Coronary Artery DiseaseRAdiUSNCT05193760
Robustness Check of Placement and Measurement Algorithms for Blood Flow Measurement on Common Carotid Artery
An observational study of Coronary Artery Disease and Aortic Valve Disease, run by Catharina Ziekenhuis Eindhoven at 1 site in Netherlands.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease, Aortic Valve Disease, Mitral Valve Disease
- How many people
- 67 participants
- Where
- 1 siteNetherlands
- Study dates
- 6 Oct 2021to 28 Sep 2022
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult (>18 years) cardiac surgery or TAVI patients.
Who may be able to join
- Adult (>18 years) patients.
- Participant should be able to provide informed consent in Dutch.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Catharina Ziekenhuis Eindhoven
Eindhoven, North Brabant, 5652 EJ
About this study
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.
Read the detailed description
This study has four objectives:
- Determine the robustness of the placement and measurement algorithms with ultrasound images, obtained with different ultrasound system settings and probe movements.
- Verificate and optimize the arterial blood flow model.
- Determine the variation in location and size of the arteries and veins in the area around the common carotid artery.
- 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.
- Keywords
- Common carotid artery, Ultrasound
- Medical subject headings
- Coronary Artery Disease, Aortic Valve Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: During data acquisition, which is pre-surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2022
- Study start6 Oct 2021
- Primary completion28 Sep 2022
- Study completion28 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 67 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Catharina Ziekenhuis Eindhoven
- Sponsor type
- University, hospital or other
- Collaborators
- Philips Electronics Nederland BV
- Responsible party
- Principal investigator, Esmée de Boer, Catharina Ziekenhuis Eindhoven
- Investigators
- Arthur Bouwman, MD PhD, Principal investigator, Catharina Ziekenhuis EindhovenJohn van Rooij, MSc, Study chair, Philips Electronics Nederland B.V.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05193760
- Sponsor's protocol ID
- ICBE 2-35542
- Other IDs
- nWMO-2021.081
- Acronym
- RAdiUS
- Status last verified
- Feb 2023
- First submitted
- 23 Dec 2021
- Last updated
- 14 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Robustness Check of Placement and Measurement Algorithms for Blood Flow Measurement on Common Carotid Artery
- ClinicalTrials.gov ID
- NCT05193760
- Acronym / sponsor ID
- RAdiUS / ICBE 2-35542
- Keywords
- Common carotid artery, Ultrasound
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- Catharina Ziekenhuis EindhovenUniversity, hospital or other
- Collaborators
- Philips Electronics Nederland BV
- Study start
- 6 Oct 2021 (actual)
- Primary completion
- 28 Sep 2022 (actual)
- Study completion
- 28 Sep 2022 (actual)
- First posted
- 18 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This study has four objectives:
- Determine the robustness of the placement and measurement algorithms with ultrasound images, obtained with different ultrasound system settings and probe movements.
- Verificate and optimize the arterial blood flow model.
- Determine the variation in location and size of the arteries and veins in the area around the common carotid artery.
- 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 design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult (>18 years) cardiac surgery or TAVI patients.
Key inclusion criteria (2 listed)
- Adult (>18 years) patients.
- Participant should be able to provide informed consent in Dutch.
Key exclusion criteria (2 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Arthur Bouwman, MD PhD principal investigator
Catharina Ziekenhuis Eindhoven
John van Rooij, MSc study chair
Philips Electronics Nederland B.V.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Disease and Aortic Valve Disease, run by Catharina Ziekenhuis Eindhoven at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Robustness of placement and measurement algorithms. (time frame: During data acquisition, which is pre-surgery.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Feb 2023.