Ignite Creation Date:
2025-12-24 @ 10:06 PM
Ignite Modification Date:
2025-12-25 @ 7:43 PM
Study NCT ID:
NCT04427735
Status:
UNKNOWN
Last Update Posted:
2020-06-11
First Post:
2020-06-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effect of Covid-19 Epidemic on Primary PCI in Patients With STEMI
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000072657', 'term': 'ST Elevation Myocardial Infarction'}, {'id': 'D000086382', 'term': 'COVID-19'}], 'ancestors': [{'id': 'D009203', 'term': 'Myocardial Infarction'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D007238', 'term': 'Infarction'}, {'id': 'D007511', 'term': 'Ischemia'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009336', 'term': 'Necrosis'}, {'id': 'D011024', 'term': 'Pneumonia, Viral'}, {'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D018352', 'term': 'Coronavirus Infections'}, {'id': 'D003333', 'term': 'Coronaviridae Infections'}, {'id': 'D030341', 'term': 'Nidovirales Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-01-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-06', 'completionDateStruct': {'date': '2021-07-24', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-06-10', 'studyFirstSubmitDate': '2020-06-09', 'studyFirstSubmitQcDate': '2020-06-10', 'lastUpdatePostDateStruct': {'date': '2020-06-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-06-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-07-24', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'MACE (major adverse cardiovascular events)', 'timeFrame': '1 year', 'description': 'cardiovascular death, re-infarction, malignant arrhythmia,heart failure, revascularization, and stroke'}, {'measure': 'all-cause death', 'timeFrame': '1 year', 'description': 'death caused by all reason'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['covid-19', 'STEMI', 'primary PCI'], 'conditions': ['STEMI']}, 'referencesModule': {'references': [{'pmid': '34999563', 'type': 'DERIVED', 'citation': 'Gong X, Zhou L, Dong T, Ding X, Zhao H, Chen H, Li H. Impact of COVID-19 pandemic on STEMI undergoing primary PCI treatment in Beijing, China. Am J Emerg Med. 2022 Mar;53:68-72. doi: 10.1016/j.ajem.2021.11.034. Epub 2021 Nov 24.'}]}, 'descriptionModule': {'briefSummary': "The epidemic of covid-19 has spread all over the world and has a great impact on people's health and life. It is necessary to study the treatment of STEMI patients in the real world under the influence of the epidemic,which provide effective suggestions and strategies for emergency and severe treatment.", 'detailedDescription': "The epidemic of covid-19 has spread all over the world and has a great impact on people's health and life. The patients' prognosis is poor because the epidemic situation runs on medical resources, delays the diagnosis and treatment of other diseases such as cardiovascular diseases, and the patients' willingness to see a doctor is reduced. In particular, the delay in the treatment of STEMI, which needs PCI treatment, will cause more damage to the patients. It is necessary to study the treatment of STEMI patients in the real world under the influence of the epidemic. In this study, STEMI patients who experienced emergency PCI treatment after the covid-19 outbreak in 2020 were included, and compared with the data of the same period in 2019,we will analyze the pre hospital treatment time, vascular opening time,and the major cardiovascular adverse events, which provide effective suggestions and strategies for emergency and severe treatment."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'patients with definite diagnosis of acute ST segment elevation myocardial infarction and emergency PCI intervention', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Continuous inclusion of patients with definite diagnosis of acute ST segment elevation myocardial infarction and emergency PCI intervention.\n\nExclusion Criteria:\n\n* Febrile patients, patients with severe infection,\n* ST segment elevation myocardial infarction during hospitalization,\n* Patients who could not cooperate with each other.'}, 'identificationModule': {'nctId': 'NCT04427735', 'briefTitle': 'Effect of Covid-19 Epidemic on Primary PCI in Patients With STEMI', 'organization': {'class': 'OTHER', 'fullName': 'Beijing Friendship Hospital'}, 'officialTitle': 'Effect of Covid-19 Epidemic on Primary PCI and Prognosis in Patients With Acute STEMI', 'orgStudyIdInfo': {'id': 'BFH-COVID-19 and Primary PCI'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'before COVID-19', 'description': 'Patients with myocardial infarction from January 24, 2019 to June 24, 2019'}, {'label': 'after COVID-19', 'description': 'Patients with myocardial infarction from January 24, 2020 to June 24, 2020'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Beijing', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Hongwei Li', 'role': 'CONTACT', 'email': 'lhw19656@sina.com', 'phone': '0086 10 63139780'}, {'name': 'Xuhe Gong', 'role': 'CONTACT', 'email': 'gongxuhe123@126.com', 'phone': '0086 10 63139780'}], 'facility': 'Beijing Friendship Hospital, Capital Medical University', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Hongwei Li, doctor', 'role': 'CONTACT', 'email': 'lhw19656@sina.com', 'phone': '0086 10 63139780'}], 'overallOfficials': [{'name': 'Hongwei Li', 'role': 'STUDY_CHAIR', 'affiliation': 'Beijing Friendship Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Beijing Friendship Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'professor', 'investigatorFullName': 'Hongwei Li, MD', 'investigatorAffiliation': 'Beijing Friendship Hospital'}}}}