Ignite Creation Date:
2025-12-24 @ 10:20 PM
Ignite Modification Date:
2026-01-02 @ 12:04 AM
Study NCT ID:
NCT03140735
Status:
WITHDRAWN
Last Update Posted:
2023-07-20
First Post:
2017-04-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Interest of Pulse Wave Velocity Measurement as a Predictor of Severity of Aortic Stenosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001024', 'term': 'Aortic Valve Stenosis'}], 'ancestors': [{'id': 'D000082862', 'term': 'Aortic Valve Disease'}, {'id': 'D006349', 'term': 'Heart Valve Diseases'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014694', 'term': 'Ventricular Outflow Obstruction'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D035061', 'term': 'Control Groups'}], 'ancestors': [{'id': 'D015340', 'term': 'Epidemiologic Research Design'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D012107', 'term': 'Research Design'}, {'id': 'D008722', 'term': 'Methods'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'no participants enrolled', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2017-07-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-07', 'completionDateStruct': {'date': '2023-06-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-07-18', 'studyFirstSubmitDate': '2017-04-14', 'studyFirstSubmitQcDate': '2017-05-02', 'lastUpdatePostDateStruct': {'date': '2023-07-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-05-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-06-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Analysis of echocardiographic measurements of possible differences between average VOP and Sao i in terms of RA severities', 'timeFrame': '10 years', 'description': 'Analysis of echocardiographic measurements of possible differences between average VOP and Sao i in terms of RA severities'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pulse Wave', 'Aortic Stenosis']}, 'descriptionModule': {'briefSummary': 'Aortic valve pathology is the third most common cardiovascular disease after coronary artery disease and hypertension, which is responsible for severe morbidity and mortality in elderly patients and requires surgical treatment in its most severe form of progression. The purpose of this study is to find a link between arterial stiffness and degenerative aortic stenosis. If this link is established, arterial stiffness may become a medical therapeutic target in order to delay the evolution of the disease.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients over 18 years of age, without legal protection (guardianship or curatorship),\n* Stable hemodynamic status.\n* Affiliation to a social security scheme\n\nExclusion Criteria:\n\n* Hemodynamically unstable patients: Systolic PA \\<10 cmHg, rapid peripheral pulse and spinning, mottling, obnubilation, oliguria, sweating, coma\n* History of significant valvulopathy other than an aortic stenosis,\n* Pregnancy.\n* Patient under tutelage or curatelle or deprived of public right.'}, 'identificationModule': {'nctId': 'NCT03140735', 'acronym': 'VOPRABIO', 'briefTitle': 'Interest of Pulse Wave Velocity Measurement as a Predictor of Severity of Aortic Stenosis', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire, Amiens'}, 'officialTitle': 'Interest of Pulse Wave Velocity Measurement as a Predictor of Severity of Aortic Stenosis', 'orgStudyIdInfo': {'id': 'PI2016_843_0035'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Control group of 150 heart disease-free individuals', 'interventionNames': ['Other: Control group without heart disease']}, {'type': 'OTHER', 'label': 'Patients with aortic sclerosis', 'interventionNames': ['Other: Study the relationship between the arterial rigidity of large vessels and the presence and severity of degenerative aortic constriction']}, {'type': 'OTHER', 'label': 'Patients with moderate aortic stenting (RA)', 'interventionNames': ['Other: Study the relationship between the arterial rigidity of large vessels and the presence and severity of degenerative aortic constriction']}, {'type': 'OTHER', 'label': 'Patients with Serious Aortic Retention', 'interventionNames': ['Other: Study the relationship between the arterial rigidity of large vessels and the presence and severity of degenerative aortic constriction']}], 'interventions': [{'name': 'Study the relationship between the arterial rigidity of large vessels and the presence and severity of degenerative aortic constriction', 'type': 'OTHER', 'description': 'Study the relationship between the arterial rigidity of large vessels and the presence and severity of degenerative aortic constriction', 'armGroupLabels': ['Patients with Serious Aortic Retention', 'Patients with aortic sclerosis', 'Patients with moderate aortic stenting (RA)']}, {'name': 'Control group without heart disease', 'type': 'OTHER', 'description': 'Control group without heart disease', 'armGroupLabels': ['Control group of 150 heart disease-free individuals']}]}, 'contactsLocationsModule': {'locations': [{'zip': '80054', 'city': 'Amiens', 'state': 'Picardie', 'country': 'France', 'facility': 'CHU Amiens Picardie', 'geoPoint': {'lat': 49.9, 'lon': 2.3}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire, Amiens', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}