- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04204512
Comparison of 22Mhz and 18Mhz High-frequency Probes for the Ultrasound Study of Temporal Arteries in Patients Suspected of Having Giant Cell Arteritis (ECHORTON)
August 23, 2021 updated by: University Hospital, Brest
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.
Study Overview
Status
Completed
Conditions
Detailed Description
Comparison of the results obtained by using 2 different frequencies probes in the diagnosis of giant cell arteritis
Study Type
Observational
Enrollment (Actual)
80
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Brest, France, 29609
- CHRU de Brest
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
50 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
patients with suspicion of giant cell arteritis
Description
Inclusion Criteria:
- sedimentation rate> 50 mm/h or recent unusual headache or unusual fever, recent visual trouble or jaw claudication, or induration temporal arteritis
Exclusion Criteria:
- previous diagnosis of giant cell arteritis and relapse of the giant cell arteritis and opposition to participate
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
halo sign of temporal arteritis
Time Frame: inclusion
|
hypoechogenicity of the wall artery
|
inclusion
|
compression sign of of temporal arteritis
Time Frame: inclusion
|
persistent of increased inflammatory arteries wall
|
inclusion
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
halo sign of carotid arteritis
Time Frame: inclusion
|
hypoechogenicity of the wall artery
|
inclusion
|
halo sign of subclavian arteritis
Time Frame: inclusion
|
hypoechogenicity of the wall artery
|
inclusion
|
halo sign of axillary arteritis
Time Frame: inclusion
|
hypoechogenicity of the wall artery
|
inclusion
|
other structural abnormalities in unilateral B mode
Time Frame: inclusion
|
stenosis, occlusion
|
inclusion
|
other structural abnormalities in bilateral B mode
Time Frame: inclusion
|
stenosis, occlusion
|
inclusion
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
December 17, 2019
Primary Completion (ACTUAL)
August 24, 2020
Study Completion (ACTUAL)
August 24, 2020
Study Registration Dates
First Submitted
December 17, 2019
First Submitted That Met QC Criteria
December 17, 2019
First Posted (ACTUAL)
December 19, 2019
Study Record Updates
Last Update Posted (ACTUAL)
August 24, 2021
Last Update Submitted That Met QC Criteria
August 23, 2021
Last Verified
July 1, 2021
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Cardiovascular Diseases
- Vascular Diseases
- Cerebrovascular Disorders
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Skin Diseases
- Immune System Diseases
- Autoimmune Diseases of the Nervous System
- Autoimmune Diseases
- Musculoskeletal Diseases
- Rheumatic Diseases
- Connective Tissue Diseases
- Muscular Diseases
- Vasculitis
- Skin Diseases, Vascular
- Vasculitis, Central Nervous System
- Polymyalgia Rheumatica
- Giant Cell Arteritis
- Arteritis
Other Study ID Numbers
- ECHORTON (29BRC19.0275)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
All collected data that underlie results in a publication
IPD Sharing Time Frame
Data will be available beginning 18 month and ending five years following the end of study
IPD Sharing Access Criteria
Data access requests will be reviewed by the internal committee of Brest UH.
Requestors will be required to sign and complete a data access agreement.
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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