Validation of a Diagnostic Algorithm of Giant Cell Arteritis

Giant Cell Arteritis Clinical Trial

— ECHORTON  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02703922
• Other study ID #: ECHORTON
• Status: Completed
• Phase: N/A
• Start date: August 29, 2016
• Est. completion date: February 10, 2022

Study information

• Verified date: April 2022
• Source: Poitiers University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 information / eligibility

• Status: Completed
• Enrollment: 168
• Est. completion date: February 10, 2022
• Est. primary completion date: February 10, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

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.

Related Conditions & MeSH terms

• Arteritis
• Giant Cell Arteritis
• Polymyalgia Rheumatica

Intervention

Other:
• color Doppler ultrasound and TAB in case of CDU negative
Screening with color Doppler ultrasound followed by TAB in case of CDU negative

Locations

Country	Name	City	State
France	Centre Hospitalier d'Angoulême	Angoulême
France	Groupe Hospitalier de la Rochelle Ré Aunis	La Rochelle
France	Centre Hospitalier Universitaire de Nantes	Nantes
France	Centre Hospitalier de Niort	Niort
France	Centre Hospitalier Universitaire de Poitiers	Poitiers
France	Centre Hospitalier de Rochefort	Rochefort

Sponsors (3)

Lead Sponsor	Collaborator
Poitiers University Hospital	Centre Hospitalier de Rochefort, Groupe Hospitalier de la Rochelle Ré Aunis

Country where clinical trial is conducted

France, 

References & Publications (10)

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. — View Citation

Calvo-Romero JM. Giant cell arteritis. Postgrad Med J. 2003 Sep;79(935):511-5. Review. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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

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

Weyand CM, Goronzy JJ. Giant-cell arteritis and polymyalgia rheumatica. N Engl J Med. 2014 Oct 23;371(17):1653. doi: 10.1056/NEJMc1409206. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	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
Secondary	Number of correctly interpreted TAB	Reproducibility of TAB interpretation	1 month (after second blind reading of histological specimen and doppler imaging)
Secondary	Number of correctly interpreted CDU	Reproducibility of CDU interpretation	1 month (after second blind reading of histological specimen and doppler imaging)
Secondary	Cost-result of the algorithm	Diagnostic costs, induced costs, avoided costs	after 2 years of follow-up