Ignite Creation Date:
2025-12-26 @ 10:44 PM
Ignite Modification Date:
2025-12-26 @ 10:44 PM
Study NCT ID:
NCT03821012
Status:
UNKNOWN
Last Update Posted:
2019-01-29
First Post:
2019-01-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
China STEMI Care Project
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000072657', 'term': 'ST Elevation Myocardial Infarction'}], '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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2011-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-01', 'completionDateStruct': {'date': '2021-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-01-28', 'studyFirstSubmitDate': '2019-01-22', 'studyFirstSubmitQcDate': '2019-01-28', 'lastUpdatePostDateStruct': {'date': '2019-01-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-01-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'the total duration of myocardial ischemia', 'timeFrame': '12 hours', 'description': 'Median time from symptom onset to target vessel open in STEMI patients'}, {'measure': 'the reperfusion treatment ratio', 'timeFrame': '12 hours', 'description': 'the ratio of primary PCI plus thrombolysis usage in STEMI patients'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['ST-Elevation Myocardial Infarction']}, 'referencesModule': {'references': [{'pmid': '31320346', 'type': 'DERIVED', 'citation': 'Zhang Y, Yu B, Han Y, Wang J, Yang L, Wan Z, Zhang Z, Chen Y, Fu X, Gao C, Li B, Chen J, Wu M, Ma Y, Zhao X, Chen Y, Yan H, Xiang D, Fang W, Mehta S, Naber CK, Ge J, Huo Y. Protocol of the China ST-segment elevation myocardial infarction (STEMI) Care Project (CSCAP): a 10-year project to improve quality of care by building up a regional STEMI care network. BMJ Open. 2019 Jul 17;9(7):e026362. doi: 10.1136/bmjopen-2018-026362.'}]}, 'descriptionModule': {'briefSummary': 'The China ST-elevation myocardial infarction (STEMI) Care Project (CSCAP) aims to improve the reperfusion treatment rate and shorten the total duration of myocardial ischemia by establishing a regional STEMI treatment network covering the whole-city region, whole-city population, and whole-disease process step by step. The CSCAP is a prospective, multicenter registry involving three phases. A total of 18 provinces, 4 municipalities, and 2 autonomous regions in China were included. Patients with STEMI who met with the third acute myocardial infarction definition and the Chinese STEMI diagnosis and treatment guidelines were enrolled and the estimated number is over 50,000. Phase 1 (CSCAP-1) focused on the in-hospital process optimization of primary percutaneous coronary intervention (PPCI) hospitals. Phase 2 (CSCAP-2) focused on the PPCI hospital-based regional STEMI transfer network, including emergency medical services and non-PPCI hospitals. Phase 3 (CSCAP-3) focused on the whole-city STEMI care network construction by promoting chest pain center accreditation. Systematic data collection, assessment of quality of care, and subsequent improvement were implemented throughout the project to continuously improve the quality of care for patients with STEMI.\n\nCSCAP is the first project that focused on establishing a regional STEMI emergency care network in China to help understand the condition of STEMI care in China extensively. Moreover, its objective was to optimize the quality of STEMI care through in-hospital process optimization (2012-2013), PPCI hospital-based regional STEMI transfer network construction (2015-2018), and construction of the whole-city STEMI care network step by step (2018-2021). However, hospitals were not randomly selected in CSCAP, which might be because of the lack of representatives to some degree. Alternatively, it focused on providing a tailored quality-of-care improvement plan based on the conditions of different regions.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'In CSCAP-1, a total of 4191 patients admitted to hospitals, with symptom onset within 12 h, regardless of whether receiving reperfusion or symptom onset within 12-24 h of needing PPCI, were enrolled consecutively in 53 tertiary hospitals qualified for PPCI in 14 provinces/municipalities/autonomous regions of China in 2012.\n\nIn CSCAP-2, a total of 20,799 patients with STEMI occurrence within 30 days, regardless of reperfusion, were enrolled consecutively from PPCI hospitals 3 times at a 6-month interval in 244 PCI hospitals with hundreds of adjunct non-PCI hospitals from 24 provinces/municipalities/autonomous regions from 2015 to 2018.\n\nIn CSCAP-3, a total of 30 hospitalized patients with symptom onset within 30 days were enrolled consecutively from each hospital every 3 months. Patients with STEMI were enrolled consecutively from the whole network units, including both PCI and non-PCI hospitals in 7 cities in China.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* STEMI patients\n\nExclusion Criteria:\n\n* None'}, 'identificationModule': {'nctId': 'NCT03821012', 'briefTitle': 'China STEMI Care Project', 'organization': {'class': 'OTHER', 'fullName': 'Peking University First Hospital'}, 'officialTitle': 'China STEMI Care Project: a 10-year Project to Improve Quality of Care by Building up the a Regional STEMI Care Network', 'orgStudyIdInfo': {'id': 'CSCAP'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'CSCAP-1', 'description': 'STEMI with symptom onset within 12 h regardless of whether receiving reperfusion or symptom onset within 12-24 h of needing PPCI', 'interventionNames': ['Other: in-hospital process optimization']}, {'label': 'CSCAP-2', 'description': 'STEMI patients with symptom onset within 30 days', 'interventionNames': ['Other: PPCI hospital-based regional STEMI transfer network construction']}, {'label': 'CSCAP-3', 'description': 'STEMI patients with symptom onset within 30 days', 'interventionNames': ['Other: the whole-city STEMI care network construction']}], 'interventions': [{'name': 'in-hospital process optimization', 'type': 'OTHER', 'armGroupLabels': ['CSCAP-1']}, {'name': 'PPCI hospital-based regional STEMI transfer network construction', 'type': 'OTHER', 'armGroupLabels': ['CSCAP-2']}, {'name': 'the whole-city STEMI care network construction', 'type': 'OTHER', 'armGroupLabels': ['CSCAP-3']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100034', 'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Yan Zhang, MD', 'role': 'CONTACT'}], 'facility': 'Peking University First Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Yan Zhang, MD', 'role': 'CONTACT', 'email': 'drzhy1108@163.com', 'phone': '8610-83575728'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Peking University First Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director, Department of Cardiology', 'investigatorFullName': 'Yong Huo', 'investigatorAffiliation': 'Peking University First Hospital'}}}}