Ignite Creation Date:
2025-12-24 @ 11:38 PM
Ignite Modification Date:
2026-04-08 @ 8:46 PM
Study NCT ID:
NCT02737956
Status:
COMPLETED
Last Update Posted:
2024-03-28
First Post:
2016-04-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Prognosis of Acute Myocardial Infarction
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 7350}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2023-12-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-03-26', 'studyFirstSubmitDate': '2016-04-05', 'studyFirstSubmitQcDate': '2016-04-10', 'lastUpdatePostDateStruct': {'date': '2024-03-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-04-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-05-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Death', 'timeFrame': '5 years', 'description': 'All-cause mortality, Cardiac mortality'}], 'secondaryOutcomes': [{'measure': 'Major adverse cardiovascular events (MACE)', 'timeFrame': '5 years', 'description': 'Cardiac death, non-fatal myocardial infarction, and target vessel revascularization.'}, {'measure': 'Major adverse cardiovascular and cerebrovascular events (MACCE)', 'timeFrame': '5 years', 'description': 'Cardiac death, non-fatal myocardial infarction, target vessel revascularization and stroke.'}, {'measure': 'stroke', 'timeFrame': '5 years', 'description': 'ischemic stroke and hemorrhage'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Acute Myocardial Infarction']}, 'referencesModule': {'references': [{'pmid': '39077519', 'type': 'DERIVED', 'citation': 'Yan J, Deng CJ, Wang SF, Aimaitijiang M, Wu TT, Zheng YY, Xie X, Ma YT. Predictive Value of the Modified GRACE Scoring System for All-Cause Mortality in Patients with Acute Myocardial Infarction. Rev Cardiovasc Med. 2023 Jun 6;24(6):161. doi: 10.31083/j.rcm2406161. eCollection 2023 Jun.'}, {'pmid': '31772517', 'type': 'DERIVED', 'citation': 'Xiu WJ, Yang HT, Zheng YY, Ma YT, Xie X. Delayed PCI 12 Hours after the Onset of Symptoms Is Associated with Improved Outcomes for Patients with ST-Segment Elevation Myocardial Infarction: A Real-World Study. J Interv Cardiol. 2019 Jun 18;2019:2387929. doi: 10.1155/2019/2387929. eCollection 2019.'}]}, 'descriptionModule': {'briefSummary': 'This study aims to establish a registry and surveillance system for acute myocardial infarction (AMI) patients in Xinjiang, focusing on collecting comprehensive information including basic patient demographics, patient characteristics, diagnostic methods, treatment programs, and hospitalization outcomes such as mortality, treatment complications, hospitalization costs, and follow-up events (death, major adverse cardiac events). The goal is to identify and propose effective prevention strategies to reduce the incidence of AMI, optimize the management and outcomes of AMI patients by implementing guideline recommendations in clinical practice, and conduct analyses to develop effective treatment strategies and predictive models for clinical outcomes. This focus on Xinjiang aims to provide a comprehensive understanding of AMI within this specific geographic and demographic context, ultimately contributing to improved prevention, treatment, and management of AMI patients.', 'detailedDescription': 'The objective of this study is to establish a comprehensive registry and surveillance system for acute myocardial infarction (AMI) patients in Xinjiang. This platform is designed to support clinical research and translational medicine, aiming to improve the quality of AMI patient care through the integration of guideline recommendations into clinical practice. By collecting detailed information on patient demographics, characteristics, diagnostic methods, treatment programs, and outcomes, including mortality, complications, hospitalization costs, and follow-up events such as death and major adverse cardiac events, this study seeks to lay the foundation for future quality improvement initiatives and research. The ultimate goal is to translate research findings into improved care practices for AMI patients, thereby reducing morbidity and mortality associated with the condition. This endeavor will bridge the gap between clinical research and practical healthcare delivery, ensuring that advancements in the treatment and management of AMI directly benefit patients in Xinjiang, contributing to substantial improvements in healthcare outcomes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '79 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'The study population consists of acute myocardial infarction (AMI) patients hospitalized at the First Affiliated Hospital of Xinjiang Medical University. This includes individuals diagnosed with both acute ST-elevation myocardial infarction (STEMI) and non-ST-elevation myocardial infarction (NSTEMI).', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nAcute myocardial infarction patients in hospitalized of the First Affiliated Hospital of Xinjiang Medical University (include diagnosed acute ST-elevation or non ST-elevation myocardial infarction).Diagnosis criteria must meet Universal Definition for AMI (2012).\n\nExclusion Criteria:\n\n1. Combined with severe valvular heart disease;\n2. Combined with severe congenital heart disease;\n3. Combined hyperthyroidism, anemia and other high-powered heart disease;\n4. With pulmonary heart disease;\n5. With hypertrophic obstructive cardiomyopathy;\n6. Severe hypotension (SBP \\<90mmHg or DBP \\<60mmHg at enrollment);\n7. Uncontrolled hypertension (SBP\\> 160 mmHg before PCI, and / or DBP\\> 100 mmHg);\n8. Liver dysfunction (defined as ALT or total bilirubin is greater than the normal upper limit of 3 times);\n9. Renal insufficiency (defined as serum creatinine greater than 1.5 times the normal upper limit);\n10. High-risk bleeding patients, such as thrombocytopenia, blood diseases and other diseases;\n11. active peptic ulcer and skin ulcers;\n12. A patient who is allergic to clopidogrel, tegrellol, or aspirin;\n13. Patients with a history of cardiogenic shock within two weeks;\n14. pregnant and lactating women, during treatment can not be strict contraception of women of childbearing age;\n15. In the past 3 months participated in other clinical researchers;\n16. Persons who do not have legal or legal competence;\n17. Any condition that the investigator considers unsuitable for participation in the clinical study.'}, 'identificationModule': {'nctId': 'NCT02737956', 'acronym': 'AMI-COPS', 'briefTitle': 'The Prognosis of Acute Myocardial Infarction', 'organization': {'class': 'OTHER', 'fullName': 'Xinjiang Medical University'}, 'officialTitle': 'The Characteristics and Clinical Outcomes of Acute Myocardial Infarction', 'orgStudyIdInfo': {'id': '20160317-03'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'AMI patients with treatment of PCI', 'description': 'All the patiets treat with PCI were enrolled and recorded the clinical characteristic and outcomes during the follow-up period.'}, {'label': 'Medication', 'description': 'All the patiets treat with medication (standard secondary prevention) without PCI were enrolled and recorded the clinical characteristic and outcomes during the follow-up period.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '830011', 'city': 'Ürümqi', 'state': 'Xinjiang', 'country': 'China', 'facility': 'First Affilliatted Hospital of Xinjiang Medical University', 'geoPoint': {'lat': 43.80096, 'lon': 87.60046}}], 'overallOfficials': [{'name': 'Xiang Xie, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Xinjiang Medical University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Xinjiang Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Xiangxie, MD,Professor, The First Affiliated Hospital Of XinJiang Medicial University', 'investigatorFullName': 'Xiang Xie', 'investigatorAffiliation': 'Xinjiang Medical University'}}}}