Ignite Creation Date:
2025-12-24 @ 5:04 PM
Ignite Modification Date:
2026-01-15 @ 5:46 PM
Study NCT ID:
NCT02001350
Status:
COMPLETED
Last Update Posted:
2016-10-17
First Post:
2013-11-22
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Carotid Ultrasound Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D019220', 'term': 'High-Energy Shock Waves'}], 'ancestors': [{'id': 'D000069453', 'term': 'Ultrasonic Waves'}, {'id': 'D013016', 'term': 'Sound'}, {'id': 'D011840', 'term': 'Radiation, Nonionizing'}, {'id': 'D011827', 'term': 'Radiation'}, {'id': 'D055585', 'term': 'Physical Phenomena'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 23}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-10', 'completionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-10-14', 'studyFirstSubmitDate': '2013-11-22', 'studyFirstSubmitQcDate': '2013-11-27', 'lastUpdatePostDateStruct': {'date': '2016-10-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-12-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Specific location of carotid plaque at the bifurcation', 'timeFrame': 'Baseline'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Resistant Hypertension']}, 'descriptionModule': {'briefSummary': "To use carotid ultrasound to screen 20-30 patients with longstanding or resistant hypertension for carotid atherosclerotic disease and bifurcation anatomy. This will establish a screening protocol for Cibiem's eventual endovascular carotid body modulation trial and will give insight into the prevalence and specific location of carotid plaque at the bifurcation in this patient population."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': '30 patients with longstanding or resistant hypertension', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18-75 years old\n* Uncontrolled hypertension on 3 or more medications or longstanding controlled hypertension on 4 or more medications.\n\nExclusion Criteria:\n\n* Previous stroke\n* Carotid endarterectomy or carotid stent procedure\n* \\>50% stenosis anywhere in carotid arteries'}, 'identificationModule': {'nctId': 'NCT02001350', 'briefTitle': 'Carotid Ultrasound Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'Noblewell'}, 'officialTitle': 'Carotid Ultrasound Study', 'orgStudyIdInfo': {'id': 'CIB-USG.GDA.PL'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Resistant hypertension', 'interventionNames': ['Other: Ultrasonography']}], 'interventions': [{'name': 'Ultrasonography', 'type': 'OTHER', 'armGroupLabels': ['Resistant hypertension']}]}, 'contactsLocationsModule': {'locations': [{'zip': '80-952', 'city': 'Gdansk', 'country': 'Poland', 'facility': 'Department of Hypertension and Diabetology, Medical University of Gdansk', 'geoPoint': {'lat': 54.35227, 'lon': 18.64912}}], 'overallOfficials': [{'name': 'Paul A. Sobotka, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Cibiem, Inc.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Noblewell', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Cibiem, Inc.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}