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NCT Number: NCT02703922

Validation of a Diagnostic Algorithm of Giant Cell Arteritis

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.

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Key information

Conditions

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

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre Hospitalier d'Angoulême, Angoulême, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

color Doppler ultrasound and TAB in case of CDU negative

Other

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

Primary outcomes

  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 giant cell arteritis (GCA) on a clinico-biological suspicion + Doppler "positive."

Secondary outcomes

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

    Time frame: within 1 month (during diagnostic algorithm)

    Number of temporal artery biopsy (TAB) positive patients among 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

Sponsors and collaborators

Lead sponsor

Poitiers University Hospital

Other

Collaborators

  • Centre Hospitalier de Rochefort
  • Groupe Hospitalier de la Rochelle Ré Aunis

Registry information

Official study title

Evaluation of a Diagnostic Strategy for Giant Cell Arteritis Based on Color Doppler Ultrasound of Temporal Arteries

Acronym: ECHORTON

Important dates

Study start
2016
Primary completion
2020
Study completion
2022
First posted
Mar 9, 2016
Registry last updated
Dec 13, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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