Robustness Check of Placement and Measurement Algorithms for Blood Flow Measurement on Common Carotid Artery (RAdiUS)

February 13, 2023 updated by: Esmée de Boer, Catharina Ziekenhuis Eindhoven
This study is set up to test the robustness of algorithms and models and to optimize them. Furthermore, data are used to investigate the influence of probe orientation on parameters of the common carotid artery.

Study Overview

Status

Completed

Conditions

Detailed Description

This study has four objectives:

  1. Determine the robustness of the placement and measurement algorithms with ultrasound images, obtained with different ultrasound system settings and probe movements.
  2. Verificate and optimize the arterial blood flow model.
  3. Determine the variation in location and size of the arteries and veins in the area around the common carotid artery.
  4. Determine the influence of probe orientation on parameters obtained from ultrasound measurements of the common carotid artery.

Sample size and missing data Due to limited time in the operating room, the measurement protocol is divided into four parts. Per protocol part data of 25 patients is deemed sufficient to be able to answer the above-mentioned objectives, which would result in a total of 100 inclusions. However, the investigators expect to perform more than one measurement protocol per patient, due to which a total of 75 inclusions is needed. Patients of whom the data is qualitatively too low to be used for analysis will be replaced. As such, the investigators make sure to have qualitatively good data of 25 patients per protocol part.

Study Type

Observational

Enrollment (Actual)

67

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

  • Netherlands
    • Noord-Brabant
      • Eindhoven, Noord-Brabant, Netherlands, 5652 EJ
        • Catharina Ziekenhuis Eindhoven

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

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Adult (>18 years) cardiac surgery or TAVI patients.

Description

Inclusion Criteria:

  • Adult (>18 years) patients.
  • Participant should be able to provide informed consent in Dutch.

Exclusion Criteria:

  • Participant has a known stenosis of the carotid artery.
  • Patient has open wounds in the measurement area (area in the neck around the carotid artery).

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
Robustness of placement and measurement algorithms.
Time Frame: During data acquisition, which is pre-surgery.
Using the obtained US images of the common carotid artery, the robustness of our algorithms for placement and measurements will be checked.
During data acquisition, which is pre-surgery.
Verify and improve the arterial blood flow model.
Time Frame: During data acquisition, which is pre-surgery.
Using the obtained US images of the common carotid artery, our arterial blood flow model will be verified and adapted.
During data acquisition, which is pre-surgery.
Orientation of ultrasound probe.
Time Frame: During data acquisition, which is pre-surgery.
Using the obtained US images of the common carotid artery, the influence of probe orientation on carotid artery parameters will be investigated.
During data acquisition, which is pre-surgery.

Collaborators and Investigators

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

Sponsor

Catharina Ziekenhuis Eindhoven

Collaborators

Philips Electronics Nederland BV

Investigators

  • Principal Investigator: Arthur Bouwman, MD PhD, Catharina Ziekenhuis Eindhoven
  • Study Chair: John van Rooij, MSc, Philips Electronics Nederland B.V.

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)

October 6, 2021

Primary Completion (ACTUAL)

September 28, 2022

Study Completion (ACTUAL)

September 28, 2022

Study Registration Dates

First Submitted

December 23, 2021

First Submitted That Met QC Criteria

January 14, 2022

First Posted (ACTUAL)

January 18, 2022

Study Record Updates

Last Update Posted (ESTIMATE)

February 14, 2023

Last Update Submitted That Met QC Criteria

February 13, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ICBE 2-35542
  • nWMO-2021.081 (OTHER: MEC-U)

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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