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Study on Therapeutic Effect of Treating Mental Stress Induced Myocardial Ischemia

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ClinicalTrials.gov Identifier: NCT02135250
Recruitment Status : Unknown
Verified January 2015 by Meiyan Liu, Beijing Anzhen Hospital.
Recruitment status was:  Recruiting
First Posted : May 9, 2014
Last Update Posted : January 27, 2015
Sponsor:
Information provided by (Responsible Party):
Meiyan Liu, Beijing Anzhen Hospital

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.

Condition or disease Intervention/treatment Phase
Theraphy of Chinese Traditional Medicine Drug: Xinkeshu tablets Other: placebo Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
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 Start Date : January 2014
Estimated Primary Completion Date : July 2015
Estimated Study Completion Date : December 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: placebo
the placebo is not drug
Other: placebo
the placebo is not drug.

Experimental: Xinkeshu tablet
4 Xinkeshu tablets are given three times per day
Drug: Xinkeshu tablets
4 Xinkeshu tablets are given three times per day




Primary Outcome Measures :
  1. Left ventricular ejection fraction [ Time Frame: up to 8 weeks ]
    reduction of LVEF by 5% or more

  2. ventricular wall motion [ Time Frame: up to 8 weeks ]
    Echocardiography to assess the ventricular wall motion in one cardiac cycle starting from the systole



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02135250


Contacts
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Contact: Liu Meiyan 13001241364 ext 86 zhanglijun0411@126.com

Locations
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China, Beijing
Beijing Anzhen Hospital Recruiting
Beijing, Beijing, China, 100029
Contact: Liu Meiyan    13001241364 ext 86    zhanglijun0411@126.com   
Principal Investigator: Liu Meiyan         
Sponsors and Collaborators
Meiyan Liu
Investigators
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Principal Investigator: Anzhen Beijing Capital Medical University
Publications:

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Responsible Party: Meiyan Liu, physician, Beijing Anzhen Hospital
ClinicalTrials.gov Identifier: NCT02135250    
Other Study ID Numbers: 2013022
First Posted: May 9, 2014    Key Record Dates
Last Update Posted: January 27, 2015
Last Verified: January 2015
Keywords provided by Meiyan Liu, Beijing Anzhen Hospital:
Traditional Chinese Medicine
Additional relevant MeSH terms:
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Myocardial Ischemia
Coronary Artery Disease
Ischemia
Stress, Psychological
Pathologic Processes
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Coronary Disease
Arteriosclerosis
Arterial Occlusive Diseases
Behavioral Symptoms