Study on Therapeutic Effect of Treating Mental Stress Induced Myocardial Ischemia With Conventional Therapy for Coronary Heart Disease Combined With Traditional Chinese Medicine :Design and Methods
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Left ventricular ejection fraction
研究概览
简要总结
This study aims to discuss whether the combined treatment of traditional Chinese medicine (TCM) and western medicine for Mental Stress Induced Myocardial Ischemia (MSIMI) does effect, namely the conventional therapy for Coronary Heart Disease( CHD) combining with TCM - Xinkeshu tablets.
详细描述
A large number of evidence-based medical researches have proven that bad mood and mental stress are related to poor prognosis. Having recognized that acute emotional stress can induce cardiovascular events, many clinical tests of mental stress have been carried out to observe the correlation between emotional stress and cardiac damage, which ultimately lead to the formalization of the concept of Mental Stress Induced Myocardial Ischemia(MSIMI). In the past 3 decades, it has been evidenced that mental stress is internally related to myocardial ischemia. According to current studies, over 70% patients with stable coronary heart disease have MSIMI and are exposed to three or four times higher risk of cardiovascular events. However, few articles are about the therapeutic effect of MSIMI treatment. This study aims to discuss whether the combined treatment of traditional Chinese medicine (TCM) and western medicine for MSIMI does effect, namely the conventional therapy for CHD combining with TCM - Xinkeshu tablets.
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
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •above 18 years old,
- •having coronary stenosis (> 70%) measured by coronary arteriography,
- •with medical history of myocardial infarction or revascularization procedures,
- •or with sufficient proof for having CHD.
排除标准
- •patient age younger than 18,
- •clearly impaired cognitive function,
- •damage of functions of vital organs,
- •suicidal ideation,
- •mental diseases treated with selective serotonin reuptake inhibitor (SSRI)
研究组 & 干预措施
placebo
the placebo is not drug
干预措施: placebo (Other)
Xinkeshu tablet
4 Xinkeshu tablets are given three times per day
干预措施: Xinkeshu tablets (Drug)
结局指标
主要结局
Left ventricular ejection fraction
时间窗: up to 8 weeks
reduction of LVEF by 5% or more
ventricular wall motion
时间窗: up to 8 weeks
Echocardiography to assess the ventricular wall motion in one cardiac cycle starting from the systole
次要结局
未报告次要终点
研究者
Meiyan Liu
physician
Beijing Anzhen Hospital