Ignite Creation Date:
2025-12-24 @ 3:22 PM
Ignite Modification Date:
2025-12-25 @ 1:40 PM
Study NCT ID:
NCT01717092
Status:
UNKNOWN
Last Update Posted:
2014-02-27
First Post:
2012-10-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Epidemiological Study of Chronic Thromboembolic Pulmonary Hypertension in China
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 400}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2012-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-02', 'completionDateStruct': {'date': '2015-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2014-02-26', 'studyFirstSubmitDate': '2012-10-26', 'studyFirstSubmitQcDate': '2012-10-26', 'lastUpdatePostDateStruct': {'date': '2014-02-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-10-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The cumulative incidence of symptomatic CTEPH', 'timeFrame': '2 years'}], 'secondaryOutcomes': [{'measure': 'Risk factors for Recurrent VTE and CTEPH', 'timeFrame': '2 years'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['To Assess the Long-term Risk for Adverse Events After PE.']}, 'descriptionModule': {'briefSummary': 'Chronic thromboembolic pulmonary hypertension (CTPH) is associated with considerable morbidity and mortality. Its incidence after pulmonary embolism and associated risk factors are not well documented in Chinese population. We conducted a prospective, long-term, follow-up study to assess the incidence of symptomatic CTPH in consecutive patients with an acute episode of pulmonary embolism but without prior venous thromboembolism. Patients with unexplained persistent dyspnea during follow-up underwent transthoracic echocardiography and, if supportive findings were present, ventilation-perfusion lung scanning and pulmonary angiography. CTPH was considered to be present if systolic and mean pulmonary-artery pressures exceeded 40 mm Hg and 25 mm Hg, respectively; pulmonary-capillary wedge pressure was normal; and there was angiographic evidence of disease.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Consecutive patients with an acute episode of pulmonary embolism but without prior venous thromboembolism.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with an episode of acute symptomatic pulmonary embolism without prior pulmonary embolism or venous thrombosis\n\nExclusion Criteria:\n\n* Have other diseases (e.g., systemic sclerosis or severe emphysema) that could have caused nonthromboembolic pulmonary hypertension,\n* Have preexisting exertional dyspnea,\n* Geographically inaccessible for follow-up,\n* Decline to participate in the study.'}, 'identificationModule': {'nctId': 'NCT01717092', 'briefTitle': 'Epidemiological Study of Chronic Thromboembolic Pulmonary Hypertension in China', 'organization': {'class': 'OTHER', 'fullName': 'Air Force Military Medical University, China'}, 'orgStudyIdInfo': {'id': 'XJ-CTPH20121026'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Consecutive patients with acute PE'}]}, 'contactsLocationsModule': {'locations': [{'zip': '710032', 'city': "Xi'an", 'state': 'Shaanxi', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Yonghong Xie, MD', 'role': 'CONTACT', 'email': 'xieyh65@yahoo.com.cn', 'phone': '+86-29-84777725'}], 'facility': 'Tangdu hospital', 'geoPoint': {'lat': 34.25833, 'lon': 108.92861}}, {'zip': '710032', 'city': "Xi'an", 'state': 'Shaanxi', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Yongping Yu, MD', 'role': 'CONTACT', 'email': 'yuyongping_6100@163.com', 'phone': '+86-29-84771132'}, {'name': 'Yongping Yu, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Xinpeng Han, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Xijing hospital', 'geoPoint': {'lat': 34.25833, 'lon': 108.92861}}], 'centralContacts': [{'name': 'Shengqing Li, MD, PhD', 'role': 'CONTACT', 'email': 'shengqingli@gmail.com', 'phone': '+86-29-84771132'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Air Force Military Medical University, China', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, PhD, Associate Chief Physician, Associate Professor', 'investigatorFullName': 'Shengqing Li', 'investigatorAffiliation': 'Air Force Military Medical University, China'}}}}