Study on Therapeutic Effect of Treating Mental Stress Induced Myocardial Ischemia

Not Applicable

• Conditions: Theraphy of Chinese Traditional Medicine
• Interventions: Drug: Xinkeshu tablets; Other: placebo

• Registration Number: NCT02135250
• Lead Sponsor: Meiyan Liu

Brief Summary

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

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.

Study Timeline

• Study Start: 2014-01
• Study First Submitted: 2014-05-06
• Study First Submitted QC: 2014-05-08
• Study First Posted: 2014-05-09
• Status Verified: 2015-01
• Last Update Submitted: 2015-01-26
• Last Update Posted: 2015-01-27
• Primary Completion: 2015-07
• Study Completion: 2015-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

1. above 18 years old,
2. having coronary stenosis (> 70%) measured by coronary arteriography,
3. with medical history of myocardial infarction or revascularization procedures,
4. or with sufficient proof for having CHD.

Exclusion Criteria

1. patient age younger than 18,
2. clearly impaired cognitive function,
3. damage of functions of vital organs,
4. suicidal ideation,
5. mental diseases treated with selective serotonin reuptake inhibitor (SSRI)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Xinkeshu tablet	Xinkeshu tablets	4 Xinkeshu tablets are given three times per day
placebo	placebo	the placebo is not drug

Primary Outcome Measures

Name	Time	Method
Left ventricular ejection fraction	up to 8 weeks	reduction of LVEF by 5% or more
ventricular wall motion	up to 8 weeks	Echocardiography to assess the ventricular wall motion in one cardiac cycle starting from the systole

Trial Locations

Locations (1)

Beijing Anzhen Hospital; 🇨🇳 Beijing, Beijing, China