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临床试验/NCT03387280
NCT03387280Unknown不适用

Electrocardigram Identifying the Culprit Site in Patients With Acute Inferior Myocardial Infarction

Yuan's General Hospital1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2015年1月最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
150
试验地点
1
主要终点
determine which criteria is the best one in predicting the culprit site

研究概览

简要总结

Acute myocardial infarction (AMI) usually occurs suddenly and is associated with considerably high mortality rate. The infarct-related artery in inferior wall AMI is usually located at right coronary artery (RCA), less often at left circumflex coronary artery (LCX). Inferior wall AMI occlusive site before the first right ventricular branch of RCA was more frequently associated with right ventricular infarction, which had higher incidence of bradyarrhythmia, shock, and in-hospital death. Early recognition of the site of infarct-related artery especially combination with right ventricular infarction and respond promptly may result in a significant reduction in in-hospital mortality and morbidity. There were several non-invasive methods to predict the culprit site, which including: radioneuclear imaging study, echocardiography or electrocardiogram. Among these methods, electrocardiogram is one of the most simple and convenient tool. Several algorisms have investigated but these algorisms included using leads III, II, I, aVL, V1, V2, V3, V5 and V6, which can only differentiate RCA and LCX lesions but cannot assure whether the culprit site is located at proximal or distal RCA. Thus, the aim of this study is designing a method which is simple and useful in identifying the culprit sites in inferior wall acute myocardial infarction (AMI).

According to the medical record, patients with inferior wall AMI who have no previous history of MI (or the first AMI attack) will be enrolled. These patients are divided into 3 groups from coronary angiography, depending upon the culprit lesion (1) before (proximal) or (2) after (distal) the right ventricular branch of RCA and (3) LCX. A two-step study strategy will be performed to analyze which electrocardiographic variables are capable of discriminating the culprit site of coronary artery. Using the area under the receiver operating characteristic (ROC) curve analysis, we plan to determine which one of the above variables is the most powerful criterion in discriminating the culprit site of coronary artery. Due to the fact that the case number of the first inferior AMI will be limited, this study will be carried out at 3 hospitals in order to collect more cases with the coming year.

详细描述

Background

Acute myocardial infarction (AMI) usually occurs suddenly and is associated with considerably high mortality rate. The infarct-related artery in inferior wall AMI is usually located at right coronary artery (RCA), less often at left circumflex coronary artery (LCX). [1,2] Inferior wall AMI occlusive site above the first right ventricular branch of RCA was more frequently associated with right ventricular infarction, which had higher incidence of bradyarrhythmia, shock, and in-hospital death.[3-7] Early recognition of the site of infarct-related artery and respond promptly may result in a significant reduction in in-hospital mortality and morbidity.[8-10] Coronary angiography is considered to be the gold standard for determining the culprit site of infarct-related artery, but it is an invasive examination. Additionally, not all hospitals have the facility in performing the cardiac catheterization. There were several non-invasive methods to predict the culprit site including: radioneuclear imaging study, echocardiography or electrocardiogram. Among these methods, electrocardiogram is one of the most simple and useful tools. Several studies have used ST segment elevation in lead III > ST segment elevation in lead II and ST segment depression in lead I, aVL or both to predict that culprit site was located at RCA; ST segment elevation in lead I, aVL, V5 and V6 and ST segment depression in V1, V2 and V3 to predict that the culprit site was located at LCX. [11-24] These electrocardiogram readings including lead III, II, I, aVL, V1, V2, V3, V5 and V6 , which can only differentiate RCA and LCX lesions. If clinicians are intended to know whether the culprit site is located at proximal or distal RCA, further evaluation of the ST segment elevation in leads V1 and V4R,would be needed [25] which makes the algorithm involving too many leads and not so easy to remember. Thus, the aim of this study is designing a method which is simple and useful in identifying the culprit sites in inferior wall acute myocardial infarction (AMI).

Methods

Study Patients:

From review of the medical records, patients suffered from first inferior wall AMI will be enrolled in this study. The diagnosis of acute inferior AMI includes: 1) chest pain > 30 minutes; 2) ST elevation > 1mm in at least two of the three inferior lead (II, III, AVF); and 3) 2-fold increase in serum creatine kinase levels. At least 2 of the above 3 criteria are necessary to confirm the diagnosis. Right ventricular infarction is diagnosed by the presence of an ST-segment elevation of 0.1 mV in the V3R or V4R lead (recorded in all patients with inferior wall MI) in the electrocardiogram performed within 15 minutes after arrival at emergent department. Exclusion criteria include previous AMI or coronary artery bypass surgery, electrocardiographic evidence of bundle branch block, undetermined culprit site by coronary angiography, or first electrocardiogram obtained more than 12 hours after the onset of symptoms. Patient's demographic variables, important risk factors and clinical outcomes including atrioventricular block, arrhythmia, shock, mortality during the first hospital days are recorded.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Retrospective

入排标准

年龄范围
40 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • first attacked acute inferior MI patients

排除标准

  • those with 1). previous AMI, 2). coronary artery bypass surgery, 3). electrocardiographic evidence of bundle branch block, 4). undetermined culprit site by coronary angiography, 5) first electrocardiogram obtained more than 12 hours after the onset of symptoms.

结局指标

主要结局

determine which criteria is the best one in predicting the culprit site

时间窗: about 1-2 months

using ROC curve analysis in the final comparison

次要结局

未报告次要终点

研究者

发起方
Yuan's General Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Shoa-Lin Lin

attending Physician

Yuan's General Hospital

研究点 (1)

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