Ignite Creation Date:
2025-12-26 @ 10:58 AM
Ignite Modification Date:
2025-12-30 @ 9:01 AM
Study NCT ID:
NCT03504306
Status:
COMPLETED
Last Update Posted:
2019-01-15
First Post:
2018-03-15
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Validation of Ventriject Determined Maximal Oxygen Uptake
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'blood samples for testing blood values'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-04-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-01', 'completionDateStruct': {'date': '2018-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-01-13', 'studyFirstSubmitDate': '2018-03-15', 'studyFirstSubmitQcDate': '2018-04-11', 'lastUpdatePostDateStruct': {'date': '2019-01-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-04-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Comparing how well the Ventriject software can estimate VO2 max', 'timeFrame': '4 months data collection, although cross sectional', 'description': 'VO2 max tested on bike with online software Ventriject will estimate VO2max based on ECG, echoseismography and echosonography obtained at rest'}], 'secondaryOutcomes': [{'measure': 'comparing how well the measurements from the mobile phone test compare to the same measurements with accelerometer and echosonography', 'timeFrame': '4 months data collection, although cross sectional', 'description': 'comparison of ECG, echoseismography and echosonography obtained at rest to a measurement of movement (caused by heart contraction) by mobile phone, also at rest'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'This study aims to validate the use of the Ventriject product to estimate VO2 max, through a non-physically active test using ECG, echoseismography and echosonography.', 'detailedDescription': 'this study will be composed of the following tests:\n\n* blood sample for measurement of blood values\n* blood pressure measurement to rule out risks affiliated with maximal effort testing\n* DXA body composition scanning\n* Measurement on ECG, echosonography and echoseismography with accelerometer, microphone and ECG wires\n* Measurements with phone (iPhone)\n* VO2 max assessment by maximal oxygen uptake testing on a training bike, using online oxygenmeasurement equipment\n* Hand-grip strength assessment'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'genderBased': True, 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'healthy adults', 'genderDescription': '50/50 gender composition, meaning uptake of participants of a gender will end when the group reaches 50 participants', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\- healthy adults between 18 and 45 years of age\n\nExclusion Criteria:\n\n* current or previous cardiovascular disease\n* chronic use of medicine\n* pregnancy\n* illnesses which prohibits the testing of maximal oxygen uptake'}, 'identificationModule': {'nctId': 'NCT03504306', 'briefTitle': 'Validation of Ventriject Determined Maximal Oxygen Uptake', 'organization': {'class': 'OTHER', 'fullName': 'University of Copenhagen'}, 'officialTitle': 'Validation of Ventriject Determined Maximal Oxygen Uptake', 'orgStudyIdInfo': {'id': 'Ventriject1'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Ventriject validation', 'type': 'OTHER', 'description': 'comparing measurements from echocardiography, echoseismography to measurements of maximal oxygen uptake'}]}, 'contactsLocationsModule': {'locations': [{'zip': '2200', 'city': 'Copenhagen', 'country': 'Denmark', 'facility': 'Xlab, Faculty of Health and Medical Sciences, University of Copenhagen', 'geoPoint': {'lat': 55.67594, 'lon': 12.56553}}], 'overallOfficials': [{'name': 'Jørn W Helge, Prof.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'jhelge@sund.ku'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'Sharing of IPD is possible if the following terms are met:\n\n1. Identification of the study participant is in no way achieveable from the requested data\n2. The participant declares interest in their data being shared through IPD'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Copenhagen', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prof. Jørn Wulff Helge', 'investigatorFullName': 'Jørn Wulff Helge', 'investigatorAffiliation': 'University of Copenhagen'}}}}