Clinical trial NCT02703922: Validation of a Diagnostic Algorithm of Giant Cell Arteritis
Official title: Evaluation of a Diagnostic Strategy for Giant Cell Arteritis Based on Color Doppler Ultrasound of Temporal Arteries
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Giant Cell Arteritis
Lead sponsor: Poitiers University Hospital
Sponsor class: OTHER
Collaborators: name: Groupe Hospitalier de la Rochelle Ré Aunis
name: Centre Hospitalier de Rochefort
First posted: 2016-03-09
Enrollment: 165
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief 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.


Eligibility criteria: Inclusion Criteria:

* ≥ 50 years
* C reactive protein (CRP) above normal
* Suspected of GCA according to clinician expertise and / or aortitis arteritis or of one or more arteries from the aorta imaging (CT angiography, magnetic resonance angiography or positron emission tomography TDM18FDG)
* Benefiting from Social Security or receiving it via a third party
* have given their participation agreement by understanding and accepting the constraints of the study

Exclusion Criteria:

* Received corticosteroid dose ≥ 20 mg of prednisone equivalent for more than 7 days in the month before inclusion
* Underwent temporal artery biopsy before color Doppler ultrasound
* History of GCA
* Terminal palliative phase or suffering from a disease or comorbidities such as life is involved in less than a year
* Patient with severe cognitive impairment
* Patient that can not be followed by the investigator for the duration of the study
* Refusal to participate in the study
* With enhanced protection (namely those deprived of liberty by a court or administrative order, patient staying in a health or social institution, under legal protection, and patients in emergencies)
* Pregnant or breastfeeding women, women of childbearing age who do not have effective contraception
* Participating in another clinical trial.

Primary outcomes:
measure: Number of CDU False-positive Patients
timeFrame: after 2 years of follow-up
Secondary outcomes:
measure: Rate of "Temporal Artery Biopsy Positive" Among "Negative or Doubtful CDU "
timeFrame: within 1 month (during diagnostic algorithm)
measure: Number of Patients With a Persistent Halo at Second CDU Examination
timeFrame: after 2 years of follow-up
measure: Number of Correctly Interpreted TAB
timeFrame: 1 month (after second blind reading of histological specimen and doppler imaging)
measure: Number of Correctly Interpreted CDU
timeFrame: 1 month (after second blind reading of histological specimen and doppler imaging)
Other outcomes:
Locations:
city: Angoulême
country: France
facility: Centre Hospitalier d'Angoulême
city: La Rochelle
country: France
facility: Groupe Hospitalier de la Rochelle Ré Aunis
city: Nantes
country: France
facility: Centre Hospitalier Universitaire de Nantes
city: Niort
country: France
facility: Centre Hospitalier de Niort
city: Poitiers
country: France
facility: Centre Hospitalier Universitaire de Poitiers
city: Rochefort
country: France
facility: Centre Hospitalier de Rochefort
Study officials:
affiliation: Groupe Hospitalier de la Rochelle Ré Aunis
name: Christophe Roncato, MD
role: STUDY_DIRECTOR
affiliation: Centre Hospitalier de Rochefort
name: Guillaume Denis, MD
role: STUDY_DIRECTOR
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