Validation of a Diagnostic Algorithm of Giant Cell Arteritis (ECHORTON)

Validation d'un Algorithme Diagnostique de l'artérite Temporale Giganto-cellulaire basé Sur l'échographie-doppler Couleur Des artères Temporales Superficielles et Des Axes Cervico-encéphaliques

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 Overview

• Status: Completed
• Conditions: Giant Cell Arteritis
• Intervention / Treatment: Other: color Doppler ultrasound and TAB in case of CDU negative

• Study Type: Interventional
• Enrollment (Actual): 168
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Angoulême, France
    • Centre Hospitalier d'Angoulème
  • La Rochelle, France, 17019
    • Groupe Hospitalier de la Rochelle Ré Aunis
  • Nantes, France
    • Centre Hospitalier Universitaire de Nantes
  • Niort, France, 79021
    • Centre Hospitalier de Niort
  • Poitiers, France, 86021
    • Centre Hospitalier Universitaire de Poitiers
  • Rochefort, France, 17301
    • Centre Hospitalier de Rochefort

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 48 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: GCA suspicion; 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; Screening with color Doppler ultrasound followed by TAB in case of CDU negative

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of CDU false-positive patients	patients with an alternative diagnosis within 2 years of follow-up among patients considered with GCA on a clinico-biological suspicion + Doppler "positive."	after 2 years of follow-up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
rate of "TAB positive" among "negative or doubtful CDU "	Number of TAB positive patients per patients with negative or doubtful CDU	within 1 month (during diagnostic algorithm)
Number of patients with a persistent Halo at second CDU examination	Describe S3/S4 Halo changes, and study correlation between persistence and poorer clinical response	after 2 years of follow-up
Number of correctly interpreted TAB	Reproducibility of TAB interpretation	1 month (after second blind reading of histological specimen and doppler imaging)
Number of correctly interpreted CDU	Reproducibility of CDU interpretation	1 month (after second blind reading of histological specimen and doppler imaging)
Cost-result of the algorithm	Diagnostic costs, induced costs, avoided costs	after 2 years of follow-up

Collaborators and Investigators

• Sponsor: Poitiers University Hospital
• Collaborators: Groupe Hospitalier de la Rochelle Ré Aunis; Centre Hospitalier de Rochefort
• Investigators: Study Director: Christophe Roncato, MD, Groupe Hospitalier de la Rochelle Ré Aunis; Study Director: Guillaume Denis, MD, Centre Hospitalier de Rochefort

Publications and helpful links

General Publications

• 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.
• 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.
• Smith JH, Swanson JW. Giant cell arteritis. Headache. 2014 Sep;54(8):1273-89. doi: 10.1111/head.12425. Epub 2014 Jul 18.
• 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.
• Calvo-Romero JM. Giant cell arteritis. Postgrad Med J. 2003 Sep;79(935):511-5. doi: 10.1136/pmj.79.935.511.
• Roblot P. [When should Horton's disease be suspected?]. Rev Prat. 1999 Mar 15;49(6):593-7. French.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): August 29, 2016
• Primary Completion (Actual): February 10, 2020
• Study Completion (Actual): February 10, 2022

Study Registration Dates

• First Submitted: March 3, 2016
• First Submitted That Met QC Criteria: March 3, 2016
• First Posted (Estimate): March 9, 2016

Study Record Updates

• Last Update Posted (Actual): April 20, 2022
• Last Update Submitted That Met QC Criteria: April 19, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Skin Diseases; Immune System Diseases; Autoimmune Diseases of the Nervous System; Autoimmune Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Muscular Diseases; Vasculitis; Skin Diseases, Vascular; Vasculitis, Central Nervous System; Polymyalgia Rheumatica; Giant Cell Arteritis; Arteritis
• Other Study ID Numbers: ECHORTON

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided