Ignite Creation Date:
2025-12-25 @ 2:11 AM
Ignite Modification Date:
2026-01-04 @ 9:48 PM
Study NCT ID:
NCT03802760
Status:
COMPLETED
Last Update Posted:
2022-11-08
First Post:
2018-10-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cerebral Microembolism in Cardiology
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020766', 'term': 'Intracranial Embolism'}], 'ancestors': [{'id': 'D002542', 'term': 'Intracranial Embolism and Thrombosis'}, {'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D013923', 'term': 'Thromboembolism'}, {'id': 'D016769', 'term': 'Embolism and Thrombosis'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D017585', 'term': 'Ultrasonography, Doppler, Transcranial'}], 'ancestors': [{'id': 'D004453', 'term': 'Echoencephalography'}, {'id': 'D009485', 'term': 'Neuroradiography'}, {'id': 'D059906', 'term': 'Neuroimaging'}, {'id': 'D003952', 'term': 'Diagnostic Imaging'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D011859', 'term': 'Radiography'}, {'id': 'D014463', 'term': 'Ultrasonography'}, {'id': 'D018608', 'term': 'Ultrasonography, Doppler'}, {'id': 'D003943', 'term': 'Diagnostic Techniques, Neurological'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-10-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-11', 'completionDateStruct': {'date': '2022-11-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-11-07', 'studyFirstSubmitDate': '2018-10-22', 'studyFirstSubmitQcDate': '2019-01-10', 'lastUpdatePostDateStruct': {'date': '2022-11-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-01-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-02-24', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Quality of cerebral microemboli (solid vs. gaseous)', 'timeFrame': 'intraoperative phase, expected to be approx. 4 hours', 'description': 'The quality of cerebral microemboli is measured by Doppler ultrasonography which automatically detects and analyses the Doppler signal coming from the middle cerebral artery. According to the strength of signal reflection, the signal will be qualified as solid or gaseous.'}], 'secondaryOutcomes': [{'measure': 'Quantity of cerebral microemboli load', 'timeFrame': 'intraoperative phase, expected to be approx. 4 hours', 'description': 'The quantity of cerebral microemboli is measured by Doppler ultrasonography which automatically register the counts of solid and gaseous emboli.'}, {'measure': 'Cerebral hemispheric differences (left vs. right)', 'timeFrame': 'intraoperative phase, expected to be approx. 4 hours'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cerebral Embolism']}, 'descriptionModule': {'briefSummary': 'During different interventional cardiology procedures we aim to identify cerebral microemboli load. Further we aim to differentiate the quality and the quantity of cerebral microemboli.We will measure cerebral microemboli in different interventional phases, e.g. during valve deployment, rapid pacing, post-implantation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients undergoing Interventional cardiology procedure (TAVI, MitraClip, TricuspidalClip)', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age \\> 18 years\n* Interventional cardiology procedure (TAVI, MitraClip, TricuspidalClip)\n\nExclusion Criteria:\n\n* Allergy to ultrasound gel or materials contained in the TCD probe\n* Missing temporal bone window'}, 'identificationModule': {'nctId': 'NCT03802760', 'acronym': 'ZEMEK', 'briefTitle': 'Cerebral Microembolism in Cardiology', 'organization': {'class': 'OTHER', 'fullName': 'Insel Gruppe AG, University Hospital Bern'}, 'officialTitle': 'Cerebral Microembolism in Interventional Cardiology Procedures', 'orgStudyIdInfo': {'id': '2018-01066'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'TAVI patients', 'description': 'Patients undergoing transfemoral TAVI', 'interventionNames': ['Device: Transcranial Doppler (TCD) ultrasound measurement']}, {'label': 'MitraClip patients', 'description': 'Patients undergoing MitraClip implantation', 'interventionNames': ['Device: Transcranial Doppler (TCD) ultrasound measurement']}, {'label': 'TricuspidalClip', 'description': 'Patients undergoing TricuspidalClip implantation', 'interventionNames': ['Device: Transcranial Doppler (TCD) ultrasound measurement']}], 'interventions': [{'name': 'Transcranial Doppler (TCD) ultrasound measurement', 'type': 'DEVICE', 'description': 'Non-invasive measurement of cerebral embolic load and blood flow using TCD', 'armGroupLabels': ['MitraClip patients', 'TAVI patients', 'TricuspidalClip']}]}, 'contactsLocationsModule': {'locations': [{'zip': '3010', 'city': 'Bern', 'country': 'Switzerland', 'facility': 'Department of Anesthesiology and Pain Medicine', 'geoPoint': {'lat': 46.94809, 'lon': 7.44744}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Insel Gruppe AG, University Hospital Bern', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Gabor Erdös', 'investigatorAffiliation': 'Insel Gruppe AG, University Hospital Bern'}}}}