Superficial Temporal ArteryEVATSINCT06155864
Imaging Study of Anatomical Variations of the Superficial Temporal Artery (EVATSI)
An observational study of Superficial Temporal Artery, run by University Hospital, Brest at 2 sites in France.
Trial summary
This study focuses on the anatomy of the superficial temporal artery, an artery of the head. Knowledge of the anatomy of this artery, and the evaluation of methods for exploring it, have implications for clinical medical and surgical practice. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Superficial Temporal Artery
- How many people
- 700 participants
- Where
- 2 sitesFrance
- Study dates
- 1 Oct 2023to 1 Oct 2025
- 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 18 years and older
- All sexes
- Adult, Older adult
Study population: Patients who underwent "Polygon of Willis" imaging of the arteries of the head in the medical imaging department of Brest University Hospital.
Who may be able to join
- No opposition expressed
- Examination analyzable
Who cannot join
- Refusal to participate
Trial locations and contacts
2 sites in 1 country.
France2 sites, 1 recruiting
- Recruiting
Chu Brest
Brest, 29609
- Active, not recruiting
Chu Brest
Brest, 29609
About this study
Official title: Imaging Study of Anatomical Variations of the Superficial Temporal Artery
This study focuses on the anatomy of the superficial temporal artery, an artery of the head. Knowledge of the anatomy of this artery, and the evaluation of methods for exploring it, have implications for clinical medical and surgical practice.
Read the detailed description
The study will be divided into several parts:
- The aim is to study the reproducibility of anatomical measurements of the superficial temporal artery using CTA.
- The aim is to study the contribution of CTA for the anatomical assessment of the superficial temporal artery.
- The aim is to evaluate the performance of MRI in the anatomical study of the superficial temporal artery.
- Conditions
- Superficial Temporal Artery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | To study the reproducibility of anatomical measurements of the superficial temporal artery using X-ray angio-modensitometry. | |
| 2 | Investigate different CT techniques for studying the superficial temporal artery. | |
| 3 | Study the anatomy of the superficial temporal artery on CT. | |
| 4 | Study the anatomy of the superficial temporal artery on MRI. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intra- and inter-observer reproducibility of anatomical criteria of the superficial temporal artery in CTA.
The aim is to study the reproducibility of anatomical measurements of the superficial temporal artery. To this end, an intra-class agreement (ICA) analysis will be performed to assess the inter-observer and intra-observer reliability of the measurements. We will also calculate the standard error of measurement (SEM) to assess measurement variability, and perform a Bland-Altman analysis to visualize differences between measurements.
Measured: 12 months
Evaluation of anatomical measurements and reproducibility of measurements obtained with an iterative and classical reconstruction CT technique.
The aim is to compare the performance of the two reconstruction techniques (conventional and iterative) for anatomical assessment of the superficial temporal artery. A repeated-measures analysis of variance can be performed to compare the measurements obtained with the two reconstruction techniques.ICCs and TEMs will also be calculated to assess the reproducibility of measurements with each technique.
Measured: 12 months
Study the anatomy of the superficial temporal artery in a large number of patients, and to correlate the anatomical variants observed with the age of the subjects.
The aim is to study the anatomy of the superficial temporal artery in a large number of patients, and to correlate the anatomical variants observed with the age of the subjects. Descriptive data analysis will be carried out to describe the characteristics of the study population (age, sex, etc.) and the anatomical measurements of the superficial temporal artery.We will use linear regression analysis to assess this relationship and determine the importance of each explanatory variable. We will also assess goodness of fit using measures such as the coefficient of determination R2.
Measured: 12 months
The aim is to compare the performance of arterial time-of-flight (TOF) sequences in MRI at 1.5T and 3T with angio-CT. A comparative analysis of the anatomical measurements obtained with each technique will be carried out.
The aim is to compare the performance of arterial time-of-flight (TOF) sequences in MRI at 1.5T and 3T with angio-CT. A comparative analysis of the anatomical measurements obtained with each technique will be carried out, using t-tests or non-parametric tests depending on the distribution of the data. Concordance between measurements obtained with each technique will be assessed using ICC and Pearson's correlation coefficient.We will seek to identify homogeneous groups of subjects based on their characteristics. We will use cluster analysis to determine the distance between subjects and group them into homogeneous clusters.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2023
- Study start1 Oct 2023
- Primary completion1 Oct 2025 (estimated)
- Study completion1 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Superficial Temporal ArteryStudies 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
- 700 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Brest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06155864
- Sponsor's protocol ID
- 29BRC23.0119 - EVATSI
- Acronym
- EVATSI
- Status last verified
- Nov 2023
- First submitted
- 19 Oct 2023
- Last updated
- 5 Dec 2023
- 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 5 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Imaging Study of Anatomical Variations of the Superficial Temporal Artery
- ClinicalTrials.gov ID
- NCT06155864
- Acronym / sponsor ID
- EVATSI / 29BRC23.0119 - EVATSI
- Conditions
- Superficial Temporal Artery
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 700 participants (estimated)
- Lead sponsor
- University Hospital, BrestUniversity, hospital or other
- Study start
- 1 Oct 2023 (actual)
- Primary completion
- 1 Oct 2025 (estimated)
- Study completion
- 1 Oct 2025 (estimated)
- First posted
- 5 Dec 2023 (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.
This study focuses on the anatomy of the superficial temporal artery, an artery of the head. Knowledge of the anatomy of this artery, and the evaluation of methods for exploring it, have implications for clinical medical and surgical practice.
Detailed description
The study will be divided into several parts:
- The aim is to study the reproducibility of anatomical measurements of the superficial temporal artery using CTA.
- The aim is to study the contribution of CTA for the anatomical assessment of the superficial temporal artery.
- The aim is to evaluate the performance of MRI in the anatomical study of the superficial temporal artery.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –To study the reproducibility of anatomical measurements of the superficial temporal artery using X-ray angio-modensitometry. |
| 2 | – | –Investigate different CT techniques for studying the superficial temporal artery. |
| 3 | – | –Study the anatomy of the superficial temporal artery on CT. |
| 4 | – | –Study the anatomy of the superficial temporal artery on MRI. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients who underwent "Polygon of Willis" imaging of the arteries of the head in the medical imaging department of Brest University Hospital.
Key inclusion criteria (2 listed)
- No opposition expressed
- Examination analyzable
Key exclusion criteria (1 listed)
- Refusal 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
Intra- and inter-observer reproducibility of anatomical criteria of the superficial temporal artery in CTA.
Time frame: 12 months
The aim is to study the reproducibility of anatomical measurements of the superficial temporal artery. To this end, an intra-class agreement (ICA) analysis will be performed to assess the inter-observer and intra-observer reliability of the measurements. We will also calculate the standard error of measurement (SEM) to assess measurement variability, and perform a Bland-Altman analysis to visualize differences between measurements.
Evaluation of anatomical measurements and reproducibility of measurements obtained with an iterative and classical reconstruction CT technique.
Time frame: 12 months
The aim is to compare the performance of the two reconstruction techniques (conventional and iterative) for anatomical assessment of the superficial temporal artery. A repeated-measures analysis of variance can be performed to compare the measurements obtained with the two reconstruction techniques.ICCs and TEMs will also be calculated to assess the reproducibility of measurements with each technique.
Study the anatomy of the superficial temporal artery in a large number of patients, and to correlate the anatomical variants observed with the age of the subjects.
Time frame: 12 months
The aim is to study the anatomy of the superficial temporal artery in a large number of patients, and to correlate the anatomical variants observed with the age of the subjects. Descriptive data analysis will be carried out to describe the characteristics of the study population (age, sex, etc.) and the anatomical measurements of the superficial temporal artery.We will use linear regression analysis to assess this relationship and determine the importance of each explanatory variable. We will also assess goodness of fit using measures such as the coefficient of determination R2.
The aim is to compare the performance of arterial time-of-flight (TOF) sequences in MRI at 1.5T and 3T with angio-CT. A comparative analysis of the anatomical measurements obtained with each technique will be carried out.
Time frame: 12 months
The aim is to compare the performance of arterial time-of-flight (TOF) sequences in MRI at 1.5T and 3T with angio-CT. A comparative analysis of the anatomical measurements obtained with each technique will be carried out, using t-tests or non-parametric tests depending on the distribution of the data. Concordance between measurements obtained with each technique will be assessed using ICC and Pearson's correlation coefficient.We will seek to identify homogeneous groups of subjects based on their characteristics. We will use cluster analysis to determine the distance between subjects and group them into homogeneous clusters.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2023.
- Individual participant dataSharing planned: Yes. All collected data that underlie results in a publication
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Superficial Temporal Artery, run by University Hospital, Brest at 2 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 2 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: status not confirmed, as of the sponsor's last update on 5 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Brieg DISSAUX (0298348034 ext. +33, brieg.dissaux@chu-brest.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intra- and inter-observer reproducibility of anatomical criteria of the superficial temporal artery in CTA. (time frame: 12 months). The study lists 4 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 5 Dec 2023.