Ignite Creation Date:
2025-12-25 @ 2:24 AM
Ignite Modification Date:
2026-03-02 @ 5:52 PM
Study NCT ID:
NCT03105934
Status:
COMPLETED
Last Update Posted:
2018-02-12
First Post:
2017-04-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Repeatability of OCT and IV-US in Pulmonary Arterial Hypertension
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000081029', 'term': 'Pulmonary Arterial Hypertension'}], 'ancestors': [{'id': 'D006976', 'term': 'Hypertension, Pulmonary'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C060424', 'term': 'hydralazine 4-anisaldehyde hydrazone'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-02', 'completionDateStruct': {'date': '2018-01-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-02-09', 'studyFirstSubmitDate': '2017-04-04', 'studyFirstSubmitQcDate': '2017-04-04', 'lastUpdatePostDateStruct': {'date': '2018-02-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-04-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-10-18', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Image measurements', 'timeFrame': '12 months', 'description': 'Repeat acquisitions to be made in the same regions and in locations'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pulmonary Arterial Hypertension']}, 'descriptionModule': {'briefSummary': 'To assess the correlation between pulmonary IV-OCT and pulmonary IV-US measurements and standard PAH clinical measures of disease progression and the relative sensitivity of the techniques to change.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* With confirmed diagnosis of PAH Group 1 according to the ESC/ERS Guidelines\n* With severe disease, defined as Class II- III of the modified WHO functional classes in the ESC/ERS Guidelines\n\nExclusion Criteria:\n\n* That according to investigator criteria cannot participate in the trial'}, 'identificationModule': {'nctId': 'NCT03105934', 'briefTitle': 'Repeatability of OCT and IV-US in Pulmonary Arterial Hypertension', 'organization': {'class': 'OTHER', 'fullName': "Hospital Universitari Vall d'Hebron Research Institute"}, 'officialTitle': 'Repeatability of Optical Coherence Tomography (OCT) and Intravascular Ultrasound (IV-US) in Pulmonary Arterial Hypertension', 'orgStudyIdInfo': {'id': 'IVUS'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Pulmonary Arterial Hypertension', 'description': 'Patients with Pulmonary Arterial Hypertension', 'interventionNames': ['Procedure: Patients with Pulmonary Arterial Hypertension']}], 'interventions': [{'name': 'Patients with Pulmonary Arterial Hypertension', 'type': 'PROCEDURE', 'description': '2 repeated measurement session to enable assessment of technical and medium-term reproducibility of IV-US and IV-OCT.', 'armGroupLabels': ['Pulmonary Arterial Hypertension']}]}, 'contactsLocationsModule': {'locations': [{'zip': '08035', 'city': 'Barcelona', 'country': 'Spain', 'facility': "Hospital Vall d'Hebron", 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}], 'overallOfficials': [{'name': 'Enric Domingo, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Hospital Vall d'Hebron"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Hospital Universitari Vall d'Hebron Research Institute", 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}