Ignite Creation Date:
2025-12-25 @ 2:07 AM
Ignite Modification Date:
2025-12-26 @ 1:18 AM
Study NCT ID:
NCT05193760
Status:
COMPLETED
Last Update Posted:
2023-02-14
First Post:
2021-12-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Robustness Check of Placement and Measurement Algorithms for Blood Flow Measurement on Common Carotid Artery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003324', 'term': 'Coronary Artery Disease'}, {'id': 'D000082862', 'term': 'Aortic Valve Disease'}], 'ancestors': [{'id': 'D003327', 'term': 'Coronary Disease'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D006349', 'term': 'Heart Valve Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 67}, 'targetDuration': '1 Day', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-10-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-02', 'completionDateStruct': {'date': '2022-09-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-02-13', 'studyFirstSubmitDate': '2021-12-23', 'studyFirstSubmitQcDate': '2022-01-14', 'lastUpdatePostDateStruct': {'date': '2023-02-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-01-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-09-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Robustness of placement and measurement algorithms.', 'timeFrame': 'During data acquisition, which is pre-surgery.', 'description': 'Using the obtained US images of the common carotid artery, the robustness of our algorithms for placement and measurements will be checked.'}, {'measure': 'Verify and improve the arterial blood flow model.', 'timeFrame': 'During data acquisition, which is pre-surgery.', 'description': 'Using the obtained US images of the common carotid artery, our arterial blood flow model will be verified and adapted.'}, {'measure': 'Orientation of ultrasound probe.', 'timeFrame': 'During data acquisition, which is pre-surgery.', 'description': 'Using the obtained US images of the common carotid artery, the influence of probe orientation on carotid artery parameters will be investigated.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Common carotid artery', 'Ultrasound'], 'conditions': ['Coronary Artery Disease', 'Aortic Valve Disease', 'Mitral Valve Disease']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': 'This study has four objectives:\n\n1. Determine the robustness of the placement and measurement algorithms with ultrasound images, obtained with different ultrasound system settings and probe movements.\n2. Verificate and optimize the arterial blood flow model.\n3. Determine the variation in location and size of the arteries and veins in the area around the common carotid artery.\n4. Determine the influence of probe orientation on parameters obtained from ultrasound measurements of the common carotid artery.\n\nSample 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adult (\\>18 years) cardiac surgery or TAVI patients.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult (\\>18 years) patients.\n* Participant should be able to provide informed consent in Dutch.\n\nExclusion Criteria:\n\n* Participant has a known stenosis of the carotid artery.\n* Patient has open wounds in the measurement area (area in the neck around the carotid artery).'}, 'identificationModule': {'nctId': 'NCT05193760', 'acronym': 'RAdiUS', 'briefTitle': 'Robustness Check of Placement and Measurement Algorithms for Blood Flow Measurement on Common Carotid Artery', 'organization': {'class': 'OTHER', 'fullName': 'Catharina Ziekenhuis Eindhoven'}, 'officialTitle': 'Robustness Check of Placement and Measurement Algorithms for Blood Flow Measurement on Common Carotid Artery', 'orgStudyIdInfo': {'id': 'ICBE 2-35542'}, 'secondaryIdInfos': [{'id': 'nWMO-2021.081', 'type': 'OTHER', 'domain': 'MEC-U'}]}, 'contactsLocationsModule': {'locations': [{'zip': '5652 EJ', 'city': 'Eindhoven', 'state': 'North Brabant', 'country': 'Netherlands', 'facility': 'Catharina Ziekenhuis Eindhoven', 'geoPoint': {'lat': 51.44083, 'lon': 5.47778}}], 'overallOfficials': [{'name': 'Arthur Bouwman, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Catharina Ziekenhuis Eindhoven'}, {'name': 'John van Rooij, MSc', 'role': 'STUDY_CHAIR', 'affiliation': 'Philips Electronics Nederland B.V.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Catharina Ziekenhuis Eindhoven', 'class': 'OTHER'}, 'collaborators': [{'name': 'Philips Electronics Nederland BV', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Doctoral Candidate', 'investigatorFullName': 'Esmée de Boer', 'investigatorAffiliation': 'Catharina Ziekenhuis Eindhoven'}}}}