Study on Therapeutic Effect of Treating Mental Stress Induced Myocardial Ischemia

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Theraphy of Chinese Traditional Medicine

Intervention / Treatment
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* Drug: Xinkeshu tablets
* Other: placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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)

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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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: placebo<br>the placebo is not drug | Other: placebo<br>* the placebo is not drug.<br>|
| Experimental: Xinkeshu tablet<br>4 Xinkeshu tablets are given three times per day | Drug: Xinkeshu tablets<br>* 4 Xinkeshu tablets are given three times per day<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Left ventricular ejection fraction | reduction of LVEF by 5% or more | up to 8 weeks | 
| ventricular wall motion | Echocardiography to assess the ventricular wall motion in one cardiac cycle starting from the systole | up to 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Traditional Chinese Medicine