Ignite Creation Date:
2025-12-24 @ 4:50 PM
Ignite Modification Date:
2026-01-13 @ 12:38 PM
Study NCT ID:
NCT02135250
Status:
UNKNOWN
Last Update Posted:
2015-01-27
First Post:
2014-05-06
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study on Therapeutic Effect of Treating Mental Stress Induced Myocardial Ischemia
Sponsor:
Organization:
Raw JSON
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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.'}, {'pmid': '12713764', 'type': 'BACKGROUND', '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.'}, {'pmid': '8637138', 'type': 'BACKGROUND', '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. 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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.'}, {'pmid': '25482678', 'type': 'BACKGROUND', '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.'}, {'pmid': '25478513', 'type': 'BACKGROUND', '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.'}, {'pmid': '22740739', 'type': 'BACKGROUND', '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.'}, {'pmid': '8921780', 'type': 'BACKGROUND', '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.'}, {'pmid': '9581726', 'type': 'BACKGROUND', '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. 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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.'}, {'pmid': '7563456', 'type': 'BACKGROUND', '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.'}, {'pmid': '10736298', 'type': 'BACKGROUND', '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.'}, {'pmid': '12423319', 'type': 'BACKGROUND', '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.'}, {'pmid': '17384331', 'type': 'BACKGROUND', '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.'}, {'pmid': '21139111', 'type': 'BACKGROUND', '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.'}, {'pmid': '19347578', 'type': 'BACKGROUND', '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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. above 18 years old,\n2. having coronary stenosis (\\> 70%) measured by coronary arteriography,\n3. with medical history of myocardial infarction or revascularization procedures,\n4. or with sufficient proof for having CHD.\n\nExclusion Criteria:\n\n1. patient age younger than 18,\n2. clearly impaired cognitive function,\n3. damage of functions of vital organs,\n4. suicidal ideation,\n5. mental diseases treated with selective serotonin reuptake inhibitor (SSRI)'}, 'identificationModule': {'nctId': 'NCT02135250', 'briefTitle': 'Study on Therapeutic Effect of Treating Mental Stress Induced Myocardial Ischemia', 'organization': {'class': 'OTHER', 'fullName': 'Beijing Anzhen Hospital'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': '2013022'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'placebo', 'description': 'the placebo is not drug', 'interventionNames': ['Other: placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Xinkeshu tablet', 'description': '4 Xinkeshu tablets are given three times per day', 'interventionNames': ['Drug: Xinkeshu tablets']}], 'interventions': [{'name': 'Xinkeshu tablets', 'type': 'DRUG', 'description': '4 Xinkeshu tablets are given three times per day', 'armGroupLabels': ['Xinkeshu tablet']}, {'name': 'placebo', 'type': 'OTHER', 'description': 'the placebo is not drug.', 'armGroupLabels': ['placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100029', 'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Liu Meiyan', 'role': 'CONTACT', 'email': 'zhanglijun0411@126.com', 'phone': '13001241364', 'phoneExt': '86'}, {'name': 'Liu Meiyan', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Beijing Anzhen Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Liu Meiyan', 'role': 'CONTACT', 'email': 'zhanglijun0411@126.com', 'phone': '13001241364', 'phoneExt': '86'}], 'overallOfficials': [{'name': 'Anzhen Beijing', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Capital Medical University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Meiyan Liu', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'physician', 'investigatorFullName': 'Meiyan Liu', 'investigatorAffiliation': 'Beijing Anzhen Hospital'}}}}