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China PEACE-Retrospective AMI Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01624883
Recruitment Status : Completed
First Posted : June 21, 2012
Last Update Posted : July 1, 2014
Sponsor:
Collaborator:
Ministry of Health, China
Information provided by (Responsible Party):
China National Center for Cardiovascular Diseases

Study Description
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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.

Condition or disease
Coronary Heart Disease

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.

Study Design
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Study Type : Observational
Actual Enrollment : 18000 participants
Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: The China PEACE (Patient-centered Evaluative Assessment of Cardiac Events Retrospective Study of Acute Myocardial Infarction
Study Start Date : April 2012
Actual Primary Completion Date : August 2013
Actual Study Completion Date : August 2013

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. Number of all-cause death [ Time Frame: Duration of hospital stay, an expected average of 1 week ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Using a stratified two-stage cluster sampling design, 175 hospitals will be selected from different regions in China, and 13,900 AMI inpatient cases will be selected in 2011, and 6,950 in 2001 and 2006 separately, from these sample hospitals.
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01624883


Sponsors and Collaborators
China National Center for Cardiovascular Diseases
Ministry of Health, China
Investigators
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Principal Investigator: Lixin Jiang, M.D., Ph.D. China National Center for Cardiovascular Diseases
Principal Investigator: Harlan M Krumholz, M.D., S.M. Yale University
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: China National Center for Cardiovascular Diseases
ClinicalTrials.gov Identifier: NCT01624883    
Other Study ID Numbers: WSGY-201202025-1
First Posted: June 21, 2012    Key Record Dates
Last Update Posted: July 1, 2014
Last Verified: June 2014
Additional relevant MeSH terms:
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Heart Diseases
Coronary Disease
Coronary Artery Disease
Myocardial Ischemia
 Cardiovascular Diseases
Vascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases