Giant Cell ArteritisECHORTONNCT04204512
Comparison of 22Mhz and 18Mhz High-frequency Probes for the Ultrasound Study of Temporal Arteries in Patients Suspected of Having Giant Cell Arteritis
An observational study of Giant Cell Arteritis, run by University Hospital, Brest at 1 site in France.
Trial summary
Evaluation of the structural features of temporal arteritis using two frequencies probes: 18 and 22Mhz. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Giant Cell Arteritis
- How many people
- 80 participants
- Where
- 1 siteFrance
- Study dates
- 17 Dec 2019to 24 Aug 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
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
Study population: patients with suspicion of giant cell arteritis
Who may be able to join
- sedimentation rate> 50 mm/h or recent unusual headache or unusual fever, recent visual trouble or jaw claudication, or induration temporal arteritis
Who cannot join
- previous diagnosis of giant cell arteritis and relapse of the giant cell arteritis and opposition to participate
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of 2 Probes Frequencies in the Diagnosis of Giant Cell Arteritis
Evaluation of the structural features of temporal arteritis using two frequencies probes: 18 and 22Mhz.
Read the detailed description
Comparison of the results obtained by using 2 different frequencies probes in the diagnosis of giant cell arteritis
- Conditions
- Giant Cell Arteritis
- Keywords
- ultrasound,, giant cell arteritis
- Medical subject headings
- Giant Cell Arteritis
What is being measured
The primary outcome is the main question the study is designed to answer.
halo sign of temporal arteritis
hypoechogenicity of the wall artery
Measured: inclusion
compression sign of of temporal arteritis
persistent of increased inflammatory arteries wall
Measured: inclusion
Secondary outcomes (5)
halo sign of carotid arteritis
hypoechogenicity of the wall artery
Measured: inclusion
halo sign of subclavian arteritis
hypoechogenicity of the wall artery
Measured: inclusion
halo sign of axillary arteritis
hypoechogenicity of the wall artery
Measured: inclusion
other structural abnormalities in unilateral B mode
stenosis, occlusion
Measured: inclusion
other structural abnormalities in bilateral B mode
stenosis, occlusion
Measured: inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2019
- Study start17 Dec 2019
- Primary completion24 Aug 2020
- Study completion24 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Giant Cell ArteritisStudies of the same condition, open and under way.
- More trials run by University Hospital, BrestThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Brest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04204512
- Sponsor's protocol ID
- ECHORTON (29BRC19.0275)
- Acronym
- ECHORTON
- Status last verified
- Jul 2021
- First submitted
- 17 Dec 2019
- Last updated
- 24 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All collected data that underlie results in a publication
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of 2 Probes Frequencies in the Diagnosis of Giant Cell Arteritis
- ClinicalTrials.gov ID
- NCT04204512
- Acronym / sponsor ID
- ECHORTON / ECHORTON (29BRC19.0275)
- Conditions
- Giant Cell Arteritis
- Keywords
- ultrasound,, giant cell arteritis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- University Hospital, BrestUniversity, hospital or other
- Study start
- 17 Dec 2019 (actual)
- Primary completion
- 24 Aug 2020 (actual)
- Study completion
- 24 Aug 2020 (actual)
- First posted
- 19 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Evaluation of the structural features of temporal arteritis using two frequencies probes: 18 and 22Mhz.
Detailed description
Comparison of the results obtained by using 2 different frequencies probes in the diagnosis of giant cell arteritis
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with suspicion of giant cell arteritis
Key inclusion criteria (1 listed)
- sedimentation rate> 50 mm/h or recent unusual headache or unusual fever, recent visual trouble or jaw claudication, or induration temporal arteritis
Key exclusion criteria (1 listed)
- previous diagnosis of giant cell arteritis and relapse of the giant cell arteritis and opposition to participate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
halo sign of temporal arteritis
Time frame: inclusion
hypoechogenicity of the wall artery
compression sign of of temporal arteritis
Time frame: inclusion
persistent of increased inflammatory arteries wall
5 secondary outcomes
halo sign of carotid arteritis
Time frame: inclusion
halo sign of subclavian arteritis
Time frame: inclusion
halo sign of axillary arteritis
Time frame: inclusion
other structural abnormalities in unilateral B mode
Time frame: inclusion
other structural abnormalities in bilateral B mode
Time frame: inclusion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2021.
- Individual participant dataSharing planned: Yes. All collected data that underlie results in a publication
Related trials for Giant Cell Arteritis
Recruiting
Using Personalized Rehabilitation to Reduce Disease and Increase Activity of Patients With Polymyalgia Rheumatica
Polymyalgia Rheumatica (PMR)
Not yet recruitingPhase 3
Aspirin for the Prevention of Ischemic Complications in Giant Cell Arteritis
Giant Cell Arteritis (GCA), Acute Coronary Syndrome (ACS)
RecruitingObservational study
Studies of the Natural History, Pathogenesis, and Outcome of Idiopathic Systemic Vasculitis
Takayasu's Arteritis, Giant Cell Arteritis
Active, not recruitingObservational study
The Applanation Tonometry in GCA Pilot
Giant Cell Arteritis
RecruitingObservational study
Early Temporal Dynamics of Optic Nerve Sheath Diameter After Therapy in GCA
Giant Cell Arteritis, Temporal Arteritis
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Giant Cell Arteritis, run by University Hospital, Brest at 1 site 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 1 inclusion and 1 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 24 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
halo sign of temporal arteritis (time frame: inclusion). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Aug 2021.