Imaging Study of Anatomical Variations of the Superficial Temporal Artery (EVATSI) (EVATSI)

November 24, 2023 updated by: University Hospital, Brest

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
700

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • France
      • Brest, France, 29609
        • Recruiting
        • CHU Brest
      • Brest, France, 29609
        • Active, not recruiting
        • CHU Brest

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

Patients who underwent "Polygon of Willis" imaging of the arteries of the head in the medical imaging department of Brest University Hospital.

Description

Inclusion Criteria:

  • No opposition expressed
  • Examination analyzable

Exclusion Criteria:

  • Refusal 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

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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 the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
12 months
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.
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.
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.
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.
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.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University Hospital, Brest

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 19, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 24, 2023

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 5, 2023

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 5, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 24, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 29BRC23.0119 - EVATSI

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 three years and ending fifth years following the final study report completion

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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