Ignite Creation Date:
2025-12-24 @ 5:25 PM
Ignite Modification Date:
2026-03-15 @ 1:40 AM
Study NCT ID:
NCT02444650
Status:
COMPLETED
Last Update Posted:
2015-07-10
First Post:
2015-04-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Measurement of Pulse Wave Velocity
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 32}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-07', 'completionDateStruct': {'date': '2015-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-07-09', 'studyFirstSubmitDate': '2015-04-29', 'studyFirstSubmitQcDate': '2015-05-11', 'lastUpdatePostDateStruct': {'date': '2015-07-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-05-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Optically based pulse wave velocity measurement correlation to the tonometry measure.', 'timeFrame': '2 hours'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Correlation', 'pulse wave velocity measurement', 'tonometry'], 'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'Optically-based data will be compared to tonometry to determine correlation of pulse wave velocity measurement.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Healthy normotensive and hypertensive subjects.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Between the ages of18-25 and 65-90 will be studied.\n* Normotensive and hypertensive subjects\n* Willing to provide informed consent\n\nExclusion Criteria:\n\n* has finger deformities or amputations that will prohibit proper sensor placement\n* pregnant or actively trying to get pregnant\n* Cardiogreen or other intravascular/tissue dyes less than 5 hours prior to the study.'}, 'identificationModule': {'nctId': 'NCT02444650', 'briefTitle': 'Measurement of Pulse Wave Velocity', 'organization': {'class': 'INDUSTRY', 'fullName': 'Nonin Medical, Inc'}, 'officialTitle': 'Photoplethysmogram Measurement of Pulse Wave Velocity', 'orgStudyIdInfo': {'id': 'QATP2804'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Pulse wave velocity measurement Photoplethysmogram', 'type': 'DEVICE', 'description': 'Correlation of pulse wave velocity measurement.'}, {'name': 'tonometer', 'type': 'DEVICE'}]}, 'contactsLocationsModule': {'locations': [{'zip': '55902', 'city': 'Rochester', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Mayo Clinic', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}], 'overallOfficials': [{'name': 'Timothy Curry, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mayo Clinic'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nonin Medical, Inc', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Mayo Clinic', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}