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

Primary Purpose

Giant Cell Arteritis

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
color Doppler ultrasound and TAB in case of CDU negative
Sponsored by
Poitiers University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Giant Cell Arteritis

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Centre Hospitalier d'Angoulême
  • Groupe Hospitalier de la Rochelle Ré Aunis
  • Centre Hospitalier Universitaire de Nantes
  • Centre Hospitalier de Niort
  • Centre Hospitalier Universitaire de Poitiers
  • Centre Hospitalier de Rochefort

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

GCA suspicion

Arm Description

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

Outcomes

Primary Outcome Measures

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."

Secondary Outcome Measures

rate of "TAB positive" among "negative or doubtful CDU "
Number of TAB positive patients per patients with negative or doubtful CDU
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
Number of correctly interpreted TAB
Reproducibility of TAB interpretation
Number of correctly interpreted CDU
Reproducibility of CDU interpretation
Cost-result of the algorithm
Diagnostic costs, induced costs, avoided costs

Full Information

First Posted
March 3, 2016
Last Updated
April 19, 2022
Sponsor
Poitiers University Hospital
Collaborators
Groupe Hospitalier de la Rochelle Ré Aunis, Centre Hospitalier de Rochefort
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1. Study Identification

Unique Protocol Identification Number
NCT02703922
Brief Title
Validation of a Diagnostic Algorithm of Giant Cell Arteritis
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
August 29, 2016 (Actual)
Primary Completion Date
February 10, 2020 (Actual)
Study Completion Date
February 10, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Poitiers University Hospital
Collaborators
Groupe Hospitalier de la Rochelle Ré Aunis, Centre Hospitalier de Rochefort

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Giant Cell Arteritis

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
168 (Actual)

8. Arms, Groups, and Interventions

Arm Title
GCA suspicion
Arm Type
Other
Arm Description
A first screening is performed using color Doppler ultrasound. In case of negative results, patients undergo TAB.
Intervention Type
Other
Intervention Name(s)
color Doppler ultrasound and TAB in case of CDU negative
Intervention Description
Screening with color Doppler ultrasound followed by TAB in case of CDU negative
Primary Outcome Measure Information:
Title
Number of CDU false-positive patients
Description
patients with an alternative diagnosis within 2 years of follow-up among patients considered with GCA on a clinico-biological suspicion + Doppler "positive."
Time Frame
after 2 years of follow-up
Secondary Outcome Measure Information:
Title
rate of "TAB positive" among "negative or doubtful CDU "
Description
Number of TAB positive patients per patients with negative or doubtful CDU
Time Frame
within 1 month (during diagnostic algorithm)
Title
Number of patients with a persistent Halo at second CDU examination
Description
Describe S3/S4 Halo changes, and study correlation between persistence and poorer clinical response
Time Frame
after 2 years of follow-up
Title
Number of correctly interpreted TAB
Description
Reproducibility of TAB interpretation
Time Frame
1 month (after second blind reading of histological specimen and doppler imaging)
Title
Number of correctly interpreted CDU
Description
Reproducibility of CDU interpretation
Time Frame
1 month (after second blind reading of histological specimen and doppler imaging)
Title
Cost-result of the algorithm
Description
Diagnostic costs, induced costs, avoided costs
Time Frame
after 2 years of follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christophe Roncato, MD
Organizational Affiliation
Groupe Hospitalier de la Rochelle Ré Aunis
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Guillaume Denis, MD
Organizational Affiliation
Centre Hospitalier de Rochefort
Official's Role
Study Director
Facility Information:
Facility Name
Centre Hospitalier d'Angoulême
City
Angoulême
Country
France
Facility Name
Groupe Hospitalier de la Rochelle Ré Aunis
City
La Rochelle
ZIP/Postal Code
17019
Country
France
Facility Name
Centre Hospitalier Universitaire de Nantes
City
Nantes
Country
France
Facility Name
Centre Hospitalier de Niort
City
Niort
ZIP/Postal Code
79021
Country
France
Facility Name
Centre Hospitalier Universitaire de Poitiers
City
Poitiers
ZIP/Postal Code
86021
Country
France
Facility Name
Centre Hospitalier de Rochefort
City
Rochefort
ZIP/Postal Code
17301
Country
France

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
25337759
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. No abstract available.
Results Reference
background
PubMed Identifier
25041449
Citation
Smith JH, Swanson JW. Giant cell arteritis. Headache. 2014 Sep;54(8):1273-89. doi: 10.1111/head.12425. Epub 2014 Jul 18.
Results Reference
background
PubMed Identifier
25132663
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.
Results Reference
background
PubMed Identifier
13679546
Citation
Calvo-Romero JM. Giant cell arteritis. Postgrad Med J. 2003 Sep;79(935):511-5. doi: 10.1136/pmj.79.935.511.
Results Reference
background
PubMed Identifier
10218393
Citation
Roblot P. [When should Horton's disease be suspected?]. Rev Prat. 1999 Mar 15;49(6):593-7. French.
Results Reference
background
PubMed Identifier
25122725
Citation
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.
Results Reference
background
PubMed Identifier
14674005
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. doi: 10.1002/art.11480.
Results Reference
background
PubMed Identifier
23253927
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.
Results Reference
background
PubMed Identifier
2202311
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. doi: 10.1002/art.1780330810.
Results Reference
background
PubMed Identifier
16901030
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. doi: 10.4065/81.8.1071.
Results Reference
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Validation of a Diagnostic Algorithm of Giant Cell Arteritis

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