Acute Myocardial Infarction Clinical Trial
— AMI-COPSOfficial title:
The Characteristics and Clinical Outcomes of Acute Myocardial Infarction
NCT number | NCT02737956 |
Other study ID # | 20160317-03 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | June 1, 2012 |
Est. completion date | December 10, 2023 |
Verified date | March 2024 |
Source | Xinjiang Medical University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 7350 |
Est. completion date | December 10, 2023 |
Est. primary completion date | May 31, 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 79 Years |
Eligibility | Inclusion Criteria: Acute 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). Exclusion Criteria: 1. Combined with severe valvular heart disease; 2. Combined with severe congenital heart disease; 3. Combined hyperthyroidism, anemia and other high-powered heart disease; 4. With pulmonary heart disease; 5. With hypertrophic obstructive cardiomyopathy; 6. Severe hypotension (SBP <90mmHg or DBP <60mmHg at enrollment); 7. Uncontrolled hypertension (SBP> 160 mmHg before PCI, and / or DBP> 100 mmHg); 8. Liver dysfunction (defined as ALT or total bilirubin is greater than the normal upper limit of 3 times); 9. Renal insufficiency (defined as serum creatinine greater than 1.5 times the normal upper limit); 10. High-risk bleeding patients, such as thrombocytopenia, blood diseases and other diseases; 11. active peptic ulcer and skin ulcers; 12. A patient who is allergic to clopidogrel, tegrellol, or aspirin; 13. Patients with a history of cardiogenic shock within two weeks; 14. pregnant and lactating women, during treatment can not be strict contraception of women of childbearing age; 15. In the past 3 months participated in other clinical researchers; 16. Persons who do not have legal or legal competence; 17. Any condition that the investigator considers unsuitable for participation in the clinical study. |
Country | Name | City | State |
---|---|---|---|
China | First Affilliatted Hospital of Xinjiang Medical University | Ürümqi | Xinjiang |
Lead Sponsor | Collaborator |
---|---|
Xinjiang Medical University |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Death | All-cause mortality, Cardiac mortality | 5 years | |
Secondary | Major adverse cardiovascular events (MACE) | Cardiac death, non-fatal myocardial infarction, and target vessel revascularization. | 5 years | |
Secondary | Major adverse cardiovascular and cerebrovascular events (MACCE) | Cardiac death, non-fatal myocardial infarction, target vessel revascularization and stroke. | 5 years | |
Secondary | stroke | ischemic stroke and hemorrhage | 5 years |
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