Validation of a Diagnostic Algorithm of Giant Cell Arteritis

NCT02703922 | Completed Results

• 1 other identifier: ECHORTON
• Study Type: interventional
• Target: 165
• Locations: 1 country
• Sites: 6

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.

Conditions

Giant Cell Arteritis

Outcome Measures

Primary Outcomes (1)

• Number of CDU False-positive Patients

  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."

  after 2 years of follow-up

Secondary Outcomes (4)

• Rate of "Temporal Artery Biopsy Positive" Among "Negative or Doubtful CDU "

  within 1 month (during diagnostic algorithm)

• Number of Patients With a Persistent Halo at Second CDU Examination

  after 2 years of follow-up

• Number of Correctly Interpreted TAB

  1 month (after second blind reading of histological specimen and doppler imaging)

• Number of Correctly Interpreted CDU

  1 month (after second blind reading of histological specimen and doppler imaging)

Study Arms (1)

GCA suspicion

OTHER

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

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

Interventions

color Doppler ultrasound and TAB in case of CDU negative OTHER

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

GCA suspicion

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥ 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Poitiers University Hospital: lead
• Groupe Hospitalier de la Rochelle Ré Aunis: collaborator
• Centre Hospitalier de Rochefort: collaborator

Study Sites (6)

Centre Hospitalier d'Angoulême

Angoulême, France

Location

Groupe Hospitalier de la Rochelle Ré Aunis

La Rochelle, 17019, France

Location

Centre Hospitalier Universitaire de Nantes

Nantes, France

Location

Centre Hospitalier de Niort

Niort, 79021, France

Location

Centre Hospitalier Universitaire de Poitiers

Poitiers, 86021, France

Location

Centre Hospitalier de Rochefort

Rochefort, 17301, France

Location

Related Publications (12)

• 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.

  PMID: 25337759 BACKGROUND

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

  PMID: 25041449 BACKGROUND

• 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.

  PMID: 25132663 BACKGROUND

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

  PMID: 13679546 BACKGROUND

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

  PMID: 10218393 BACKGROUND

• 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.

  PMID: 25122725 BACKGROUND

• 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.

  PMID: 14674005 BACKGROUND

• 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.

  PMID: 23253927 BACKGROUND

• 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.

  PMID: 2202311 BACKGROUND

• 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.

  PMID: 16901030 BACKGROUND

• 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.

  PMID: 41144031 DERIVED

• 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.

  PMID: 38710093 DERIVED

MeSH Terms

Conditions

Giant Cell Arteritis

Interventions

Tablets

Condition Hierarchy (Ancestors)

Vasculitis, Central Nervous System; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Arteritis; Vasculitis; Skin Diseases, Vascular; Skin Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Dosage Forms; Pharmaceutical Preparations

Results Point of Contact

• Title: Caroline Allix-Béguec, clinical research manager
• Organization: Groupe Hospitalier de la Rochelle Ré Aunis

caroline.allix-beguec@ght-atlantique17.fr

+33516494246

Study Officials

• Christophe Roncato, MD

  Groupe Hospitalier de la Rochelle Ré Aunis

  STUDY DIRECTOR

• Guillaume Denis, MD

  Centre Hospitalier de Rochefort

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 3, 2016
• First Posted: March 9, 2016
• Study Start: August 29, 2016
• Primary Completion: February 10, 2020
• Study Completion: February 10, 2022
• Last Updated: December 13, 2024
• Results First Posted: December 13, 2024

Record last verified: 2024-11

Locations

FR (6)