Ignite Creation Date:
2025-12-25 @ 3:31 AM
Ignite Modification Date:
2025-12-26 @ 2:13 AM
Study NCT ID:
NCT05273905
Status:
UNKNOWN
Last Update Posted:
2022-03-24
First Post:
2022-03-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Augmented Velocity Index of Intra-abdominal, Carotid and Retinal Arteries
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 350}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2022-05', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-03', 'completionDateStruct': {'date': '2025-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-03-09', 'studyFirstSubmitDate': '2022-03-01', 'studyFirstSubmitQcDate': '2022-03-01', 'lastUpdatePostDateStruct': {'date': '2022-03-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-03-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Augmented Velocity Index (Avi)', 'timeFrame': 'Aug 2022 - May 2024', 'description': 'Avi of carotid, renal, hepatic and retinal arteries as recorded from the Doppler ultrasound waveforms of those arteries'}], 'secondaryOutcomes': [{'measure': 'Arterial wall thickness, liver stiffness and fatty liver status', 'timeFrame': 'Aug 2022 - May 2024', 'description': 'Intima-media thickness of carotid artery is measured in gray scale ultrasound images; Liver stiffness is assessed by shear wave elastography of ultrasound technique; Fatty liver status is determined by the attenuation imaging of ultrasound'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Arterial Stiffness']}, 'descriptionModule': {'briefSummary': 'Background:\n\nAugmented Velocity Index (Avi) is a new Doppler index which can potentially be used to assess arterial stiffness. The Avi of common carotid artery is found to be associated with arterial stiffness and have initial correlation with cardiovascular risk factors. Avi can be used in any vessels (superficial or deep vessels) where arterial Doppler waveforms can be obtained.\n\nAims:\n\nThe aims of this study are to investigate the associations of Avi of hepatic artery, renal artery, central retinal artery and internal carotid artery with arterial stiffness and cardiovascular risk factors in a group of apparently normal subjects.\n\nMethods:\n\nRecruit 350 subjects with no known medical illness or drug treatment for ultrasound examinations and blood tests. In ultrasound examination, the Avi of carotid arteries, hepatic arteries, renal arteries and retinal arteries are recorded. The carotid-femoral pulse wave velocity is also calculated for the assessment of central aortic stiffness.\n\nOther important correlates of arterial stiffness including carotid intima-media thickness, fatty liver status, liver stiffness and abdominal fat thickness are assessed in the ultrasound examination.\n\nThe clinical and laboratory examinations include anthropometric indexes, plasma glucose level, lipid profile, renal function tests, liver function test, urinary albumin creatinine ratio, blood pressure measurement.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Apparently healthy volunteers', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Apparently healthy volunteers\n\nExclusion Criteria:\n\n* Subjects with known medical illnesses including cancer, stroke, cardiovascular disease, diabetes, hypertension, dyslipidaemia, peripheral vascular disease, gout, systemic lupus erythematosus, psoriasis, rheumatoid arthritis and thyrotoxicosis.\n* Subjects with long term drug use'}, 'identificationModule': {'nctId': 'NCT05273905', 'briefTitle': 'Augmented Velocity Index of Intra-abdominal, Carotid and Retinal Arteries', 'organization': {'class': 'OTHER', 'fullName': 'Chinese University of Hong Kong'}, 'officialTitle': 'Augmented Velocity Index of Intra-abdominal, Carotid and Retinal Arteries: In Relation to Arterial Stiffness and Cardiovascular Risk Factors.', 'orgStudyIdInfo': {'id': '2022.3.1'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Ultrasound derived Avi', 'type': 'DIAGNOSTIC_TEST', 'description': 'Assess the Avi of carotid arteries, hepatic arteries, renal arteries and central retinal arteries.'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chinese University of Hong Kong', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Adjunct Associate Professor', 'investigatorFullName': 'Liu Kin Hung', 'investigatorAffiliation': 'Chinese University of Hong Kong'}}}}