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

Coronary Artery Disease Clinical Trial

— RAdiUS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05193760
• Other study ID #: ICBE 2-35542
• Secondary ID: nWMO-2021.081
• Status: Completed
• Start date: October 6, 2021
• Est. completion date: September 28, 2022

Study information

• Verified date: February 2023
• Source: Catharina Ziekenhuis Eindhoven
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 67
• Est. completion date: September 28, 2022
• Est. primary completion date: September 28, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Aortic Valve Disease
• Coronary Artery Disease
• Mitral Valve Disease

Locations

Country	Name	City	State
Netherlands	Catharina Ziekenhuis Eindhoven	Eindhoven	Noord-Brabant

Sponsors (2)

Lead Sponsor	Collaborator
Catharina Ziekenhuis Eindhoven	Philips Electronics Nederland BV

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Robustness of placement and measurement algorithms.	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.
Primary	Verify and improve the arterial blood flow model.	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.
Primary	Orientation of ultrasound probe.	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.