Ignite Creation Date:
2025-12-24 @ 2:08 PM
Ignite Modification Date:
2025-12-24 @ 2:08 PM
Study NCT ID:
NCT04336995
Status:
COMPLETED
Last Update Posted:
2024-04-09
First Post:
2020-04-03
Is Possible Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Exercise Pulmonary Transit Time
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2022-06-21', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D054144', 'term': 'Heart Failure, Diastolic'}], 'ancestors': [{'id': 'D006333', 'term': 'Heart Failure'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004452', 'term': 'Echocardiography'}], 'ancestors': [{'id': 'D057791', 'term': 'Cardiac Imaging Techniques'}, {'id': 'D003952', 'term': 'Diagnostic Imaging'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D014463', 'term': 'Ultrasonography'}, {'id': 'D006334', 'term': 'Heart Function Tests'}, {'id': 'D003935', 'term': 'Diagnostic Techniques, Cardiovascular'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ken.monahan@vanderbilt.edu', 'phone': '6153222318', 'title': 'Ken Monahan', 'organization': 'VUMC'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'day of study', 'eventGroups': [{'id': 'EG000', 'title': 'Exercise', 'description': 'Everyone is in this arm\n\ncontrast echocardiography: giving echocardiographic contrast and taking echocardiographic images before and after exercise', 'otherNumAtRisk': 14, 'deathsNumAtRisk': 14, 'otherNumAffected': 0, 'seriousNumAtRisk': 14, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Pulmonary Transit Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Exercise', 'description': 'Everyone is in this arm\n\ncontrast echocardiography: giving echocardiographic contrast and taking echocardiographic images before and after exercise'}], 'classes': [{'categories': [{'measurements': [{'value': '2.5', 'spread': '0.5', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '3-10 seconds', 'description': 'interval required for the pulmonary blood volume to traverse the pulmonary circulation', 'unitOfMeasure': 'seconds', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Exercise', 'description': 'Everyone is in this arm\n\ncontrast echocardiography: giving echocardiographic contrast and taking echocardiographic images before and after exercise'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Exercise', 'description': 'Everyone is in this arm\n\ncontrast echocardiography: giving echocardiographic contrast and taking echocardiographic images before and after exercise'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '46', 'spread': '8', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '12', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '13', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '14', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-04-01', 'size': 110982, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2022-05-20T19:12', 'hasProtocol': True}, {'date': '2021-04-20', 'size': 769084, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2024-04-04T17:12', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'small pilot study to test technical feasibility'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 14}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-08-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2024-03-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-04-05', 'studyFirstSubmitDate': '2020-04-03', 'resultsFirstSubmitDate': '2022-05-20', 'studyFirstSubmitQcDate': '2020-04-03', 'lastUpdatePostDateStruct': {'date': '2024-04-09', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2022-06-19', 'studyFirstPostDateStruct': {'date': '2020-04-07', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2022-07-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-08-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pulmonary Transit Time', 'timeFrame': '3-10 seconds', 'description': 'interval required for the pulmonary blood volume to traverse the pulmonary circulation'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Heart Failure, Diastolic']}, 'descriptionModule': {'briefSummary': 'The study seeks to measure pulmonary transit time via contrast-echocardiography before and after exercise.', 'detailedDescription': "The ability to measure the amount of blood in the lungs using heart-ultrasound (echocardiography) can be useful to estimate how much fluid is in a patient's circulation, which can influence diagnosis and treatment of certain types of heart failure. In some patients, the amount of fluid is normal at rest, but can increase with activity and thus a diagnosis of heart failure can only be made after exercising. Currently, the amount of fluid is measured invasively. We have shown that echocardiography can measure the amount of fluid in the lung circulation at rest without the need for an invasive procedure. We now seek to find out if we can make a similar measurement after exercise. If successful, the need for catheter procedures may be reduced in certain types of heart failure."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age ≥ 18 years old\n2. Able to give informed consent\n\nExclusion Criteria:\n\n1. Known allergic reaction to Definity or Optison ultrasound contrast\n2. Pregnancy/Nursing - as assessed/disclosed by the participant'}, 'identificationModule': {'nctId': 'NCT04336995', 'briefTitle': 'Exercise Pulmonary Transit Time', 'organization': {'class': 'OTHER', 'fullName': 'Vanderbilt University Medical Center'}, 'officialTitle': 'Echocardiographic Assessment of Pulmonary Transit Time Following Exercise', 'orgStudyIdInfo': {'id': 'IRB200429'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Exercise', 'description': 'Everyone is in this arm', 'interventionNames': ['Diagnostic Test: contrast echocardiography']}], 'interventions': [{'name': 'contrast echocardiography', 'type': 'DIAGNOSTIC_TEST', 'description': 'giving echocardiographic contrast and taking echocardiographic images before and after exercise', 'armGroupLabels': ['Exercise']}]}, 'contactsLocationsModule': {'locations': [{'zip': '37232', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'VHVI', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}], 'overallOfficials': [{'name': 'Ken Monahan, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'VUMC'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Vanderbilt University Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor of Medicine', 'investigatorFullName': 'Ken Monahan', 'investigatorAffiliation': 'Vanderbilt University Medical Center'}}}}