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

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: Recruiting
• Conditions: Superficial Temporal Artery

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: Observational
• Enrollment (Estimated): 700

Contacts and Locations

• Study Contact: Name: Brieg DISSAUX; Phone Number: +33 0298348034; Email: brieg.dissaux@chu-brest.fr

Study Locations

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

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort
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

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	12 months

Collaborators and Investigators

• Sponsor: University Hospital, Brest

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2023
• Primary Completion (Estimated): October 1, 2025
• Study Completion (Estimated): October 1, 2025

Study Registration Dates

• First Submitted: October 19, 2023
• First Submitted That Met QC Criteria: November 24, 2023
• First Posted (Estimated): December 5, 2023

Study Record Updates

• Last Update Posted (Estimated): December 5, 2023
• Last Update Submitted That Met QC Criteria: November 24, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Other Study ID 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