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China PEACE-Prospective AMI Study

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01624909
Enrollment
4286
Registered
2012-06-21
Start date
2012-12-31
Completion date
2015-07-31
Last updated
2015-08-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary Heart Disease

Brief 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. 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.

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.

Interventions

None listed

Sponsors

Ministry of Health, China
CollaboratorOTHER_GOV
China National Center for Cardiovascular Diseases
Lead SponsorOTHER_GOV

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* 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).

Exclusion criteria

* Previously enrolled in the PEACE study

Design outcomes

Primary

MeasureTime frameDescription
Major adverse cardiovascular events (MACE)1 yearComposite of major adverse cardiovascular events (MACE) including cardiac death, non-fatal AMI, coronary revascularization procedure, or ischemic stroke.

Secondary

MeasureTime frameDescription
Symptoms status (SAQ)1 year
Quality of life (EQ-5D)1 year
Depression (PHQ-8)1 year
Stress (PSS-4)1 year
Cardiac death1 year
Fatal or non-fatal AMI1 year
Adherence to medications for secondary prevention1 yearTaking the following medications for 6 or more days per week: aspirin, clopidogrel, ACEI/ARB, statin and beta-blockers
Control of risk factors1 yearControl of hypertension, diabetes, dyslipidemia, smoking, and obesity
Coronary revascularization procedure1 year
Ischemic stroke1 year
Re-admission1 year

Other

MeasureTime frame
Cognitive function (MMSE)1 year
Sexual activity/function1 year

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 6, 2026