Ignite Creation Date:
2025-12-24 @ 11:36 PM
Ignite Modification Date:
2026-02-24 @ 10:52 AM
Study NCT ID:
NCT02198456
Status:
UNKNOWN
Last Update Posted:
2018-05-23
First Post:
2014-07-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Imaging Control Study, 3D Echo, MR and RHC.
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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 12}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2014-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-05', 'completionDateStruct': {'date': '2019-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-05-22', 'studyFirstSubmitDate': '2014-07-22', 'studyFirstSubmitQcDate': '2014-07-22', 'lastUpdatePostDateStruct': {'date': '2018-05-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-07-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'right ventricular ejection fracture', 'timeFrame': 'month 12 (+/- 7 days)', 'description': 'right-sided heart catheterization'}], 'secondaryOutcomes': [{'measure': 'right atrial pressure', 'timeFrame': '12 month (+/- 7 days)', 'description': 'right-sided heart catheterization'}, {'measure': 'cardiac index (CI)/cardiac output (CO)', 'timeFrame': '12 months (+/- 7 Days)', 'description': 'right-sided heart catheterization'}, {'measure': 'pulmonary vascular resistance', 'timeFrame': '12 months (+/- 7 days)', 'description': 'right-sided heart catheterization'}, {'measure': 'mean pulmonary capillary wedge pressure', 'timeFrame': '12 month (+/-7 days)', 'description': 'right-sided heart catheterization'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['pulmonary arterial hypertension'], 'conditions': ['Pulmonary Arterial Hypertension WHO Group I']}, 'descriptionModule': {'briefSummary': 'The aim of the study is to intensify the follow up of patients with pulmonary arterial hypertension via modern imaging guided methods in due consideration of the possibilities of three-dimensional echocardiography in order to optimize their specific therapy.\n\nThe hypothesis is that the increased use of modern imaging guided tools is essential for the follow up.', 'detailedDescription': 'It is not possible to perform a magnetic resonance imaging in all patients and as a result echocardiography is not only done at screening but also during the follow up. The imaging technologies made a great progress in the last few years and enable a better assessment of the haemodynamic parameters in our days.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'pulmonary arterial hypertension WHO group I', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age \\>17\n* pulmonary arterial hypertension WHO group I who are going to start a therapy with prostanoid\n* written informed consent\n* Prostanoid naive\n* no change of the pulmonary arterial hypertension therapy within 3 weeks of inclusion into the study\n\nExclusion Criteria:\n\n* pregnancy and lactation period\n* Women of childbearing potential who do not use an effective and secure method for birth control\n* severe chronic kidney insufficiency (glomerular filtration rate \\<30), which will remain for more than 3 months\n* liver insufficiency Child C\n* life expectancy shorter than the course of the study (for example because of a malignant disease)'}, 'identificationModule': {'nctId': 'NCT02198456', 'acronym': 'PARIS', 'briefTitle': 'Imaging Control Study, 3D Echo, MR and RHC.', 'organization': {'class': 'OTHER', 'fullName': 'Elisabethinen Hospital'}, 'officialTitle': 'Prostanoid Therapy in Severe Pulmonary Arterial Hypertension - Imaging Control Study, 3D Echo, MR and RHC.', 'orgStudyIdInfo': {'id': 'Protocol PARIS3D'}}, 'armsInterventionsModule': {'armGroups': [{'label': '3D echocardiography'}]}, 'contactsLocationsModule': {'locations': [{'zip': '4020', 'city': 'Linz', 'state': 'Upper Austria', 'status': 'RECRUITING', 'country': 'Austria', 'contacts': [{'name': 'Regina Steringer-Mascherbauer, MD', 'role': 'CONTACT', 'email': 'regina.mascherbauer@elisabethinen.or.at', 'phone': '0043/732/7676', 'phoneExt': '4916'}], 'facility': 'Krankenhaus der Elisabethinen Linz GmbH', 'geoPoint': {'lat': 48.30639, 'lon': 14.28611}}], 'centralContacts': [{'name': 'Regina Steringer-Mascherbauer, MD', 'role': 'CONTACT', 'email': 'regina.mascherbauer@elisabethinen.or.at', 'phone': '0043/732/7676', 'phoneExt': '4916'}, {'name': 'Andrea Ploechl', 'role': 'CONTACT', 'email': 'andrea.ploechl@elisabethinen.or.at', 'phone': '0043/732/7676', 'phoneExt': '4415'}], 'overallOfficials': [{'name': 'Regina Steringer-Mascherbauer, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Krankenhaus der Elisabethinen Linz GmbH'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Regina Steringer-Mascherbauer', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'OA Dr.', 'investigatorFullName': 'Regina Steringer-Mascherbauer', 'investigatorAffiliation': 'Elisabethinen Hospital'}}}}