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Clinical Trial Details — Status: Completed

Administrative data

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

Study information

Verified date March 2024
Source Xinjiang Medical University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


Description:

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.


Recruitment information / eligibility

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.

Study Design


Locations

Country Name City State
China First Affilliatted Hospital of Xinjiang Medical University Ürümqi Xinjiang

Sponsors (1)

Lead Sponsor Collaborator
Xinjiang Medical University

Country where clinical trial is conducted

China, 

Outcome

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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