System Delay and Clinical Outcome Among Chinese Patients With AMI Treated With Reperfusion Therapy (MOODY Study)

Study Overview
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Brief Summary
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Acute myocardial infarction (AMI) pose a pool clinical outcome to men and women whom treatment was delayed. However, reperfusion time was limited in previous studies. To evaluate the system delay and clinical outcomes among Chinese patients with AMI, consecutive inpatient case prospectively collected from 1999 to 2016. Basic data and innovative evidence will accelerate evidence-based clinical practice and policy making, and improve AMI patients outcomes finally.

Detailed Description
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AMI is one of the leading causes of mortality and morbidity in public health globally, as well as in China. Remarkable variations of repercussion time and clinical outcome have been noted, however little information is available about how shortened D2B time is incorporated appropriately into routine clinical practice in China. In addition, basic data and evidence about effectiveness of treatment for AMI during long-term recovery is limited. Practical and applied knowledge from large unselected population is needed to guide practice for improvement. This study will enroll patients with a confirmed diagnosis of AMI consecutively in 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, and 12 month after discharge, participants will return to the clinic for follow up visits. This study will examine system delay that may affect patients recovery after a heart attack. Effective clinic path system, and risk model for AMI patients will be established based on the findings, to improve patients outcomes in future finally.

Official Title
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System Delay and Clinical Outcome Among Chinese Patients With AMI Treated With Reperfusion Therapy (MOODY Study)

Conditions
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Coronary Heart Disease

Intervention / Treatment
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* Procedure: Reperfusion


Participation Criteria
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Eligibility Criteria
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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 similar study

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Group 1<br>The patient received reperfusion therapy between 1999 January 1 and 2009 December 31 | Procedure: Reperfusion<br> <br> |
| Group 2<br>The patient received reperfusion therapy between 2010 January 1 and 2016 December 31 | Procedure: Reperfusion<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 30-Day Freedom From Mortality | All-cause death | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 12-Month Freedom From Major Adverse Cardiac Events (MACE) | Composite of MACE including cardiac death, non-fatal AMI, and clinically driven target vessel revascularization. | 12 months | 
| Cardiac death | Death that could not be attributed to a noncardiac etiology was considered cardiac death. | 12 months | 
| Myocardial infarction | Myocardial infarction was diagnosed by electrocardiographic changes and/or a rise and fall of creatine kinase-myocardial band fraction in the presence of ischemic symptoms. | 12 months | 
| Target vessel revascularization | Target vessel revascularization was defined as repeated revascularization by PCI or surgery of the target vessel. | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Acute Myocardial Infarction