Validation of a Diagnostic Algorithm of Giant Cell Arteritis

Not Applicable

Completed

Interventions: Other: color Doppler ultrasound and TAB in case of CDU negative

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.

Recruitment & Eligibility

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.

Arm && Interventions

Group	Intervention	Description
GCA suspicion	color Doppler ultrasound and TAB in case of CDU negative	A first screening is performed using color Doppler ultrasound. In case of negative results, patients undergo TAB.

Primary Outcome Measures

Name	Time	Method
Number of CDU False-positive Patients	after 2 years of follow-up	patients with an alternative diagnosis within 2 years of follow-up among patients considered with giant cell arteritis (GCA) on a clinico-biological suspicion + Doppler "positive."

Secondary Outcome Measures

Name	Time	Method
Number of Correctly Interpreted TAB	1 month (after second blind reading of histological specimen and doppler imaging)	Reproducibility of TAB interpretation
Rate of "Temporal Artery Biopsy Positive" Among "Negative or Doubtful CDU "	within 1 month (during diagnostic algorithm)	Number of temporal artery biopsy (TAB) positive patients among patients with negative or doubtful CDU
Number of Correctly Interpreted CDU	1 month (after second blind reading of histological specimen and doppler imaging)	Reproducibility of CDU interpretation
Number of Patients With a Persistent Halo at Second CDU Examination	after 2 years of follow-up	Describe S3/S4 Halo changes, and study correlation between persistence and poorer clinical response

Locations (6): Centre Hospitalier d'Angoulême
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Angoulême, France
Centre Hospitalier Universitaire de Nantes
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Nantes, France
Groupe Hospitalier de la Rochelle Ré Aunis
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La Rochelle, France
Centre Hospitalier de Niort
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Niort, France
Centre Hospitalier Universitaire de Poitiers
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Poitiers, France
Centre Hospitalier de Rochefort
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Rochefort, France