Ignite Creation Date:
2026-03-26 @ 3:21 PM
Ignite Modification Date:
2026-03-29 @ 11:22 PM
Study NCT ID:
NCT03184727
Status:
UNKNOWN
Last Update Posted:
2017-06-14
First Post:
2017-06-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pulmonary Vasculature and Right Heart Dysfunction in Chronic Obstructive Pulmonay Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D029424', 'term': 'Pulmonary Disease, Chronic Obstructive'}, {'id': 'D018497', 'term': 'Ventricular Dysfunction, Right'}], 'ancestors': [{'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D018754', 'term': 'Ventricular Dysfunction'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'serum and blood cells'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 600}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-06-15', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-06', 'completionDateStruct': {'date': '2020-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-06-13', 'studyFirstSubmitDate': '2017-06-08', 'studyFirstSubmitQcDate': '2017-06-10', 'lastUpdatePostDateStruct': {'date': '2017-06-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-06-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'All-cause mortality', 'timeFrame': '3 years', 'description': 'survival rate in %'}], 'secondaryOutcomes': [{'measure': 'COPD exacerbations', 'timeFrame': '3 year', 'description': 'total times'}, {'measure': 'GOLD degree', 'timeFrame': '3 year', 'description': 'Ⅰ-Ⅳ according to the pulmonary function'}, {'measure': 'NYHA degree', 'timeFrame': '3 year', 'description': 'Ⅰ-Ⅳ according to the symptom'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['COPD', 'Pulmonary Vascular Disorder', 'Right Ventricular Dysfunction']}, 'descriptionModule': {'briefSummary': "The pulmonary vasculopathy and right heart dysfunction in COPD are drawing increasing attention these days. Recent researches show that pulmonary vasculopathy and right heart dysfunction relate to greater severity in COPD. Applying appropriate modalities for early detection of pulmonary vasculopathy and right heart dysfunction is of great importance. What's more, the interaction mechanism between pulmonary vasculature, right heart and COPD still needs to be further studied. The aim of our study is to develop an assessment system of pulmonary vasculopathy and right heart dysfunction in COPD patients and elucidate their impact on COPD course and outcome."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '40 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'stable COPD patients', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* stable COPD patients\n\nExclusion Criteria:\n\n* patents with other respiratory diseases and pulmonary hypertension other than group 3 PH;\n* psychopath, addict or patients not able to coordinate;\n* patients in pregnancy or breastfeeding;\n* patients with limited life expectancy;\n* patients with contraindiction for MRI or PET;\n* patients having cerebrovascular events in 3 months;\n* unstable COPD patients'}, 'identificationModule': {'nctId': 'NCT03184727', 'briefTitle': 'Pulmonary Vasculature and Right Heart Dysfunction in Chronic Obstructive Pulmonay Disease', 'organization': {'class': 'OTHER', 'fullName': 'Chinese Academy of Medical Sciences, Fuwai Hospital'}, 'officialTitle': 'Pulmonary Vasculature and Right Heart Dysfunction in Chronic Obstructive Pulmonay Disease', 'orgStudyIdInfo': {'id': '2016YFC1304405'}}, '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 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'}}}}