Ignite Creation Date:
2025-12-25 @ 3:28 AM
Ignite Modification Date:
2025-12-26 @ 2:09 AM
Study NCT ID:
NCT03954405
Status:
RECRUITING
Last Update Posted:
2021-04-13
First Post:
2019-05-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Multi-marker Approach for Risk Assessment in PAH
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': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 500}, 'targetDuration': '5 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-01', 'completionDateStruct': {'date': '2025-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-04-11', 'studyFirstSubmitDate': '2019-05-10', 'studyFirstSubmitQcDate': '2019-05-16', 'lastUpdatePostDateStruct': {'date': '2021-04-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-05-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'survival', 'timeFrame': '5 years', 'description': 'To recruit a cohort of group 1 PAH cases. define the death as the primary outcome'}], 'secondaryOutcomes': [{'measure': 'clinical worsening', 'timeFrame': '5 years', 'description': 'one of the following: death, heart/lung transplantation, atrial septostomy, hospitalization due to worsening of PAH, start of new specific PAH treatment, persistent decrease of \\>15% from baseline in 6MWD (or \\>30% compared with last study-related measurement), persistent worsening of WHO FC'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pulmonary Arterial Hypertension']}, 'descriptionModule': {'briefSummary': 'Prospective registry including incident patients and prevalent patients which pretends to identify clinical characteristics, treatment trends in-hospital and ten years follow-up outcome through major adverse cardiovascular events (MACE) in a China population with well characterized PAH.', 'detailedDescription': 'baseline include: An echocardiogram to assess the size, shape, pumping action and the extent of any damage to the heart.\n\nLung function tests which include blowing measurements to assess gas volumes within the lungs as well as assessment of how the lungs exchange gases.\n\nRight heart catheterisation (RHC) to diagnose PAH Optional Cardiac Magnetic Resonance tests. 6 minute walk distance (6MWD). To measure exercise capacity Electrocardiogram (ECG), a test that measures the electrical activity of the heart Blood tests\n\nMACE include:\n\ndeath heart/lung transplantation atrial septostomy hospitalization due to worsening of PAH start of new specific PAH treatment persistent decrease of \\>15% from baseline in 6MWD (or \\>30% compared with last study-related measurement) persistent worsening of World Health Organization (WHO) Functional Class (FC）'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '1 Year', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'patients with diagnosis of PAH from groups I', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\ndiagnosis of PAH (by RHC)\n\nExclusion Criteria:\n\nRefusal to participate.'}, 'identificationModule': {'nctId': 'NCT03954405', 'acronym': 'MARS', 'briefTitle': 'Multi-marker Approach for Risk Assessment in PAH', 'organization': {'class': 'OTHER', 'fullName': 'Wuhan Asia Heart Hospital'}, 'officialTitle': 'Multi-marker Approach for Risk Assessment in Pulmonary Arterial Hypertension (PAH)', 'orgStudyIdInfo': {'id': '2018LMC-1'}}, 'contactsLocationsModule': {'locations': [{'city': 'Wuhan', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Qiu qiu', 'role': 'CONTACT'}], 'facility': 'Wuhan Asian Heart Hospital', 'geoPoint': {'lat': 30.58333, 'lon': 114.26667}}], 'centralContacts': [{'name': 'Zheng Xusn', 'role': 'CONTACT', 'email': 'soniazheng@outlook.com', 'phone': '+8618627885144'}], 'overallOfficials': [{'name': 'Qiu Qiu', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Wuhan Asian Heart Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Wuhan Asia Heart Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}