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Validation of a Diagnostic Algorithm of Giant Cell Arteritis

NCT ID: NCT02703922

Last Updated: 2024-12-13

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

165 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-08-29

Study Completion Date

2022-02-10

Brief Summary

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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.

Detailed Description

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Conditions

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Giant Cell Arteritis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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GCA suspicion

A first screening is performed using color Doppler ultrasound. In case of negative results, patients undergo TAB.

Group Type OTHER

color Doppler ultrasound and TAB in case of CDU negative

Intervention Type OTHER

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

Interventions

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color Doppler ultrasound and TAB in case of CDU negative

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

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Groupe Hospitalier de la Rochelle Ré Aunis

OTHER

Sponsor Role collaborator

Centre Hospitalier de Rochefort

OTHER

Sponsor Role collaborator

Poitiers University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Christophe Roncato, MD

Role: STUDY_DIRECTOR

Groupe Hospitalier de la Rochelle Ré Aunis

Guillaume Denis, MD

Role: STUDY_DIRECTOR

Centre Hospitalier de Rochefort

Locations

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Centre Hospitalier d'Angoulême

Angoulême, , France

Site Status

Groupe Hospitalier de la Rochelle Ré Aunis

La Rochelle, , France

Site Status

Centre Hospitalier Universitaire de Nantes

Nantes, , France

Site Status

Centre Hospitalier de Niort

Niort, , France

Site Status

Centre Hospitalier Universitaire de Poitiers

Poitiers, , France

Site Status

Centre Hospitalier de Rochefort

Rochefort, , France

Site Status

Countries

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France

References

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Weyand CM, Goronzy JJ. Giant-cell arteritis and polymyalgia rheumatica. N Engl J Med. 2014 Oct 23;371(17):1653. doi: 10.1056/NEJMc1409206. No abstract available.

Reference Type BACKGROUND
PMID: 25337759 (View on PubMed)

Smith JH, Swanson JW. Giant cell arteritis. Headache. 2014 Sep;54(8):1273-89. doi: 10.1111/head.12425. Epub 2014 Jul 18.

Reference Type BACKGROUND
PMID: 25041449 (View on PubMed)

Petri H, Nevitt A, Sarsour K, Napalkov P, Collinson N. Incidence of giant cell arteritis and characteristics of patients: data-driven analysis of comorbidities. Arthritis Care Res (Hoboken). 2015 Mar;67(3):390-5. doi: 10.1002/acr.22429.

Reference Type BACKGROUND
PMID: 25132663 (View on PubMed)

Calvo-Romero JM. Giant cell arteritis. Postgrad Med J. 2003 Sep;79(935):511-5. doi: 10.1136/pmj.79.935.511.

Reference Type BACKGROUND
PMID: 13679546 (View on PubMed)

Roblot P. [When should Horton's disease be suspected?]. Rev Prat. 1999 Mar 15;49(6):593-7. French.

Reference Type BACKGROUND
PMID: 10218393 (View on PubMed)

Baslund B, Helleberg M, Faurschou M, Obel N. Mortality in patients with giant cell arteritis. Rheumatology (Oxford). 2015 Jan;54(1):139-43. doi: 10.1093/rheumatology/keu303. Epub 2014 Aug 13.

Reference Type BACKGROUND
PMID: 25122725 (View on PubMed)

Nuenninghoff DM, Hunder GG, Christianson TJ, McClelland RL, Matteson EL. Mortality of large-artery complication (aortic aneurysm, aortic dissection, and/or large-artery stenosis) in patients with giant cell arteritis: a population-based study over 50 years. Arthritis Rheum. 2003 Dec;48(12):3532-7. doi: 10.1002/art.11480.

Reference Type BACKGROUND
PMID: 14674005 (View on PubMed)

Kermani TA, Warrington KJ, Crowson CS, Ytterberg SR, Hunder GG, Gabriel SE, Matteson EL. Large-vessel involvement in giant cell arteritis: a population-based cohort study of the incidence-trends and prognosis. Ann Rheum Dis. 2013 Dec;72(12):1989-94. doi: 10.1136/annrheumdis-2012-202408. Epub 2012 Dec 19.

Reference Type BACKGROUND
PMID: 23253927 (View on PubMed)

Hunder GG, Bloch DA, Michel BA, Stevens MB, Arend WP, Calabrese LH, Edworthy SM, Fauci AS, Leavitt RY, Lie JT, et al. The American College of Rheumatology 1990 criteria for the classification of giant cell arteritis. Arthritis Rheum. 1990 Aug;33(8):1122-8. doi: 10.1002/art.1780330810.

Reference Type BACKGROUND
PMID: 2202311 (View on PubMed)

Hunder GG. The early history of giant cell arteritis and polymyalgia rheumatica: first descriptions to 1970. Mayo Clin Proc. 2006 Aug;81(8):1071-83. doi: 10.4065/81.8.1071.

Reference Type BACKGROUND
PMID: 16901030 (View on PubMed)

Roncato C, Allix-Beguec C, Bourgade R, Becker F, Goujon JM, Denis G, Espitia O. Temporal artery biopsy and temporal artery ultrasound inter-rater agreement for the diagnosis of giant cell arteritis: an ancillary analysis from the multicentre prospective ECHORTON study. Rheumatol Int. 2025 Oct 27;45(11):260. doi: 10.1007/s00296-025-06009-9.

Reference Type DERIVED
PMID: 41144031 (View on PubMed)

Denis G, Espitia O, Allix-Beguec C, Dieval C, Lorcerie F, Gombert B, Pouget-Abadie X, Toquet C, Agard C, Raimbeau A, Gautier G, Goujon JM, Durand G, Thollot-Karolewicz C, Lormeau C, Grados A, Grenot-Mercier A, El-Khoury R, Riche A, Hospital F, Visee S, Auriault ML, Landron C, Martin M, Roncato C. Diagnostic Strategy Using Color Doppler Ultrasound of Temporal Arteries in Patients With High Clinical Suspicion of Giant Cell Arteritis : A Prospective Cohort Study. Ann Intern Med. 2024 Jun;177(6):729-737. doi: 10.7326/M23-3417. Epub 2024 May 7.

Reference Type DERIVED
PMID: 38710093 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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ECHORTON

Identifier Type: -

Identifier Source: org_study_id