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

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ClinicalTrials.gov Identifier: NCT02703922
Recruitment Status : Recruiting
First Posted : March 9, 2016
Last Update Posted : August 30, 2017
Sponsor:
Collaborators:
Groupe Hospitalier de la Rochelle Ré Aunis
Centre Hospitalier de Rochefort
Information provided by (Responsible Party):
Poitiers University Hospital

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.

Condition or disease Intervention/treatment Phase
Giant Cell Arteritis Other: color Doppler ultrasound and TAB in case of CDU negative Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 168 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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
Actual Study Start Date : August 29, 2016
Estimated Primary Completion Date : August 28, 2018
Estimated Study Completion Date : September 28, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. Number of CDU false-positive patients [ Time Frame: after 2 years of follow-up ]
    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 :
  1. rate of "TAB positive" among "negative or doubtful CDU " [ Time Frame: within 1 month (during diagnostic algorithm) ]
    Number of TAB positive patients per patients with negative or doubtful CDU

  2. Number of patients with a persistent Halo at second CDU examination [ Time Frame: after 2 years of follow-up ]
    Describe S3/S4 Halo changes, and study correlation between persistence and poorer clinical response

  3. Number of correctly interpreted TAB [ Time Frame: 1 month (after second blind reading of histological specimen and doppler imaging) ]
    Reproducibility of TAB interpretation

  4. Number of correctly interpreted CDU [ Time Frame: 1 month (after second blind reading of histological specimen and doppler imaging) ]
    Reproducibility of CDU interpretation

  5. Cost-result of the algorithm [ Time Frame: after 2 years of follow-up ]
    Diagnostic costs, induced costs, avoided costs



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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02703922


Contacts
Contact: Caroline Allix-Béguec, Ph.D. +33516494246 caroline.allix-beguec@ch-larochelle.fr

Locations
France
Centre Hospitalier d'Angoulême Recruiting
Angoulême, France
Contact: Agnes RICHE, MD         
Groupe Hospitalier de la Rochelle Ré Aunis Recruiting
La Rochelle, France, 17019
Contact: Karen Renaud    +33516494245    karen.renaud-geffard@ch-larochelle.fr   
Principal Investigator: Mariam Saberan-Roncato, MD         
Principal Investigator: Bruno Gombert, MD         
Principal Investigator: Gaëlle Godenèche, MD         
Principal Investigator: Bruno Grossin, MD         
Sub-Investigator: Elisabeth Brottier, MD         
Sub-Investigator: Lydia Faba, MD         
Sub-Investigator: Xavier Pouget-Abadie, MD         
Sub-Investigator: Claire Martin, MD         
Centre Hospitalier de Niort Recruiting
Niort, France, 79021
Contact: Marjorie Dezaux       marjorie.dezaux@ch-niort.fr   
Principal Investigator: Claire Blanchard-Delaunay, MD         
Principal Investigator: Christian Lormeau, MD         
Centre Hospitalier Universitaire de Poitiers Recruiting
Poitiers, France, 86021
Contact: Fanny Abriat    +33549443796    fanny.abriat@chu-poitiers.fr   
Principal Investigator: Cédric Landron, MD         
Principal Investigator: Elisabeth Solau, MD         
Sub-Investigator: Géraldine Durand, MD         
Centre Hospitalier de Rochefort Recruiting
Rochefort, France, 17301
Contact: Guillaume Denis, MD    +33546885600    guillaume.denis@ch-rochefort.fr   
Principal Investigator: Guillaume Denis, MD         
Sub-Investigator: Céline Dieval, MD         
Sponsors and Collaborators
Poitiers University Hospital
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:

Responsible Party: Poitiers University Hospital
ClinicalTrials.gov Identifier: NCT02703922     History of Changes
Other Study ID Numbers: ECHORTON
First Posted: March 9, 2016    Key Record Dates
Last Update Posted: August 30, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
Giant Cell Arteritis
Polymyalgia Rheumatica
Arteritis
Vasculitis
Vascular Diseases
Cardiovascular Diseases
Vasculitis, Central Nervous System
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Skin Diseases, Vascular
Skin Diseases
Autoimmune Diseases
Immune System Diseases
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases