China PEACE-Retrospective AMI Study

NCT ID: NCT01624883

Last Updated: 2014-07-01

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 18000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2012-04-30
• Study Completion Date: 2013-08-31

Brief Summary

Coronary heart disease (CHD) and heart attacks pose a serious health risk to men and women, however the knowledge about the real-life AMI management in China is limited. Within a nation-wide and regional representative probability sample of hospitals in China, 27,800 AMI inpatient cases will be sampled randomly from 2001 to 2011. The sampled medical records will be reviewed and abstracted in the national coordinating centre, in order to evaluate the treatment pattern, outcomes, and cost for AMI patients, during the past decade. Basic data and innovative evidence will accelerate evidence-based clinical practice and policy making, and improve AMI patients outcomes finally.

Detailed Description

Cardiovascular disease (CVD) is a major concern in public health globally, as well as in China, and remarkable variations of resources available and health system performance have been noted. Relatively limited information is available about how evidence-based therapies are incorporated appropriately into routine clinical practice. In addition, little information is available about the magnitude, prognosis, and optimal management of AMI, which is one of the leading causes of mortality and morbidity, both in rural and urban area. Practical and applied knowledge from large unselected population is needed to guide practice and policy for quality improvement and cost reduction.

To investigate the treatment pattern and outcomes of AMI patients during the past decade in China, using a stratified two-stage cluster sampling design, from 175 sampled hospitals, 13,900 AMI cases will be selected in 2011, and 6,950 in 2001 and 2006 separately. Photocopies of the 27,800 medical records of AMI cases will be sent to the national coordinating centre. Demographic characteristics, medical history, clinical features, diagnostic tests, medications, procedures, and in-hospital outcomes of patients will be abstracted by well trained professional abstractors. By characterizing differences in patients' features, comparing the use of medications and procedures, and examining the in-hospital outcomes, we'll define the gaps between clinical practice and guidelines, as well as the disparities across different regions and hospitals, to evaluated the treatment pattern and outcomes in the last decade in China. New knowledge will be generated about AMI management all over China, to provide evidence for policy-making and clinical guidelines, and to improve AMI patients prognosis in future finally.

Conditions

Coronary Heart Disease

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: RETROSPECTIVE

Eligibility Criteria

Inclusion Criteria

• Hospitalized patients with acute myocardial infarction (AMI) according to discharge diagnosis (ICD-9 codes 410 or ICD-10 codes I21)

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ministry of Health, China

OTHER_GOV

Sponsor Role: collaborator

China National Center for Cardiovascular Diseases

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lixin Jiang, M.D., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

China National Center for Cardiovascular Diseases

Harlan M Krumholz, M.D., S.M.

Role: PRINCIPAL_INVESTIGATOR

Yale University

References

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Other Identifiers

WSGY-201202025-1

Identifier Type: -

Identifier Source: org_study_id