Patient-centered Evaluative Assessment of Cardiac Events: Retrospective Study of Acute Myocardial Infarction (PEACE-R-AMI)
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Purpose
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, 35,000 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 |
|---|
|
Coronary Heart Disease |
| Study Type: | Observational |
| Study Design: | Observational Model: Case-Only Time Perspective: Retrospective |
| Official Title: | Patient-centered Evaluative Assessment of Cardiac Events: Retrospective Study of Patients With Acute Myocardial Infarction |
- Number of all-cause death [ Time Frame: Duration of hospital stay, an expected average of 1 week ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 35000 |
| Study Start Date: | April 2012 |
| Estimated Study Completion Date: | April 2013 |
| Estimated Primary Completion Date: | April 2013 (Final data collection date for primary outcome measure) |
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, 18,000 AMI cases will be selected in 2011, and 8,500 in 2001 and 2006 separately. Photocopies of the 35,000 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.
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
Using a stratified two-stage cluster sampling design, 175 hospitals will be selected from different regions in China, and 18,000 AMI inpatient cases will be selected in 2011, and 8,500 in 2001 and 2006 separately, from these sample hospitals.
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| 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
No publications provided
| Responsible Party: | China National Center for Cardiovascular Diseases |
| ClinicalTrials.gov Identifier: | NCT01624883 History of Changes |
| Other Study ID Numbers: | WSGY-201202025-1 |
| Study First Received: | June 17, 2012 |
| Last Updated: | June 20, 2012 |
| Health Authority: | China: Ministry of Health |
Additional relevant MeSH terms:
|
Coronary Artery Disease Myocardial Ischemia Coronary Disease Heart Diseases Infarction Myocardial Infarction Cardiovascular Diseases |
Arteriosclerosis Arterial Occlusive Diseases Vascular Diseases Ischemia Pathologic Processes Necrosis |
ClinicalTrials.gov processed this record on May 16, 2013