China PEACE-Prospective AMI Study

Study Overview
=================
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.

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

Conditions
-----------------
Coronary Heart Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Major adverse cardiovascular events (MACE) | Composite of major adverse cardiovascular events (MACE) including cardiac death, non-fatal AMI, coronary revascularization procedure, or ischemic stroke. | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Symptoms status (SAQ) |  | 1 year | 
| Quality of life (EQ-5D) |  | 1 year | 
| Depression (PHQ-8) |  | 1 year | 
| Stress (PSS-4) |  | 1 year | 
| Cardiac death |  | 1 year | 
| Fatal or non-fatal AMI |  | 1 year | 
| Coronary revascularization procedure |  | 1 year | 
| Ischemic stroke |  | 1 year | 
| Re-admission |  | 1 year | 
| 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 | 1 year | 
| Control of risk factors | Control of hypertension, diabetes, dyslipidemia, smoking, and obesity | 1 year |