NCT05193760

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
67

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 6, 2021

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

December 23, 2021

Completed
26 days until next milestone

First Posted

Study publicly available on registry

January 18, 2022

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 28, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 28, 2022

Completed
Last Updated

February 14, 2023

Status Verified

February 1, 2023

Enrollment Period

12 months

First QC Date

December 23, 2021

Last Update Submit

February 13, 2023

Conditions

Coronary Artery DiseaseAortic Valve DiseaseMitral Valve Disease

Keywords

Common carotid arteryUltrasound

Outcome Measures

Primary Outcomes (3)

  • 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.

  • 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.

  • 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.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Catharina Ziekenhuis Eindhoven

Eindhoven, North Brabant, 5652 EJ, Netherlands

Location

MeSH Terms

Conditions

Coronary Artery DiseaseAortic Valve Disease

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular DiseasesHeart Valve Diseases

Study Officials

  • Arthur Bouwman, MD PhD

    Catharina Ziekenhuis Eindhoven

    PRINCIPAL INVESTIGATOR

  • John van Rooij, MSc

    Philips Electronics Nederland B.V.

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctoral Candidate

Study Record Dates

First Submitted

December 23, 2021

First Posted

January 18, 2022

Study Start

October 6, 2021

Primary Completion

September 28, 2022

Study Completion

September 28, 2022

Last Updated

February 14, 2023

Record last verified: 2023-02

Locations

NL(1)