Ignite Creation Date:
2025-12-25 @ 4:33 AM
Ignite Modification Date:
2025-12-26 @ 3:35 AM
Study NCT ID:
NCT06272318
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-05-13
First Post:
2024-02-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Vital Signs Blood Pressure Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D006973', 'term': 'Hypertension'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C075430', 'term': 'serglycin'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-09-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2026-09-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-12', 'studyFirstSubmitDate': '2024-02-06', 'studyFirstSubmitQcDate': '2024-02-14', 'lastUpdatePostDateStruct': {'date': '2025-05-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-02-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-09-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Collection of Subject Name (optional)', 'timeFrame': 'Less than 1 minute'}, {'measure': 'Collection of Subject Height', 'timeFrame': 'Less than 1 minute', 'description': 'Height in meters'}, {'measure': 'Collection of Subject Weight', 'timeFrame': 'Less than 1 minute', 'description': 'Weight in kilograms'}, {'measure': 'Collection of Subject Age', 'timeFrame': 'Less than 1 minute', 'description': 'Age in years'}, {'measure': 'Collection of Subject Medical Comorbidities', 'timeFrame': '1 minute'}, {'measure': 'Systolic and Diastolic Blood Pressure Measurement', 'timeFrame': '1-2 minutes', 'description': 'Using blood pressure cuff; measured three times to find the initial, interim, and final blood pressure'}, {'measure': 'Collection of ECG Waveforms', 'timeFrame': '5 minutes', 'description': 'Using an electrocardiogram (ECG) to measure heart rhythm'}, {'measure': 'Collection of PPG Waveforms', 'timeFrame': '5 minutes', 'description': 'Using a photoplethysmography (PPG) to monitor heart rate'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cardiovascular Diseases', 'Hypertension', 'Blood Pressure']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is collect subject vitals with a blood pressure cuff, electrocardiogram (ECG), and photoplethysmogram (PPG). This data can then be used to develop a reliable, accurate, noninvasive, and continuous blood pressure monitoring device.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '64 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Participants with a range of health conditions are needed for this study, including those with cardiac or blood pressure issues, as well as individuals who are considered healthy.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age \\>17 and \\<65 years\n* BMI \\>20 and \\<35\n\nExclusion Criteria:\n\n* Age \\<18 or \\>64\n* BMI \\<20 or \\>35\n* Pregnancy'}, 'identificationModule': {'nctId': 'NCT06272318', 'briefTitle': 'Vital Signs Blood Pressure Trial', 'organization': {'class': 'OTHER', 'fullName': 'Stanford University'}, 'officialTitle': 'Vital Signs Blood Pressure Trial', 'orgStudyIdInfo': {'id': '74131'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Blood Pressure Cuff, EKG, PPG', 'type': 'OTHER', 'description': 'A blood pressure cuff, an EKG, and a PPG will be utilized to collect subject vitals.'}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'David Drover, MD', 'role': 'CONTACT', 'email': 'ddrover@stanford.edu', 'phone': '650-714-0316'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Stanford University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'David R. Drover', 'investigatorAffiliation': 'Stanford University'}}}}