Clinical trial NCT01624883: China PEACE-Retrospective AMI Study
Official title: The China PEACE (Patient-centered Evaluative Assessment of Cardiac Events Retrospective Study of Acute Myocardial Infarction
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronary Heart Disease
Lead sponsor: China National Center for Cardiovascular Diseases
Sponsor class: OTHER_GOV
Collaborators: name: Ministry of Health, China
First posted: 2012-06-21
Enrollment: 18000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
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.

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.

Eligibility 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:

Primary outcomes:
measure: Number of all-cause death
timeFrame: Duration of hospital stay, an expected average of 1 week
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: China National Center for Cardiovascular Diseases
name: Lixin Jiang, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Yale University
name: Harlan M Krumholz, M.D., S.M.
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Li X, Murugiah K, Li J, Masoudi FA, Chan PS, Hu S, Spertus JA, Wang Y, Downing NS, Krumholz HM, Jiang L; China PEACE Collaborative Group. Urban-Rural Comparisons in Hospital Admission, Treatments, and Outcomes for ST-Segment-Elevation Myocardial Infarction in China From 2001 to 2011: A Retrospective Analysis From the China PEACE Study (Patient-Centered Evaluative Assessment of Cardiac Events). Circ Cardiovasc Qual Outcomes. 2017 Nov;10(11):e003905. doi: 10.1161/CIRCOUTCOMES.117.003905.
citation: Murugiah K, Wang Y, Nuti SV, Li X, Li J, Zheng X, Downing NS, Desai NR, Masoudi FA, Spertus JA, Jiang L, Krumholz HM; China PEACE Collaborative Group. Are non-ST-segment elevation myocardial infarctions missing in China? Eur Heart J Qual Care Clin Outcomes. 2017 Oct 1;3(4):319-327. doi: 10.1093/ehjqcco/qcx025.
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citation: Guan W, Murugiah K, Downing N, Li J, Wang Q, Ross JS, Desai NR, Masoudi FA, Spertus JA, Li X, Krumholz HM, Jiang L; China PEACE Collaborative Group. National quality assessment evaluating spironolactone use during hospitalization for acute myocardial infarction (AMI) in China: China Patient-centered Evaluation Assessment of Cardiac Events (PEACE)-Retrospective AMI Study, 2001, 2006, and 2011. J Am Heart Assoc. 2015 Jun 12;4(6):e001718. doi: 10.1161/JAHA.114.001718.
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citation: Liu J, Masoudi FA, Spertus JA, Wang Q, Murugiah K, Spatz ES, Li J, Li X, Ross JS, Krumholz HM, Jiang L; China PEACE Collaborative Group. Patterns of use of angiotensin-converting enzyme inhibitors/angiotensin receptor blockers among patients with acute myocardial infarction in China from 2001 to 2011: China PEACE-Retrospective AMI Study. J Am Heart Assoc. 2015 Feb 23;4(2):e001343. doi: 10.1161/JAHA.114.001343.
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citation: Gao Y, Masoudi FA, Hu S, Li J, Zhang H, Li X, Desai NR, Krumholz HM, Jiang L; China PEACE Collaborative Group. Trends in early aspirin use among patients with acute myocardial infarction in China, 2001-2011: the China PEACE-Retrospective AMI study. J Am Heart Assoc. 2014 Oct 10;3(5):e001250. doi: 10.1161/JAHA.114.001250.
citation: Li J, Li X, Wang Q, Hu S, Wang Y, Masoudi FA, Spertus JA, Krumholz HM, Jiang L; China PEACE Collaborative Group. ST-segment elevation myocardial infarction in China from 2001 to 2011 (the China PEACE-Retrospective Acute Myocardial Infarction Study): a retrospective analysis of hospital data. Lancet. 2015 Jan 31;385(9966):441-51. doi: 10.1016/S0140-6736(14)60921-1. Epub 2014 Jun 23.
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