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| Name | Class |
|---|---|
| Ministry of Health, China | OTHER_GOV |
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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.
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.
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| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Symptoms status (SAQ) | 1 year | |
| Quality of life (EQ-5D) | 1 year | |
| Depression (PHQ-8) |
| Measure | Description | Time Frame |
|---|---|---|
| Cognitive function (MMSE) | 1 year | |
| Sexual activity/function | 1 year |
Inclusion Criteria:
Exclusion Criteria:
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In 40 hospitals of different levels in China, 4000 hospitalized patients with acute myocardial infarction will be enrolled consecutively.
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| Name | Affiliation | Role |
|---|---|---|
| Lixin Jiang, M.D., Ph.D. | China National Center for Cardiovascular Diseases | Principal Investigator |
| Harlan M Krumholz, M.D., S.M. | Yale University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fuwai Hospital | Beijing | Beijing Municipality | 100037 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31092023 | Derived | 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. | |
| 31057004 | Derived | 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. |
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| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
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A venous blood sample of 20mL will be collected at 1-month visit and 12-month visit for biomarker analysis and storage for future genetic studies;
A urine samples of 40mL will be collected at 1-month visit and 12-month visit for biomarker analysis and storage.
| 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 |
| 30661037 | Derived | 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. |
| 30646375 | Derived | 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. |
| 29878087 | Derived | 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. |
| 29579607 | Derived | 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. |