N/A
N=165
Validation of a Diagnostic Algorithm of Giant Cell Arteritis
Giant Cell Arteritis
Bottom Line
View on ClinicalTrials.gov: NCT02703922 ↗Enrolled (actual)
165
Serious AEs
18.2%
Results posted
Dec 2024
Primary outcome: Primary: Number of CDU False-positive Patients — 73; 63; 0; 29 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- color Doppler ultrasound and TAB in case of CDU negative (Other)
- Age
- Adult, Older Adult · 50+ yrs
- Sex
- All
- Sponsor
- Poitiers University Hospital
- Primary completion
- Feb 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of CDU False-positive Patients |
73; 63; 0; 29 | — |
| SECONDARY Rate of "Temporal Artery Biopsy Positive" Among "Negative or Doubtful CDU " |
28; 57; 7 | — |
| SECONDARY Number of Patients With a Persistent Halo at Second CDU Examination |
9; 30; 25; 9 | — |
| SECONDARY Number of Correctly Interpreted TAB |
58; 28; 6; 0; 55; 18 | — |
| SECONDARY Number of Correctly Interpreted CDU |
73; 0; 0; 92; 0; 0 | — |
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.
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.
Data sourced from ClinicalTrials.gov (NCT02703922). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.