Clinical trial NCT02135250: Study on Therapeutic Effect of Treating Mental Stress Induced Myocardial Ischemia
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Theraphy of Chinese Traditional Medicine
Keywords: Traditional Chinese Medicine
Lead sponsor: Beijing Anzhen Hospital
Sponsor class: OTHER
First posted: 2014-05-09
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Left ventricular ejection fraction
timeFrame: up to 8 weeks
measure: ventricular wall motion
timeFrame: up to 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Anzhen Hospital
state: Beijing
Study officials:
affiliation: Capital Medical University
name: Anzhen Beijing
role: PRINCIPAL_INVESTIGATOR
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