Ignite Creation Date:
2025-12-25 @ 12:16 AM
Ignite Modification Date:
2026-01-02 @ 3:07 PM
Study NCT ID:
NCT04221958
Status:
WITHDRAWN
Last Update Posted:
2025-05-04
First Post:
2020-01-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Surface ECG Mapping
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D004562', 'term': 'Electrocardiography'}], 'ancestors': [{'id': 'D006334', 'term': 'Heart Function Tests'}, {'id': 'D003935', 'term': 'Diagnostic Techniques, Cardiovascular'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D004568', 'term': 'Electrodiagnosis'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}, 'patientRegistry': False}, 'statusModule': {'whyStopped': 'Unable to start the study due to changes in personnel.', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2025-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-30', 'studyFirstSubmitDate': '2020-01-06', 'studyFirstSubmitQcDate': '2020-01-06', 'lastUpdatePostDateStruct': {'date': '2025-05-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-01-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'ECG Tracing', 'timeFrame': 'Approximately 30 minutes', 'description': 'ECG tracing for each electrode will be recorded in voltage per unit of time.'}]}, 'oversightModule': {'isUsExport': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Electrocardiogram']}, 'descriptionModule': {'briefSummary': 'This study aims to confirm a scientific concept that superficially placed electrocardiogram (ECG) leads may be compared to one another to help determine positioning. If proven to be effective, this could offer a more non-invasive means of positioning using superficial ECG tracings.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The population of participants include healthy volunteers from the research/administrative/health care staff from the institution.', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Adult volunteers from institution's staff\n* Age \\>18 years\n\nExclusion Criteria:\n\n\\- Existing heart conditions"}, 'identificationModule': {'nctId': 'NCT04221958', 'briefTitle': 'Surface ECG Mapping', 'organization': {'class': 'OTHER', 'fullName': 'Stanford University'}, 'officialTitle': 'Surface ECG Mapping in Healthy Adult Volunteers', 'orgStudyIdInfo': {'id': '54619'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Electrocardiogram (ECG) Mapping', 'description': 'Participants will have 10 superficial electrode-patches placed on their chest in two vertical columns of 5 electrode-patches. The channels V1-V5 will be connected to one of the columns. The channel V6 will be connected to each of the electrode-patches in the second column ad recordings will be taken for approximately 2 minutes on each electrode-patch. ECG readings will be recorded.', 'interventionNames': ['Device: Electrocardiogram']}], 'interventions': [{'name': 'Electrocardiogram', 'type': 'DEVICE', 'description': 'An electrocardiogram measures the electrical activity of the heartbeat. This "intervention" will be used on healthy adult volunteers whom are part of the staff at the institution.', 'armGroupLabels': ['Electrocardiogram (ECG) Mapping']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94305', 'city': 'Stanford', 'state': 'California', 'country': 'United States', 'facility': 'Stanford Health Care', 'geoPoint': {'lat': 37.42411, 'lon': -122.16608}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Stanford University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor-Med Ctr Line', 'investigatorFullName': 'Chi-Ho Ban Tsui', 'investigatorAffiliation': 'Stanford University'}}}}