NCT02637661Unknown不适用
Earlobe Crease as Risk Factors of Acute Myocardial Infarction in Chinese Population
Jing Qi1 个研究点 分布在 1 个国家目标入组 236 人开始时间: 2015年6月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 236
- 试验地点
- 1
- 主要终点
- Odds ratio(OR，the ratio of the explosure number and non-explosure in case group/ the ratio of the explosure number and non-explosure in control group) and 95% confidence interval were calculated of binaural earlobe crease≥ 7 scores as risk factors of AMI
研究概览
简要总结
The purpose of this study is to explore the earlobe crease as a risk factor of acute myocardial infarction (AMI)in the Chinese population, combined with other risk factors, to predict high risk patients with coronary heart disease.
详细描述
Primary objectives: Odds ratio and 95% confidence interval of binaural earlobe crease as risk factors of AMI.
Secondary objectives:
- To study the characteristics of different earlobe creases in different gender of the patients with AMI.
- To analyze the characteristics of earlobe crease in different age groups.
- To compare the feature of earlobe crease in acute ST elevation myocardial infarction and non ST elevation myocardial infarction.
- The sensitivity,specificity,positive likelihood ratio and negative likelihood ratio of binaural earlobe crease as risk factors of AMI.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Cross Sectional
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Initial acute myocardial infarction(AMI).
- •Detection of a rise and/or fall of cardiac biomarker values (preferably cardiac troponin(cTn) with at least one value above the 99th percentile upper reference limit(URL)) and with at least one of the following:
- •Symptoms of ischemia
- •Development of pathologic Q waves in the electrocardiogram (ECG)
- •New or presumed new significant ST-segment-T wave (ST-T) changes or new left bundle branch block (LBBB).
- •Identification of an intracoronary thrombus by angiography or autopsy
- •Imaging evidence of new loss of viable myocardium or a new regional wall motion abnormality.
- •Type 1 (spontaneous myocardial infarction(MI)) in the third universal definition of MI: MI consequent to a pathologic process in the wall of the coronary artery (eg, plaque erosion/rupture, fissuring, or dissection), resulting in intraluminal thrombus.
- •Infarct related artery (IRA) showed that acute thrombus formation, IRA occlusion or stenosis ≥95%、≥90%～95%、≤90%，thrombolysis in myocardial infarction(TIMI) 0-3 flow.
- •Signed informed consent.
排除标准
- •Combined valvular heart disease, cardiomyopathy, blood diseases, skin diseases, rheumatic diseases, ischemic cerebrovascular disease, tumor, etc.
- •Previous myocardial infarction.
- •Previous percutaneous coronary intervention(PCI) and coronary artery bypass graft(CABG).
- •Chronic total occlusion(CTO)lesions.
- •Ear malformation.
- •Ocular diseases.
- •Participating in a clinical study.
结局指标
主要结局
Odds ratio(OR，the ratio of the explosure number and non-explosure in case group/ the ratio of the explosure number and non-explosure in control group) and 95% confidence interval were calculated of binaural earlobe crease≥ 7 scores as risk factors of AMI
时间窗: 3 years
次要结局
- To compare the score of the ELC in acute ST elevation myocardial infarction and non ST elevation myocardial infarction.(3 years)
- The sensitivity(true positive/true positive+false negative) and specificity(true negative/true negative+false positive) of binaural earlobe crease≥ 7 scores as risk factors of AMI.(3 years)
- The score of ELC in different age groups.(3 years)
- Positive likelihood ratio(+LR，sensitivity/1-speccificity)and negative likelihood ratio(-LR，1-sensitivity/specificity)of binaural earlobe crease≥ 7 scores as risk factors of AMI(3 years)
- The score of the ELC in different gender of the patients with AMI.(3 years)
研究者
Jing Qi
Principal investigator
Liaoning University of Traditional Chinese Medicine
研究点 (1)
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