Ignite Creation Date:
2025-12-24 @ 3:15 PM
Ignite Modification Date:
2026-01-04 @ 11:36 PM
Study NCT ID:
NCT05360992
Status:
COMPLETED
Last Update Posted:
2022-05-04
First Post:
2022-04-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pulmonary Embolism: Mechanism and Therapeutic Innovation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011655', 'term': 'Pulmonary Embolism'}], 'ancestors': [{'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D004617', 'term': 'Embolism'}, {'id': 'D016769', 'term': 'Embolism and Thrombosis'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'storage at -80℃'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1200}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-04', 'completionDateStruct': {'date': '2021-10-13', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-04-29', 'studyFirstSubmitDate': '2022-04-27', 'studyFirstSubmitQcDate': '2022-04-29', 'lastUpdatePostDateStruct': {'date': '2022-05-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-05-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-10-13', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Recurrent Incidence of Patients', 'timeFrame': 'through study completion, an average of 1 year.', 'description': 'Recurrent PE was measured by computed tomography pulmonary angiography (CTPA) or ventilation/perfusion (V/Q) lung scans. Recurrent deep venous thrombosis was measured by lower extremity Doppler ultrasound.'}, {'measure': 'Bleeding Rate of Patients', 'timeFrame': 'through study completion, an average of 1 year.', 'description': 'Events were recored by follow-up.'}, {'measure': 'Survival Rate of Patients', 'timeFrame': 'through study completion, an average of 1 year.', 'description': 'Events were recored by follow-up.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['pulmonary embolism', 'chronic thromboembolic pulmonary hypertension', 'mechanism', 'therapy', 'outcome'], 'conditions': ['Pulmonary Embolism']}, 'referencesModule': {'references': [{'pmid': '36135453', 'type': 'DERIVED', 'citation': 'Wu Y, Hu S, Yan XX, Peng FH, Tan JS, Guo TT, Gao X, Hua L. Chronic Thromboembolic Pulmonary Hypertension in Females: Clinical Features and Survival. J Cardiovasc Dev Dis. 2022 Sep 16;9(9):308. doi: 10.3390/jcdd9090308.'}]}, 'descriptionModule': {'briefSummary': 'To explore the pathogenesis, therapy and outcome of pulmonary embolism (PE) and chronic thromboembolic pulmonary hypertension (CTEPH).', 'detailedDescription': 'The study recruited consecutive outpatients or hospitalized patients diagnosed with pulmonary embolism (PE cohort) and chronic thromboembolic pulmonary hypertension (CTEPH cohort). The follow-up of all patients was performed annually by phone or outpatient visit. The main outcomes were bleeding, recurrent events, and survival. The objective of the study was to explore the pathogenesis, therapy and outcome of PE and CTEPH.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'The consecutive hospitalized patients or outpatients diagnosed with PE or CTEPH.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All hospitalized patients or outpatients diagnosed with PE or CTEPH;\n* Age ≥18.\n\nExclusion Criteria:\n\n* Refused informed consents.'}, 'identificationModule': {'nctId': 'NCT05360992', 'briefTitle': 'Pulmonary Embolism: Mechanism and Therapeutic Innovation', 'organization': {'class': 'OTHER_GOV', 'fullName': 'China National Center for Cardiovascular Diseases'}, 'officialTitle': 'Pulmonary Embolism: Mechanism and Therapeutic Innovation', 'orgStudyIdInfo': {'id': '2017-I2M-3-003'}}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Lu Hua, Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Chinese Academy of Medical Sciences, Fuwai Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'China National Center for Cardiovascular Diseases', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director, Center for Respiratory and Pulmonary Vascular Diseases，Principal Investigator, Clinical Professor', 'investigatorFullName': 'Lu Hua', 'investigatorAffiliation': 'China National Center for Cardiovascular Diseases'}}}}