The Effect of Low-Level Tragus Stimulation on Echocardiographic Parameters in Patients With ST-Segment Elevation Myocardial Infarction - A Single-Centre Randomized Control Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Left Ventricular Ejection Fraction
研究概览
简要总结
The goal of this clinical trial is to learn the effect of low level tragus stimulation (LLTS) on echocardiographic parameter in patient with ST-segment Elevation Myocardial Infarction (STEMI) who undergo primart percutaneous coronary intervention (PPCI). It will also learn about the safety of LLTS in such setting. The main questions, it aims to answer are compared with sham control:
Does LLTS could alter left ventricular ejection fraction in patients with STEMI? Does LLTS could alter wall motion score index in patients with STEMI? Does LLTS could alter diastolic dysfunction in patients with STEMI?
Researchers will compare LLTS to sham LLTS control to see if LLTS have benefit in participants with STEMI participants will divided into two group i.e. treatment group vs control (sham/placebo) group..
Both groups undergo transthoracal echocardiographi examination before and after PPCI..
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
盲法说明
Participant will not know either they include in treatment or control group
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Onset STEMI less than 12 hours
- •Participant agreed to be included in this study
- •Killip class I - II on presentation
- •SBP >90 mmHg and/or MAP >65 mmHg
- •Sinus rhtyhm
排除标准
- •History of myocardial infarction, stroke, heart failure with reduce ejection fraction, chronic total occlussion on prior coronary angiography, chronic kidney disease (eGFR < 30) or on hemodyalisis, malignancy, hematology disease, autoimmune, or other chronic diseases
- •On permanent pacemaker
- •Acute infection
- •Pregnant woman
结局指标
主要结局
Left Ventricular Ejection Fraction
时间窗: Before PPCI, 1 day after PPCI, and 30 days after PPCI
Left Ventricular Ejection Fraction measured by transthoracic echocardiography
次要结局
- Wall Motion Score Index(Before PPCI, 1 day after PPCI, and 30 days after PPCI)
- Diastolic Function(Before PPCI, 1 day after PPCI, and 30 days after PPCI)
研究者
Sodiqur Rifqi
Principal Investigator; Former of Head of Department of Cardiovascular Medicine Faculty of Medicine Universitas Diponegoro
Universitas Diponegoro