Ignite Creation Date:
2025-12-24 @ 9:59 PM
Ignite Modification Date:
2025-12-28 @ 2:17 PM
Study NCT ID:
NCT05700032
Status:
WITHDRAWN
Last Update Posted:
2024-09-04
First Post:
2023-01-17
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Impact of High Mechanical Index Ultrasound Impulses on Left Ventricular Stroke Volume With Intravenous Microbubbles
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006331', 'term': 'Heart Diseases'}], 'ancestors': [{'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Due to clinical service demand study was withdrawn and not activated', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2021-02-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2021-02-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-08-30', 'studyFirstSubmitDate': '2023-01-17', 'studyFirstSubmitQcDate': '2023-01-17', 'lastUpdatePostDateStruct': {'date': '2024-09-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-01-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-02-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Left Ventricle Outflow Tract (LVOT) First Ventilatory Threshold VTI', 'timeFrame': '10 minutes', 'description': 'Left Ventricle Outflow Tract (LVOT) First Ventilatory Threshold VTI'}], 'secondaryOutcomes': [{'measure': 'stroke volume', 'timeFrame': '10 minutes', 'description': 'The volume of blood pumped out of the left ventricle of the heart during each systolic cardiac contraction'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Cardiac Disease']}, 'descriptionModule': {'briefSummary': 'This study will investigate whether applying high mechanical index (MI) impulses from a diagnostic ultrasound transducer when using ultrasound enhancing agent (UEA) microbubble infusion will result in subclinical improvement in left ventricle systolic function.', 'detailedDescription': 'The purpose of this study is to investigate whether applying high MI impulses from a diagnostic ultrasound transducer when using ultrasound enhancing agent(UEA) microbubble infusion will result in subclinical improvement in LV systolic function detected by left ventricular outflow tract velocity time integral (LVOT VTI).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nage 19 years or older\n\nExclusion Criteria:\n\n1. severe aortic valve stenosis\n2. pregnant or lactating women\n3. atrial fibrillation\n4. very poor image quality despite contrast use.\n5. unstable cardiac condition such as cardiogenic shock.\n6. allergy to UEA\n7. presence of right to left or bidirectional shunts.\n8. Patients on mechanical circulatory support.'}, 'identificationModule': {'nctId': 'NCT05700032', 'acronym': 'MI', 'briefTitle': 'Impact of High Mechanical Index Ultrasound Impulses on Left Ventricular Stroke Volume With Intravenous Microbubbles', 'organization': {'class': 'OTHER', 'fullName': 'University of Nebraska'}, 'officialTitle': 'The Impact of High Mechanical Index Ultrasound Impulses on Left Ventricular Stroke Volume in Patients Receiving Intravenous Microbubbles', 'orgStudyIdInfo': {'id': '0134-20-FB'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'high MI', 'description': 'patients receiving high MI impulses', 'interventionNames': ['Diagnostic Test: high MI impulses']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'low MI', 'description': 'patients receiving low MI impulses', 'interventionNames': ['Diagnostic Test: low MI impulses']}], 'interventions': [{'name': 'high MI impulses', 'type': 'DIAGNOSTIC_TEST', 'description': 'patients will receive intermittent high MI impulses(\\>1.0) in addition to low MI imaging. LVOT VTI will be measured at different times per protocol.', 'armGroupLabels': ['high MI']}, {'name': 'low MI impulses', 'type': 'DIAGNOSTIC_TEST', 'description': 'patients will receive low MI imaging only. LVOT VTI will be measured at different times per protocol.', 'armGroupLabels': ['low MI']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Swethika Harini Sundaravel, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Nebraska'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Nebraska', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}