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Coronary Heart DiseaseNCT01624909

China PEACE-Prospective AMI Study

An observational study of Coronary Heart Disease, run by China National Center for Cardiovascular Diseases at 1 site in China.

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 little information is available about how evidence-based therapies are incorporated appropriately into routine clinical practice in China. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Coronary Heart Disease
How many people
4,286 participants
Where
1 siteChina
Study dates
Dec 2012to Jul 2015
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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: In 40 hospitals of different levels in China, 4000 hospitalized patients with acute myocardial infarction will be enrolled consecutively.

Who may be able to join

  • Hospitalized patients with acute myocardial infarction according to positive cardiac biomarkers (Troponin I/T, CK-MB or CK≥ local laboratory upper limit of normal values within 24 hours after initial presentation, and at least one of the following two supporting evidence of ischemia (ischemic symptoms occurring within 24 hours before admission or up to 72 hours for STEMI; ECG changes indicative of new ischemia).

Who cannot join

  • Previously enrolled in the PEACE study

Trial locations and contacts

1 site in 1 country.

China1 site

  • Fuwai Hospital

    Beijing, Beijing Municipality, 100037

Other trials in China

About this study

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

Coronary heart disease (CHD) and heart attacks pose a serious health risk to men and women, however little information is available about how evidence-based therapies are incorporated appropriately into routine clinical practice in China. In addition, basic data and evidence about safety and efficacy of treatment for AMI is limited. By consecutively recruiting AMI patients in 40 hospitals of different levels, this study will examine various real-life factors, that may affect patients recovery after a heart attack. Practical guidelines and risk model for AMI patients will be established based on the findings, to improve patients outcomes in future finally.

Read the detailed description

Cardiovascular disease (CVD) is a major concern in public health globally, as well as in China, and AMI is one of the leading causes of mortality and morbidity. Remarkable variations of resources available and health system performance have been noted, however little information is available about how evidence-based therapies are incorporated appropriately into routine clinical practice in China. In addition, basic data and evidence about safety, efficacy, and effectiveness of treatment for AMI during long-term recovery is limited. Practical and applied knowledge from large unselected population is needed to guide practice and policy for quality improvement and cost reduction.

This study will enroll patients with a confirmed diagnosis of AMI consecutively in 20 tertiary hospitals and 20 secondary hospitals scattered all over China. At study entry, participants will be interviewed during their index hospitalization, to collect information about symptoms, functioning, quality of life, and medical care. Demographic characteristics, medical history, clinical features, diagnostic tests, medications, procedures, and in-hospital outcomes of patients will be abstracted from medical records by well trained professional abstractors. At 1 month, 6 month, and 12 month after discharge, participants will return to the clinic for follow up visits, a face-to-face interview will be conducted to get information about clinical events, symptoms, functioning, quality of life, and medical care during the recovery period. At 1-Month and 12-Month follow-up visit, blood and urine sample will be collected. Participants' blood samples will be stored for future biologic and genetic studies. This study will examine various real-life factors that may affect patients recovery after a heart attack, including patients' characteristics and treatment measures. Practical guidelines, quality evaluative system, and risk model for AMI patients will be established based on the findings, to improve patients outcomes 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. Major adverse cardiovascular events (MACE)

    Composite of major adverse cardiovascular events (MACE) including cardiac death, non-fatal AMI, coronary revascularization procedure, or ischemic stroke.

    Measured: 1 year

Secondary outcomes (11)

  1. Symptoms status (SAQ)

    Measured: 1 year

  2. Quality of life (EQ-5D)

    Measured: 1 year

  3. Depression (PHQ-8)

    Measured: 1 year

  4. Stress (PSS-4)

    Measured: 1 year

  5. Cardiac death

    Measured: 1 year

  6. Fatal or non-fatal AMI

    Measured: 1 year

  7. Coronary revascularization procedure

    Measured: 1 year

  8. Ischemic stroke

    Measured: 1 year

  9. Re-admission

    Measured: 1 year

  10. Adherence to medications for secondary prevention

    Taking the following medications for 6 or more days per week: aspirin, clopidogrel, ACEI/ARB, statin and beta-blockers

    Measured: 1 year

  11. Control of risk factors

    Control of hypertension, diabetes, dyslipidemia, smoking, and obesity

    Measured: 1 year

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 startDec 2012
  3. Primary completionMay 2014
  4. Study completionJul 2015

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
Cohort
Time perspective
Prospective
Enrolment
4,286 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01624909
Sponsor's protocol ID
WSGY-201202025-3
Status last verified
Aug 2015
First submitted
17 Jun 2012
Last updated
31 Aug 2015
Results posted
No
Data monitoring committee
Yes

Publications

  • Li J, Dharmarajan K, Bai X, Masoudi FA, Spertus JA, Li X, Zheng X, Zhang H, Yan X, Dreyer RP, Krumholz HM. Thirty-Day Hospital Readmission After Acute Myocardial Infarction in China. Circ Cardiovasc Qual Outcomes. 2019 May;12(5):e005628. doi: 10.1161/CIRCOUTCOMES.119.005628.

    PubMed 31092023

  • Shang P, Liu GG, Zheng X, Ho PM, Hu S, Li J, Jiang Z, Li X, Bai X, Gao Y, Xing C, Wang Y, Normand SL, Krumholz HM. Association Between Medication Adherence and 1-Year Major Cardiovascular Adverse Events After Acute Myocardial Infarction in China. J Am Heart Assoc. 2019 May 7;8(9):e011793. doi: 10.1161/JAHA.118.011793.

    PubMed 31057004

  • Huo X, Khera R, Zhang L, Herrin J, Bai X, Wang Q, Lu Y, Nasir K, Hu S, Li J, Li X, Zheng X, Masoudi FA, Spertus JA, Krumholz HM, Jiang L. Education level and outcomes after acute myocardial infarction in China. Heart. 2019 Jun;105(12):946-952. doi: 10.1136/heartjnl-2018-313752. Epub 2019 Jan 19.

    PubMed 30661037

  • Jiang Z, Dreyer RP, Spertus JA, Masoudi FA, Li J, Zheng X, Li X, Wu C, Bai X, Hu S, Wang Y, Krumholz HM, Chen H; China Patient-centered Evaluative Assessment of Cardiac Events (PEACE) Collaborative Group. Factors Associated With Return to Work After Acute Myocardial Infarction in China. JAMA Netw Open. 2018 Nov 2;1(7):e184831. doi: 10.1001/jamanetworkopen.2018.4831.

    PubMed 30646375

  • Guan W, Venkatesh AK, Bai X, Xuan S, Li J, Li X, Zhang H, Zheng X, Masoudi FA, Spertus JA, Krumholz HM, Jiang L. Time to hospital arrival among patients with acute myocardial infarction in China: a report from China PEACE prospective study. Eur Heart J Qual Care Clin Outcomes. 2019 Jan 1;5(1):63-71. doi: 10.1093/ehjqcco/qcy022.

    PubMed 29878087

  • 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

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 at 1 site in China.

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 1 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 31 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

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?

Major adverse cardiovascular events (MACE) (time frame: 1 year). 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 NCT01624909, which also lists 6 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 31 Aug 2015.

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