Ignite Creation Date:
2025-12-24 @ 4:25 PM
Ignite Modification Date:
2026-02-20 @ 6:35 PM
Study NCT ID:
NCT03616366
Status:
UNKNOWN
Last Update Posted:
2018-08-06
First Post:
2018-01-04
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Mechanism and Prognosis of Pulmonary Circulation Dysfunction
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'serum and blood cells'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1000}, 'targetDuration': '3 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-08-10', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-07', 'completionDateStruct': {'date': '2020-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-07-27', 'studyFirstSubmitDate': '2018-01-04', 'studyFirstSubmitQcDate': '2018-07-27', 'lastUpdatePostDateStruct': {'date': '2018-08-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-08-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'All cause death', 'timeFrame': '6 months', 'description': 'death'}], 'secondaryOutcomes': [{'measure': 'Venous thromboembolism (VTE) recurrence', 'timeFrame': '6months', 'description': 'VTE recurrence detected by echocardiography or CTPA scan'}, {'measure': 'chronic thromboembolism pulmonary hypertension(CTEPH)', 'timeFrame': '6 months', 'description': 'newly developed CTEPH detected by pulmonary angiography'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['VTE', 'SNP', 'biomarkers'], 'conditions': ['VTE']}, 'descriptionModule': {'briefSummary': "Venous thromboembolism (VTE) is a condition which influenced by both environmental and genetic factors. This study is going to explore new significant Single nucleotide polymorphisms (SNPs) associated with VTE by Genome-Wide Association Studies (GWAS) and bioinformatics analysis. Transcriptomics and cytokine antibody array are also used to find new biomarkers of VTE's early diagnosis, severity and prognosis."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '14 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Acute VTE patients and healthy controls', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Chinese Han population older than 14 years old\n* Acute VTE patients diagnosed in 1 month\n* With informed consent\n\nExclusion Criteria:\n\n* Patients with psychosis\n* Patients with contraindications for computed tomographic pulmonary angiography (CTPA)\n* Chronic VTE\n* Recurrence of chronic VTE'}, 'identificationModule': {'nctId': 'NCT03616366', 'briefTitle': 'The Mechanism and Prognosis of Pulmonary Circulation Dysfunction', 'organization': {'class': 'OTHER', 'fullName': 'Chinese Academy of Medical Sciences, Fuwai Hospital'}, 'officialTitle': 'The Mechanism and Prognosis of Pulmonary Circulation Dysfunction in Pulmonary Injury and Recovery', 'orgStudyIdInfo': {'id': '2017-I2M-1-009'}}, 'contactsLocationsModule': {'locations': [{'zip': '100037', 'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Jianguo He, MD', 'role': 'CONTACT', 'email': 'hejianguofw@163.com', 'phone': '86 01088398060'}, {'name': 'Jianguo He, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Cardiovascular Institute and Fu Wai Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Jianguo He, MD', 'role': 'CONTACT', 'email': 'hejianguofw@163.com', 'phone': '80-10-88398060'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chinese Academy of Medical Sciences, Fuwai Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Chief of Pulmonary Vascular Disease Center', 'investigatorFullName': 'Jianguo He', 'investigatorAffiliation': 'Chinese Academy of Medical Sciences, Fuwai Hospital'}}}}