Giant Cell ArteritisECHORTONNCT02703922
Validation of a Diagnostic Algorithm of Giant Cell Arteritis
A study testing color Doppler ultrasound and TAB in case of CDU negative in people with Giant Cell Arteritis, run by Poitiers University Hospital at 6 sites in France.
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. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Giant Cell Arteritis
- What is being tested?
- color Doppler ultrasound and TAB in case of CDU negative
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 165 participants
- Where
- 6 sitesFrance
- Study dates
- 29 Aug 2016to 10 Feb 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥ 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
Who cannot join
- 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
Show all 10Show fewer
- 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.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
France6 sites
Centre Hospitalier d'Angoulême
Angoulême
Groupe Hospitalier de la Rochelle Ré Aunis
La Rochelle, 17019
Centre Hospitalier Universitaire de Nantes
Nantes
Centre Hospitalier de Niort
Niort, 79021
Centre Hospitalier Universitaire de Poitiers
Poitiers, 86021
Centre Hospitalier de Rochefort
Rochefort, 17301
About this study
Official title: Evaluation of a Diagnostic Strategy for Giant Cell Arteritis Based on Color Doppler Ultrasound of Temporal Arteries
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.
- Conditions
- Giant Cell Arteritis
- Being tested
- color Doppler ultrasound and TAB in case of CDU negative
- Medical subject headings
- Giant Cell Arteritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
color Doppler ultrasound and TAB in case of CDU negativeOther
Screening with color Doppler ultrasound followed by TAB in case of CDU negative
| Study group | Role | What they receive |
|---|---|---|
| GCA suspicion | Other | A first screening is performed using color Doppler ultrasound. In case of negative results, patients undergo TAB. Receives: Other: color Doppler ultrasound and TAB in case of CDU negative |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of CDU False-positive Patients
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."
Measured: after 2 years of follow-up
Secondary outcomes (4)
Rate of "Temporal Artery Biopsy Positive" Among "Negative or Doubtful CDU "
Number of temporal artery biopsy (TAB) positive patients among patients with negative or doubtful CDU
Measured: within 1 month (during diagnostic algorithm)
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
Measured: after 2 years of follow-up
Number of Correctly Interpreted TAB
Reproducibility of TAB interpretation
Measured: 1 month (after second blind reading of histological specimen and doppler imaging)
Number of Correctly Interpreted CDU
Reproducibility of CDU interpretation
Measured: 1 month (after second blind reading of histological specimen and doppler imaging)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2016 (estimated)
- Study start29 Aug 2016
- Primary completion10 Feb 2020
- Study completion10 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Giant Cell ArteritisStudies of the same condition, open and under way.
- More trials run by Poitiers University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 165 participants (actual)
Sponsor and investigators
- Lead sponsor
- Poitiers University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Groupe Hospitalier de la Rochelle Ré Aunis, Centre Hospitalier de Rochefort
- Responsible party
- Sponsor
- Investigators
- Christophe Roncato, MD, Study director, Groupe Hospitalier de la Rochelle Ré AunisGuillaume Denis, MD, Study director, Centre Hospitalier de Rochefort
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02703922
- Sponsor's protocol ID
- ECHORTON
- Acronym
- ECHORTON
- Status last verified
- Nov 2024
- First submitted
- 3 Mar 2016
- Last updated
- 13 Dec 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 25337759Smith JH, Swanson JW. Giant cell arteritis. Headache. 2014 Sep;54(8):1273-89. doi: 10.1111/head.12425. Epub 2014 Jul 18.
PubMed 25041449Petri 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.
PubMed 25132663Calvo-Romero JM. Giant cell arteritis. Postgrad Med J. 2003 Sep;79(935):511-5. doi: 10.1136/pmj.79.935.511.
PubMed 13679546Roblot P. [When should Horton's disease be suspected?]. Rev Prat. 1999 Mar 15;49(6):593-7. French.
PubMed 10218393Baslund 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.
PubMed 25122725Nuenninghoff 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.
PubMed 14674005Kermani 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.
PubMed 23253927Hunder 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.
PubMed 2202311Hunder 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.
PubMed 16901030Roncato C, Allix-Beguec C, Bourgade R, Becker F, Goujon JM, Denis G, Espitia O. Temporal artery biopsy and temporal artery ultrasound inter-rater agreement for the diagnosis of giant cell arteritis: an ancillary analysis from the multicentre prospective ECHORTON study. Rheumatol Int. 2025 Oct 27;45(11):260. doi: 10.1007/s00296-025-06009-9.
PubMed 41144031Denis G, Espitia O, Allix-Beguec C, Dieval C, Lorcerie F, Gombert B, Pouget-Abadie X, Toquet C, Agard C, Raimbeau A, Gautier G, Goujon JM, Durand G, Thollot-Karolewicz C, Lormeau C, Grados A, Grenot-Mercier A, El-Khoury R, Riche A, Hospital F, Visee S, Auriault ML, Landron C, Martin M, Roncato C. Diagnostic Strategy Using Color Doppler Ultrasound of Temporal Arteries in Patients With High Clinical Suspicion of Giant Cell Arteritis : A Prospective Cohort Study. Ann Intern Med. 2024 Jun;177(6):729-737. doi: 10.7326/M23-3417. Epub 2024 May 7.
PubMed 38710093
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Diagnostic Strategy for Giant Cell Arteritis Based on Color Doppler Ultrasound of Temporal Arteries
- ClinicalTrials.gov ID
- NCT02703922
- Acronym / sponsor ID
- ECHORTON / ECHORTON
- Conditions
- Giant Cell Arteritis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 165 participants (actual)
- Lead sponsor
- Poitiers University HospitalUniversity, hospital or other
- Collaborators
- Groupe Hospitalier de la Rochelle Ré Aunis, Centre Hospitalier de Rochefort
- Study start
- 29 Aug 2016 (actual)
- Primary completion
- 10 Feb 2020 (actual)
- Study completion
- 10 Feb 2022 (actual)
- First posted
- 9 Mar 2016 (estimated)
- Results
- Posted 13 Dec 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| GCA suspicion | Other | Other: color Doppler ultrasound and TAB in case of CDU negativeA first screening is performed using color Doppler ultrasound. In case of negative results, patients undergo TAB. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- ≥ 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| color Doppler ultrasound and TAB in case of CDU negativeScreening with color Doppler ultrasound followed by TAB in case of CDU negative | Other | GCA suspicion |
Primary outcome
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."
4 secondary outcomes
Rate of "Temporal Artery Biopsy Positive" Among "Negative or Doubtful CDU "
Time frame: within 1 month (during diagnostic algorithm)
Number of Patients With a Persistent Halo at Second CDU Examination
Time frame: after 2 years of follow-up
Number of Correctly Interpreted TAB
Time frame: 1 month (after second blind reading of histological specimen and doppler imaging)
Number of Correctly Interpreted CDU
Time frame: 1 month (after second blind reading of histological specimen and doppler imaging)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 25337759Weyand 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.
- Background: PubMed 25041449Smith JH, Swanson JW. Giant cell arteritis. Headache. 2014 Sep;54(8):1273-89. doi: 10.1111/head.12425. Epub 2014 Jul 18.
- Background: PubMed 25132663Petri 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.
- Background: PubMed 13679546Calvo-Romero JM. Giant cell arteritis. Postgrad Med J. 2003 Sep;79(935):511-5. doi: 10.1136/pmj.79.935.511.
- Background: PubMed 10218393Roblot P. [When should Horton's disease be suspected?]. Rev Prat. 1999 Mar 15;49(6):593-7. French.
- Background: PubMed 25122725Baslund 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.
- Background: PubMed 14674005Nuenninghoff 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.
- Background: PubMed 23253927Kermani 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.
- Background: PubMed 2202311Hunder 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.
- Background: PubMed 16901030Hunder 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.
- Derived from this study: PubMed 41144031Roncato C, Allix-Beguec C, Bourgade R, Becker F, Goujon JM, Denis G, Espitia O. Temporal artery biopsy and temporal artery ultrasound inter-rater agreement for the diagnosis of giant cell arteritis: an ancillary analysis from the multicentre prospective ECHORTON study. Rheumatol Int. 2025 Oct 27;45(11):260. doi: 10.1007/s00296-025-06009-9.
- Derived from this study: PubMed 38710093Denis G, Espitia O, Allix-Beguec C, Dieval C, Lorcerie F, Gombert B, Pouget-Abadie X, Toquet C, Agard C, Raimbeau A, Gautier G, Goujon JM, Durand G, Thollot-Karolewicz C, Lormeau C, Grados A, Grenot-Mercier A, El-Khoury R, Riche A, Hospital F, Visee S, Auriault ML, Landron C, Martin M, Roncato C. Diagnostic Strategy Using Color Doppler Ultrasound of Temporal Arteries in Patients With High Clinical Suspicion of Giant Cell Arteritis : A Prospective Cohort Study. Ann Intern Med. 2024 Jun;177(6):729-737. doi: 10.7326/M23-3417. Epub 2024 May 7.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christophe Roncato, MD study director
Groupe Hospitalier de la Rochelle Ré Aunis
Guillaume Denis, MD study director
Centre Hospitalier de Rochefort
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing color Doppler ultrasound and TAB in case of CDU negative in people with Giant Cell Arteritis, run by Poitiers University Hospital at 6 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Dec 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of CDU False-positive Patients (time frame: after 2 years of follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02703922, which also lists 12 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Dec 2024.