Ignite Creation Date:
2025-12-26 @ 11:08 AM
Ignite Modification Date:
2026-01-13 @ 7:17 PM
Study NCT ID:
NCT02517112
Status:
UNKNOWN
Last Update Posted:
2015-08-06
First Post:
2015-07-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
3D Ballistocardiography in Microgravity
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 18}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2011-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-08', 'lastUpdateSubmitDate': '2015-08-05', 'studyFirstSubmitDate': '2015-07-23', 'studyFirstSubmitQcDate': '2015-08-05', 'lastUpdatePostDateStruct': {'date': '2015-08-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-08-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Heart rate', 'timeFrame': 'baseline', 'description': 'evaluated by BCG, ECG, ICG and echocardiography during the free-floating protocol'}, {'measure': 'stroke volume', 'timeFrame': 'baseline', 'description': 'evaluated by BCG, ECG, ICG and echocardiography during the free-floating protocol'}, {'measure': 'ejection fraction', 'timeFrame': 'baseline', 'description': 'evaluated by BCG, ECG, ICG and echocardiography during the free-floating protocol'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['volunteers'], 'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': '3-D Ballistocardiography (BCG) recording was performed in microgravity during the Spacelab D2 missions on a single astronaut. The results from this experiment have been published in the literature: the influence of respiration have been demonstrated and the signal processing methodology for the reconstruction of the displacement in one cardiac cycle have been developed. A 3D-BCG sensor has been developed and a collaboration to perform a sustained microgravity experiment onboard the Russian segment of ISS has been initiated. To be integrated in the PNEUMOCARD device, this new sensor needs to be tested in microgravity before implemented on ISS.\n\nThe aim of the present parabolic flight study is to serve as a feasibility demonstrator and test bed in order to evaluate the feasibility of 3D-BCG in sustained microgravity and to test whether the sensitivity of the developed 3D-BCG sensor is appropriate'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy volunteers (men or women)\n* Aged from 18 to 65\n* Affiliated to a Social Security system and, for non-French resident, holding a European Health Insurance Card (EHIC)\n* Who accepted to take part in the study\n* Who have given their written stated consent\n* Whose 4 chamber view of the heart during a breath hold is easy to get during a routine cardiac echocardiography (M-Mode - apical view).\n* Who has passed a medical examination similar to a standard aviation medical examination for private pilot aptitude (JAR FCL3 Class 2 medical examination). There will be no additional test performed for subject selection.\n\nExclusion Criteria:\n\n* Person who took part in a previous biomedical research protocol, of which exclusion period is not terminated\n* Difficulty to obtain a clear echocardiography.\n* Pregnant women'}, 'identificationModule': {'nctId': 'NCT02517112', 'acronym': 'B3D', 'briefTitle': '3D Ballistocardiography in Microgravity', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Caen'}, 'orgStudyIdInfo': {'id': '11-126'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Cardiovascular parameters measurements', 'interventionNames': ['Other: Parabolic flight', 'Other: Cardiovascular parameters measurements', 'Device: 3D-BCG sensor']}], 'interventions': [{'name': 'Parabolic flight', 'type': 'OTHER', 'armGroupLabels': ['Cardiovascular parameters measurements']}, {'name': 'Cardiovascular parameters measurements', 'type': 'OTHER', 'description': 'with Ballistocardiography (BCG), electric cardiography (ECG), impedance cardiography (ICG) and echocardiography', 'armGroupLabels': ['Cardiovascular parameters measurements']}, {'name': '3D-BCG sensor', 'type': 'DEVICE', 'armGroupLabels': ['Cardiovascular parameters measurements']}]}, 'contactsLocationsModule': {'locations': [{'zip': '14032', 'city': 'Caen', 'state': 'Basse-Normandie', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Pierre Denise, MD PhD', 'role': 'CONTACT', 'email': 'pierre.denise@unicaen.fr', 'phone': '332068214'}], 'facility': 'Umr Ucbn/Inserm U1075 Comete', 'geoPoint': {'lat': 49.18585, 'lon': -0.35912}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Caen', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}