search
Back to results

Study on Therapeutic Effect of Treating Mental Stress Induced Myocardial Ischemia

Primary Purpose

Theraphy of Chinese Traditional Medicine

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Xinkeshu tablets
placebo
Sponsored by
Meiyan Liu
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Theraphy of Chinese Traditional Medicine focused on measuring Traditional Chinese Medicine

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Beijing Anzhen HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

placebo

Xinkeshu tablet

Arm Description

the placebo is not drug

4 Xinkeshu tablets are given three times per day

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
May 6, 2014
Last Updated
January 26, 2015
Sponsor
Meiyan Liu
search

1. Study Identification

Unique Protocol Identification Number
NCT02135250
Brief Title
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

2. Study Status

Record Verification Date
January 2015
Overall Recruitment Status
Unknown status
Study Start Date
January 2014 (undefined)
Primary Completion Date
July 2015 (Anticipated)
Study Completion Date
December 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Meiyan Liu

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Theraphy of Chinese Traditional Medicine
Keywords
Traditional Chinese Medicine

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
placebo
Arm Type
Experimental
Arm Description
the placebo is not drug
Arm Title
Xinkeshu tablet
Arm Type
Experimental
Arm Description
4 Xinkeshu tablets are given three times per day
Intervention Type
Drug
Intervention Name(s)
Xinkeshu tablets
Intervention Description
4 Xinkeshu tablets are given three times per day
Intervention Type
Other
Intervention Name(s)
placebo
Intervention Description
the placebo is not drug.
Primary Outcome Measure Information:
Title
Left ventricular ejection fraction
Description
reduction of LVEF by 5% or more
Time Frame
up to 8 weeks
Title
ventricular wall motion
Description
Echocardiography to assess the ventricular wall motion in one cardiac cycle starting from the systole
Time Frame
up to 8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Liu Meiyan
Phone
13001241364
Ext
86
Email
zhanglijun0411@126.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anzhen Beijing
Organizational Affiliation
Capital Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Beijing Anzhen Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100029
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Liu Meiyan
Phone
13001241364
Ext
86
Email
zhanglijun0411@126.com
First Name & Middle Initial & Last Name & Degree
Liu Meiyan

12. IPD Sharing Statement

Citations:
PubMed Identifier
15173041
Citation
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.
Results Reference
background
PubMed Identifier
12713764
Citation
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.
Results Reference
background
PubMed Identifier
8637138
Citation
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.
Results Reference
background
PubMed Identifier
11956119
Citation
Sheps DS, McMahon RP, Becker L, Carney RM, Freedland KE, Cohen JD, Sheffield D, Goldberg AD, Ketterer MW, Pepine CJ, Raczynski JM, Light K, Krantz DS, Stone PH, Knatterud GL, Kaufmann PG. Mental stress-induced ischemia and all-cause mortality in patients with coronary artery disease: Results from the Psychophysiological Investigations of Myocardial Ischemia study. Circulation. 2002 Apr 16;105(15):1780-4. doi: 10.1161/01.cir.0000014491.90666.06.
Results Reference
background
PubMed Identifier
25395310
Citation
Liu Y, Huang Y, Zhao C, Qin X, Zhu Q, Chen S, Qu J. Salvia miltiorrhiza injection on pulmonary heart disease: a systematic review and meta-analysis. Am J Chin Med. 2014;42(6):1315-31. doi: 10.1142/S0192415X14500827.
Results Reference
background
PubMed Identifier
9812651
Citation
Zhong LY, Shen ZY, Cai DF. [Effect of three kinds (tonifying kidney, invigorating spleen, promoting blood circulation) recipes on the hypothalamus-pituitary-adrenal-thymus (HPAT) axis and CRF gene expression]. Zhongguo Zhong Xi Yi Jie He Za Zhi. 1997 Jan;17(1):39-41. Chinese.
Results Reference
background
PubMed Identifier
25446591
Citation
Gao Y, Zhang K, Zhu F, Wu Z, Chu X, Zhang X, Zhang Y, Zhang J, Chu L. Salvia miltiorrhiza (Danshen) inhibits L-type calcium current and attenuates calcium transient and contractility in rat ventricular myocytes. J Ethnopharmacol. 2014 Dec 2;158 Pt A:397-403. doi: 10.1016/j.jep.2014.10.049. Epub 2014 Oct 31.
Results Reference
background
PubMed Identifier
24980468
Citation
Maji AK, Pandit S, Banerji P, Banerjee D. Pueraria tuberosa: a review on its phytochemical and therapeutic potential. Nat Prod Res. 2014;28(23):2111-27. doi: 10.1080/14786419.2014.928291. Epub 2014 Jul 1.
Results Reference
background
PubMed Identifier
25523598
Citation
Zhao S, Zheng MX, Chen HE, Wu CY, Wang WT. Effect of panax notoginseng saponins injection on the p38MAPK pathway in lung tissue in a rat model of hypoxic pulmonary hypertension. Chin J Integr Med. 2015 Feb;21(2):147-51. doi: 10.1007/s11655-014-1790-2. Epub 2014 Dec 19.
Results Reference
background
PubMed Identifier
25482678
Citation
Huang SS, Deng JS, Lin JG, Lee CY, Huang GJ. Anti-inflammatory effects of trilinolein from Panax notoginseng through the suppression of NF-kappaB and MAPK expression and proinflammatory cytokine expression. Am J Chin Med. 2014;42(6):1485-506. doi: 10.1142/S0192415X14500931.
Results Reference
background
PubMed Identifier
25478513
Citation
Ghanbari-Niaki A, Ghanbari-Abarghooi S, Rahbarizadeh F, Zare-Kookandeh N, Gholizadeh M, Roudbari F, Zare-Kookandeh A. Heart ABCA1 and PPAR- alpha Genes Expression Responses in Male rats: Effects of High Intensity Treadmill Running Training and Aqueous Extraction of Black Crataegus-Pentaegyna. Res Cardiovasc Med. 2013 Nov;2(4):153-9. doi: 10.5812/cardiovascmed.13892. Epub 2013 Oct 28.
Results Reference
background
PubMed Identifier
22740739
Citation
Coulter SA, Campos K. Identify and treat depression for reduced cardiac risk and improved outcomes. Tex Heart Inst J. 2012;39(2):231-4.
Results Reference
background
PubMed Identifier
8921780
Citation
Goldberg AD, Becker LC, Bonsall R, Cohen JD, Ketterer MW, Kaufman PG, Krantz DS, Light KC, McMahon RP, Noreuil T, Pepine CJ, Raczynski J, Stone PH, Strother D, Taylor H, Sheps DS. Ischemic, hemodynamic, and neurohormonal responses to mental and exercise stress. Experience from the Psychophysiological Investigations of Myocardial Ischemia Study (PIMI). Circulation. 1996 Nov 15;94(10):2402-9. doi: 10.1161/01.cir.94.10.2402.
Results Reference
background
PubMed Identifier
9581726
Citation
Jain D, Shaker SM, Burg M, Wackers FJ, Soufer R, Zaret BL. Effects of mental stress on left ventricular and peripheral vascular performance in patients with coronary artery disease. J Am Coll Cardiol. 1998 May;31(6):1314-22. doi: 10.1016/s0735-1097(98)00092-8.
Results Reference
background
PubMed Identifier
11300447
Citation
Kop WJ, Krantz DS, Howell RH, Ferguson MA, Papademetriou V, Lu D, Popma JJ, Quigley JF, Vernalis M, Gottdiener JS. Effects of mental stress on coronary epicardial vasomotion and flow velocity in coronary artery disease: relationship with hemodynamic stress responses. J Am Coll Cardiol. 2001 Apr;37(5):1359-66. doi: 10.1016/s0735-1097(01)01136-6.
Results Reference
background
PubMed Identifier
10666065
Citation
Schoder H, Silverman DH, Campisi R, Sayre JW, Phelps ME, Schelbert HR, Czernin J. Regulation of myocardial blood flow response to mental stress in healthy individuals. Am J Physiol Heart Circ Physiol. 2000 Feb;278(2):H360-6. doi: 10.1152/ajpheart.2000.278.2.H360.
Results Reference
background
PubMed Identifier
10647599
Citation
Schoder H, Silverman DH, Campisi R, Karpman H, Phelps ME, Schelbert HR, Czernin J. Effect of mental stress on myocardial blood flow and vasomotion in patients with coronary artery disease. J Nucl Med. 2000 Jan;41(1):11-6.
Results Reference
background
PubMed Identifier
7563456
Citation
Boushey CJ, Beresford SA, Omenn GS, Motulsky AG. A quantitative assessment of plasma homocysteine as a risk factor for vascular disease. Probable benefits of increasing folic acid intakes. JAMA. 1995 Oct 4;274(13):1049-57. doi: 10.1001/jama.1995.03530130055028.
Results Reference
background
PubMed Identifier
10736298
Citation
Woo KS, Sanderson JE, Sun YY, Chook P, Cheung AS, Chan LT, Metreweli C, Lolin YI, Celermajer DS. Hyperhomocyst(e)inemia is a risk factor for arterial endothelial dysfunction in humans. Circulation. 2000 Mar 28;101(12):E116. doi: 10.1161/01.cir.101.12.e116. No abstract available.
Results Reference
background
PubMed Identifier
12423319
Citation
Laaksonen R, Janatuinen T, Vesalainen R, Lehtimaki T, Elovaara I, Jaakkola O, Jokela H, Laakso J, Nuutila P, Punnonen K, Raitakari O, Saikku P, Salminen K, Knuuti J. High oxidized LDL and elevated plasma homocysteine contribute to the early reduction of myocardial flow reserve in healthy adults. Eur J Clin Invest. 2002 Nov;32(11):795-802. doi: 10.1046/j.1365-2362.2002.01051.x.
Results Reference
background
PubMed Identifier
17384331
Citation
Morrow DA, Cannon CP, Jesse RL, Newby LK, Ravkilde J, Storrow AB, Wu AH, Christenson RH; National Academy of Clinical Biochemistry. National Academy of Clinical Biochemistry Laboratory Medicine Practice Guidelines: Clinical characteristics and utilization of biochemical markers in acute coronary syndromes. Circulation. 2007 Apr 3;115(13):e356-75. doi: 10.1161/CIRCULATIONAHA.107.182882. Epub 2007 Mar 23. No abstract available.
Results Reference
background
PubMed Identifier
21139111
Citation
de Lemos JA, Drazner MH, Omland T, Ayers CR, Khera A, Rohatgi A, Hashim I, Berry JD, Das SR, Morrow DA, McGuire DK. Association of troponin T detected with a highly sensitive assay and cardiac structure and mortality risk in the general population. JAMA. 2010 Dec 8;304(22):2503-12. doi: 10.1001/jama.2010.1768. Erratum In: JAMA. 2011 Mar 23;305(12):1200.
Results Reference
background
PubMed Identifier
19347578
Citation
Bass A, Patterson JH, Adams KF Jr. Perspective on the clinical application of troponin in heart failure and states of cardiac injury. Heart Fail Rev. 2010 Jul;15(4):305-17. doi: 10.1007/s10741-008-9124-8. Epub 2009 Apr 5.
Results Reference
background

Learn more about this trial

Study on Therapeutic Effect of Treating Mental Stress Induced Myocardial Ischemia

We'll reach out to this number within 24 hrs