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Coronary Heart DiseaseNCT01624883

China PEACE-Retrospective AMI Study

An observational study of Coronary Heart Disease, run by China National Center for Cardiovascular Diseases.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Any age
Conditions the study is for
Coronary Heart Disease
How many people
18,000 participants
Where
No sites listed yet
Study dates
Apr 2012to Aug 2013
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

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.

Who may be able to join

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

Who cannot join

None listed.

About this study

Official title: The China PEACE (Patient-centered Evaluative Assessment of Cardiac Events Retrospective Study of Acute Myocardial Infarction

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.

Read the 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.

Medical subject headings
Coronary Disease

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of all-cause death

    Measured: Duration of hospital stay, an expected average of 1 week

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Jun 2012 (estimated)
  2. Study startApr 2012
  3. Primary completionAug 2013
  4. Study completionAug 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Retrospective
Enrolment
18,000 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01624883
Sponsor's protocol ID
WSGY-201202025-1
Status last verified
Jun 2014
First submitted
17 Jun 2012
Last updated
1 Jul 2014
Results posted
No
Data monitoring committee
Yes

Publications

  • Guo W, Du X, Gao Y, Hu S, Lu Y, Dreyer RP, Li X, Spatz ES, Masoudi FA, Krumholz HM, Zheng X. Sex Differences in Characteristics, Treatments, and Outcomes Among Patients Hospitalized for Non-ST-Segment-Elevation Myocardial Infarction in China: 2006 to 2015. Circ Cardiovasc Qual Outcomes. 2022 Jun;15(6):e008535. doi: 10.1161/CIRCOUTCOMES.121.008535. Epub 2022 May 24.

    PubMed 35607994

  • Wang X, Du X, Yang H, Bucholz E, Downing N, Spertus JA, Masoudi FA, Li J, Guan W, Gao Y, Hu S, Bai X, Krumholz HM, Li X. Use of intravenous magnesium sulfate among patients with acute myocardial infarction in China from 2001 to 2015: China PEACE-Retrospective AMI Study. BMJ Open. 2020 Mar 26;10(3):e033269. doi: 10.1136/bmjopen-2019-033269.

    PubMed 32220910

  • Spatz ES, Wang Y, Beckman AL, Wu X, Lu Y, Du X, Li J, Xu X, Davidson PM, Masoudi FA, Spertus JA, Krumholz HM, Jiang L. Traditional Chinese Medicine for Acute Myocardial Infarction in Western Medicine Hospitals in China. Circ Cardiovasc Qual Outcomes. 2018 Mar;11(3):e004190. doi: 10.1161/CIRCOUTCOMES.117.004190.

    PubMed 29848478

  • Qi Y, Wang W, Zhang K, An S, Wang S, Zheng J, Tang YD. Development and validation of Women Acute Myocardial Infarction in-Hospital Mortality Score (WAMI Score). Int J Cardiol. 2018 May 15;259:31-39. doi: 10.1016/j.ijcard.2017.12.010.

    PubMed 29579607

  • 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.

    PubMed 29158421

  • 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.

    PubMed 28950309

  • Downing NS, Wang Y, Dharmarajan K, Nuti SV, Murugiah K, Du X, Zheng X, Li X, Li J, Masoudi FA, Spertus JA, Jiang L, Krumholz HM. Quality of Care in Chinese Hospitals: Processes and Outcomes After ST-segment Elevation Myocardial Infarction. J Am Heart Assoc. 2017 Jun 23;6(6):e005040. doi: 10.1161/JAHA.116.005040.

    PubMed 28645937

  • Zhao S, Murugiah K, Li N, Li X, Xu ZH, Li J, Cheng C, Mao H, Downing NS, Krumholz HM, Jiang LX. Admission Glucose and In-hospital Mortality after Acute Myocardial Infarction in Patients with or without Diabetes: A Cross-sectional Study. Chin Med J (Engl). 2017 Apr 5;130(7):767-775. doi: 10.4103/0366-6999.202733.

    PubMed 28345539

  • Li X, Li J, Masoudi FA, Spertus JA, Lin Z, Krumholz HM, Jiang L; China PEACE Collaborative Group. China PEACE risk estimation tool for in-hospital death from acute myocardial infarction: an early risk classification tree for decisions about fibrinolytic therapy. BMJ Open. 2016 Oct 24;6(10):e013355. doi: 10.1136/bmjopen-2016-013355.

    PubMed 27798032

  • Li J, Li X, Hu S, Yu Y, Yan XF, Jiang LX. [ST-segment elevation myocardial infarction in the eastern urban China: from 2001 to 2011]. Zhonghua Xin Xue Guan Bing Za Zhi. 2016 Apr 24;44(4):303-8. doi: 10.3760/cma.j.issn.0253-3758.2016.04.006. Chinese.

    PubMed 27112607

  • Du X, Spatz ES, Dreyer RP, Hu S, Wu C, Li X, Li J, Wang S, Masoudi FA, Spertus JA, Nasir K, Krumholz HM, Jiang L; China PEACE Collaborative Group. Sex Differences in Clinical Profiles and Quality of Care Among Patients With ST-Segment Elevation Myocardial Infarction From 2001 to 2011: Insights From the China Patient-Centered Evaluative Assessment of Cardiac Events (PEACE)-Retrospective Study. J Am Heart Assoc. 2016 Feb 22;5(2):e002157. doi: 10.1161/JAHA.115.002157.

    PubMed 26903002

  • Zhang H, Masoudi FA, Li J, Wang Q, Li X, Spertus JA, Ross JS, Desai NR, Krumholz HM, Jiang L; China PEACE Collaborative Group. National assessment of early beta-blocker therapy in patients with acute myocardial infarction in China, 2001-2011: The China Patient-centered Evaluative Assessment of Cardiac Events (PEACE)-Retrospective AMI Study. Am Heart J. 2015 Sep;170(3):506-15.e1. doi: 10.1016/j.ahj.2015.05.012. Epub 2015 May 22.

    PubMed 26385034

  • Zhang L, Desai NR, Li J, Hu S, Wang Q, Li X, Masoudi FA, Spertus JA, Nuti SV, Wang S, Krumholz HM, Jiang L; China PEACE Collaborative Group. National Quality Assessment of Early Clopidogrel Therapy in Chinese Patients With Acute Myocardial Infarction (AMI) in 2006 and 2011: Insights From the China Patient-Centered Evaluative Assessment of Cardiac Events (PEACE)-Retrospective AMI Study. J Am Heart Assoc. 2015 Jul 10;4(7):e001906. doi: 10.1161/JAHA.115.001906.

    PubMed 26163041

  • 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.

    PubMed 26071031

  • Zhan L, Masoudi FA, Li X, Hu S, Venkatesh AK, Spertus JA, Lin Z, Desai NR, Li J, Krumholz HM, Jiang L; China PEACE Collaborative Group. Trends in cardiac biomarker testing in China for patients with acute myocardial infarction, 2001 to 2011: China PEACE-retrospective AMI study. PLoS One. 2015 Apr 20;10(3):e0122237. doi: 10.1371/journal.pone.0122237. eCollection 2015.

    PubMed 25893247

Questions about this trial

What is this clinical trial studying?

An observational study of Coronary Heart Disease, run by China National Center for Cardiovascular Diseases.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of all-cause death (time frame: Duration of hospital stay, an expected average of 1 week). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01624883, which also lists 20 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2014.

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China PEACE-Retrospective AMI Study (NCT01624883) | AzTrials