Ignite Creation Date:
2025-12-25 @ 2:23 AM
Ignite Modification Date:
2026-03-06 @ 9:42 PM
Study NCT ID:
NCT04126434
Status:
UNKNOWN
Last Update Posted:
2021-09-16
First Post:
2019-10-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Intervention of Air Pollution and Acute Coronary Syndrome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D054058', 'term': 'Acute Coronary Syndrome'}], 'ancestors': [{'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008397', 'term': 'Masks'}], 'ancestors': [{'id': 'D058257', 'term': 'Surgical Attire'}, {'id': 'D004865', 'term': 'Equipment and Supplies, Hospital'}, {'id': 'D004864', 'term': 'Equipment and Supplies'}, {'id': 'D011482', 'term': 'Protective Devices'}, {'id': 'D000067393', 'term': 'Personal Protective Equipment'}, {'id': 'D013523', 'term': 'Surgical Equipment'}, {'id': 'D008420', 'term': 'Manufactured Materials'}, {'id': 'D013676', 'term': 'Technology, Industry, and Agriculture'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-04-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-09', 'completionDateStruct': {'date': '2022-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-09-14', 'studyFirstSubmitDate': '2019-10-11', 'studyFirstSubmitQcDate': '2019-10-11', 'lastUpdatePostDateStruct': {'date': '2021-09-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-10-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'vascular function', 'timeFrame': 'six months', 'description': 'Systolic blood pressure and diastolic blood pressure measured by omron HBP-1300'}, {'measure': 'autonomic nervous function', 'timeFrame': 'six months', 'description': 'Twenty four-hour electrocardiograms and heart rate variability'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Acute Coronary Syndrome']}, 'descriptionModule': {'briefSummary': 'To determine the effect of intervention of ambient air pollution on acute coronary syndrome patients.', 'detailedDescription': 'To investgate the effect of wearing facemasks to decreasing levels of exposure to ambient air on acute coronary syndrome patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Non-smoker of any type during past six months and living in a non-smoking household.\n2. A diagnosis of myocardial infarction or unstable angina 7-90 days prior to signed informed consent.\n\nExclusion Criteria:\n\n1. Unstable CV disorders including uncompensated heart failure, refractory angina, uncontrolled arrhythmias, critical valvular heart disease and severe hypertension.\n2. A history of infection with human immunodeficiency virus.\n3. History of malignancy including leukemia and lymphoma AND/OR any severe, life-threatening disease AND/OR history of drug abuse within the last 2 years.\n4. Pregnancy or intent to get pregnant during the study period.'}, 'identificationModule': {'nctId': 'NCT04126434', 'briefTitle': 'Intervention of Air Pollution and Acute Coronary Syndrome', 'organization': {'class': 'OTHER', 'fullName': 'Peking University'}, 'officialTitle': 'Intervention of Air Pollution and Acute Coronary Syndrome', 'orgStudyIdInfo': {'id': 'WeiHuang19'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'SHAM_COMPARATOR', 'label': 'no masking', 'description': 'not wearing facemask', 'interventionNames': ['Device: mask']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'masking', 'description': 'wearing facemask', 'interventionNames': ['Device: mask']}], 'interventions': [{'name': 'mask', 'type': 'DEVICE', 'description': 'facemask', 'armGroupLabels': ['masking', 'no masking']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100191', 'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Wei Huang, PHD', 'role': 'CONTACT', 'email': 'whuang@bjmu.edu.cn', 'phone': '+86-13521966787'}, {'name': 'Wei Huang, PHD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Peking University ,School of Public Health', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Wei Huang, PhD', 'role': 'CONTACT', 'email': 'whuang@bjmu.edu.cn', 'phone': '+86-13521966787'}], 'overallOfficials': [{'name': 'Wei Huang, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Peking University Health Science Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Peking University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'WeiHuang', 'investigatorAffiliation': 'Peking University'}}}}