Horton DiseaseVELHORNCT03360162
Velocimetric Study of Temporal Arteries in Patients With Horton Disease Using Scan-Doppler
An observational study of Horton Disease, run by University Hospital, Brest at 1 site in France.
Trial summary
The use of ultrasonography in detecting giant cell arteritis ( GCA) is emerging. Currently, temporal biopsy is the gold standard to diagnose GCA but studies have shown the interest to use B mode ultrasonography. However, until now, the study of velocities in GCA have not been yet performed. Read more about this study
- Who is it for?
- Ages 55 years and older
- Conditions the study is for
- Horton Disease
- How many people
- 46 participants
- Where
- 1 siteFrance
- Study dates
- 2 Nov 2017to 10 Dec 2017
- 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 55 years and older
- All sexes
- Adult, Older adult
Study population: all patients aged more than 55 years old who are suspected of giant arteritis
Who may be able to join
- patients with suspicious giant arteritis
Who cannot join
- patients who have already been treated or diagnosed for giant arteritis
Trial locations and contacts
1 site in 1 country.
About this study
The use of ultrasonography in detecting giant cell arteritis ( GCA) is emerging. Currently, temporal biopsy is the gold standard to diagnose GCA but studies have shown the interest to use B mode ultrasonography. However, until now, the study of velocities in GCA have not been yet performed.
- Conditions
- Horton Disease
- Medical subject headings
- Giant Cell Arteritis
What is being measured
The primary outcome is the main question the study is designed to answer.
Velocimetric Study of Temporal Arteries in Patients With Horton Disease Using Scan-Doppler
velocimetric temporal arterial study in giant arteritis
Measured: 2 months
Secondary outcomes (1)
evaluation of the halo sign in giant arteritis using B mode ultrasonography
presence or absence of the halo sign in giant arteritis patients
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2017
- Study start2 Nov 2017
- Primary completion10 Dec 2017
- Study completion10 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Horton DiseaseStudies 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
- Retrospective
- Enrolment
- 46 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
- NCT03360162
- Sponsor's protocol ID
- VELHOR ( 29BRC17.0227)
- Acronym
- VELHOR
- Status last verified
- Apr 2020
- First submitted
- 28 Nov 2017
- Last updated
- 21 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Velocimetric Study of Temporal Arteries in Patients With Horton Disease Using Scan-Doppler
- ClinicalTrials.gov ID
- NCT03360162
- Acronym / sponsor ID
- VELHOR / VELHOR ( 29BRC17.0227)
- Conditions
- Horton Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- University Hospital, BrestUniversity, hospital or other
- Study start
- 2 Nov 2017 (actual)
- Primary completion
- 10 Dec 2017 (actual)
- Study completion
- 10 Dec 2017 (actual)
- First posted
- 4 Dec 2017 (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.
The use of ultrasonography in detecting giant cell arteritis ( GCA) is emerging. Currently, temporal biopsy is the gold standard to diagnose GCA but studies have shown the interest to use B mode ultrasonography. However, until now, the study of velocities in GCA have not been yet performed.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- all patients aged more than 55 years old who are suspected of giant arteritis
Key inclusion criteria (1 listed)
- patients with suspicious giant arteritis
Key exclusion criteria (1 listed)
- patients who have already been treated or diagnosed for giant arteritis
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
Velocimetric Study of Temporal Arteries in Patients With Horton Disease Using Scan-Doppler
Time frame: 2 months
velocimetric temporal arterial study in giant arteritis
1 secondary outcome
evaluation of the halo sign in giant arteritis using B mode ultrasonography
Time frame: 2 months
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 21 Apr 2020.
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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.
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 Horton Disease, 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 21 Apr 2020. 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?
Velocimetric Study of Temporal Arteries in Patients With Horton Disease Using Scan-Doppler (time frame: 2 months). 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 21 Apr 2020.