Study on Therapeutic Effect of Treating Mental Stress Induced Myocardial Ischemia
NCT ID: NCT02135250
Last Updated: 2015-01-27
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
UNKNOWN
Clinical Phase
NA
Total Enrollment
120 participants
Study Classification
INTERVENTIONAL
Study Start Date
2014-01-31
Study Completion Date
2015-12-31
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.
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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.
Conditions
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Theraphy of Chinese Traditional Medicine
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Primary Study Purpose
TREATMENT
Blinding Strategy
DOUBLE
Participants
Caregivers
Study Groups
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placebo
the placebo is not drug
Group Type
EXPERIMENTAL
placebo
Intervention Type
OTHER
the placebo is not drug.
Xinkeshu tablet
4 Xinkeshu tablets are given three times per day
Group Type
EXPERIMENTAL
Xinkeshu tablets
Intervention Type
DRUG
4 Xinkeshu tablets are given three times per day
Interventions
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Xinkeshu tablets
4 Xinkeshu tablets are given three times per day
Intervention Type
DRUG
placebo
the placebo is not drug.
Intervention Type
OTHER
Eligibility Criteria
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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.
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)
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)
Minimum Eligible Age
18 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Meiyan Liu
OTHER
Sponsor Role
lead
Responsible Party
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Meiyan Liu
physician
Responsibility Role
SPONSOR_INVESTIGATOR
Principal Investigators
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Anzhen Beijing
Role: PRINCIPAL_INVESTIGATOR
Capital Medical University
Locations
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Beijing Anzhen Hospital
Beijing, Beijing Municipality, China
Site Status
RECRUITING
Countries
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China
Central Contacts
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Facility Contacts
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References
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Faxon DP, Creager MA, Smith SC Jr, Pasternak RC, Olin JW, Bettmann MA, Criqui MH, Milani RV, Loscalzo J, Kaufman JA, Jones DW, Pearce WH; American Heart Association. Atherosclerotic Vascular Disease Conference: Executive summary: Atherosclerotic Vascular Disease Conference proceeding for healthcare professionals from a special writing group of the American Heart Association. Circulation. 2004 Jun 1;109(21):2595-604. doi: 10.1161/01.CIR.0000128517.52533.DB. No abstract available.
Reference Type
BACKGROUND
Strike PC, Steptoe A. Systematic review of mental stress-induced myocardial ischaemia. Eur Heart J. 2003 Apr;24(8):690-703. doi: 10.1016/s0195-668x(02)00615-2. No abstract available.
Reference Type
BACKGROUND
Jiang W, Babyak M, Krantz DS, Waugh RA, Coleman RE, Hanson MM, Frid DJ, McNulty S, Morris JJ, O'Connor CM, Blumenthal JA. Mental stress--induced myocardial ischemia and cardiac events. JAMA. 1996 Jun 5;275(21):1651-6. doi: 10.1001/jama.275.21.1651.
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Other Identifiers
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2013022
Identifier Type: -
Identifier Source: org_study_id
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