/ACompletedFinished
20162017201820192020202120222023202420252026
First PostedMar 9, 2016
Enrollment StartAug 29, 2016
Primary CompletionFeb 10, 2020
Study CompletionFeb 10, 2022
TodayJul 2, 2026
Enrollment to primary: 3.4 yearsPosted 10.3 years ago

Interventions

color Doppler ultrasound and TAB in case of CDU negativeother

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