Ignite Creation Date:
2025-12-25 @ 1:40 AM
Ignite Modification Date:
2025-12-26 @ 12:19 AM
Study NCT ID:
NCT04419194
Status:
COMPLETED
Last Update Posted:
2020-06-05
First Post:
2020-06-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Climatic Factors on the Seasonal Fluctuation of Pulmonary Embolism
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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 10000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-07-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-05', 'completionDateStruct': {'date': '2019-07-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-06-04', 'studyFirstSubmitDate': '2020-06-04', 'studyFirstSubmitQcDate': '2020-06-04', 'lastUpdatePostDateStruct': {'date': '2020-06-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-06-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-07-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of pulmonary embolism', 'timeFrame': 'From July 31, 2014 to July 31, 2019', 'description': 'Daily counts of hospital admissions for primary diagnoses of pulmonary embolism among different demographic groups were used to estimate the associations between climatic factors and morbidity.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Pulmonary Embolism', 'Climate'], 'conditions': ['Pulmonary Embolism']}, 'descriptionModule': {'briefSummary': 'To estimate the risks of daily hospital admissions for pulmonary embolism associated with short term exposure to climatic factors (temperature, precipitation, air pressure, sunshine duration, relative humidity, wind speed, and ambient fine particulate matter \\[aerodynamic diameter ≤2.5 μm; PM2.5\\]) in China.', 'detailedDescription': 'Hospital admissions for pulmonary embolism were identified based on the primary diagnosis. The central adjudication committee at Peking Union Medical College Hospital (Beijing, China) reviewed all medical and death records and determined the final diagnosis. Two adjudication committee members verified events independently, and discrepancies were resolved by discussion involving additional committee members.For each admission, we extracted data on the date of admission, sex, age, and location of the patient from hospital information system.\n\nAll the data of daily meteorological variables for the same period, including temperature variables (°C) (the min, max and mean temperature), relative humidity (%), air pressure (hPa), precipitation (mm), wind speed (m/s) and sunshine duration (h), were collected from the China Meteorological Data Sharing Service System (http://www.escience.gov.cn/metdata/page/index.html). The data on PM2.5 levels in each city was collected from the National Air Pollution Monitoring System.\n\nAn overdispersed generalised additive model was used to estimate associations between climatic factors and pulmonary embolism admissions. A distributed lag non-linear model (DLNM) was employed to examine their lagged effects.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients diagnosed as pulmonary embolism who meet the inclusion criteria above.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Males and females.\n* With a primary diagnosis of pulmonary embolism based on clinical symptoms, with or without radiologic features.\n\nExclusion Criteria:\n\n* Lack of important data.'}, 'identificationModule': {'nctId': 'NCT04419194', 'briefTitle': 'Effect of Climatic Factors on the Seasonal Fluctuation of Pulmonary Embolism', 'organization': {'class': 'OTHER', 'fullName': 'Peking Union Medical College Hospital'}, 'officialTitle': 'Association Between Climatic Factors and Hospital Admissions for Pulmonary Embolism: Time Series Study in China Between Years 2014 to 2019.', 'orgStudyIdInfo': {'id': 'PUMCH-PE-Climatic factors'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Observation', 'description': 'Observation'}]}, 'contactsLocationsModule': {'locations': [{'zip': '100730', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': 'Peking Union Medical College Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'overallOfficials': [{'name': 'Shi Juhong, M.D', 'role': 'STUDY_CHAIR', 'affiliation': 'Peking Union Medical College Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Peking Union Medical College Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}