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The Effect of Tongguan Capsule for MicroRNA Profiles in Coronary Heart Disease Patients

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ClinicalTrials.gov Identifier: NCT02850627
Recruitment Status : Unknown
Verified July 2016 by Huizheng Zhu, Guangdong Provincial Hospital of Traditional Chinese Medicine.
Recruitment status was:  Recruiting
First Posted : August 1, 2016
Last Update Posted : August 2, 2016
Sponsor:
Information provided by (Responsible Party):
Huizheng Zhu, Guangdong Provincial Hospital of Traditional Chinese Medicine

Brief Summary:
The purpose of this study is to test the expression of microRNAs related to the syndromes after the intervention of Tongguan capsule,preliminarily to investigate the mechanism of the effects of Tongguan capsule, and provide the biological foundation of curative effect of Tongguan capsule.

Condition or disease Intervention/treatment Phase
Coronary Heart Disease Acute Myocardial Infarction Drug: Tongguan capsule Drug: placebo capsule Phase 4

Detailed Description:
The primary end points is the core of the whole experiment scheme. miRNAs regulate gene expression posttranscriptionally by degrading messenger RNA (mRNA) targets and by blocking their translation Secondary endpoints will include The adverse cardiac clinical events (MACE) in terms of cardiac death,periprocedural myocardial infarction (MI),spontaneous MI and target vessel revascularization(TVR). Related parameters of qi and blood are the material basis of blood conversion and objective performance is used to evaluate the effect on Tongguan capsule on patients with blood stagnation, which can be either interpretation theory of qi deficiency and blood stagnation and mutual transformation between qi and blood can find targets through Tongguan capsule on blood . Routine laboratory tests are used for screening patients basic situation and ensure the safety of the experiment The traditional Chinese medicine syndrome scale Including the the score of deficiency of qi and score of blood stasis syndrome mainly used to identify patients with the traditional Chinese medicine syndrome type Approximately 100 patients in Coronary Heart Disease Patients with Blood Stasis Syndrome undergoing percutaneous coronary intervention will be enrolled and randomized to divided into Qi -stagnation and blood stasis, Qi- deficiency and blood stasis, after the PCI surgery, Qi deficiency and blood stasis group were randomly divided into Tongguan capsule group and the control group, and qi stagnation and blood stasis group, too ,giving patients through Tongguan capsule 3 pills three times a day(1.5g/day), once every three months follow-up, after have been followed up to six months

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: The Effect of Tongguan Capsule for MicroRNA Profiles Between Qi-Stagnation and Qi-Deficiency in Coronary Heart Disease Patients With Blood Stasis Syndrome Undergoing Percutaneous Coronary Intervention
Study Start Date : July 2016
Estimated Primary Completion Date : September 2017
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Tongguan capsule
Tongguan capsule (0.5 g tid. for 6 months)
Drug: Tongguan capsule
eligible participants were randomized to receive Tongguan capsule ( 1.5 g/day for six months immediately after PCI)

Placebo Comparator: placebo capsule
same volume/day of placebo capsule (0.5 g tid. for 6 months)
Drug: placebo capsule
eligible participants were randomized to receive placebo capsule ( 1.5 g/day for six months immediately after PCI)




Primary Outcome Measures :
  1. miRNAs spectrum [ Time Frame: six months ]
    Test the expression of microRNAs related to the syndromes after the intervention of Tongguan capsule,preliminarily to investigate the mechanism of the effects of Tongguan capsule, and provide the biological foundation of curative effect of Tongguan capsule.


Secondary Outcome Measures :
  1. major adverse cardiac event [ Time Frame: six months ]
    frequency of the reported cardiovascular events (defined as cardiogenic death, stroke, recurrent myocardial infarction, readmission on account of deterioration of congestive heart failure or unstable angina, target vessel revascularization)

  2. Renin predicts cardiovascular homeostasis and ventricular remodeling [ Time Frame: 6 months ]
    renin(ng/ml) predicts cardiovascular homeostasis and blood pressure maintenance and plays an important role in ventricular remodeling

  3. Ang II predicts cardiovascular homeostasis and ventricular remodeling [ Time Frame: 6 months ]
    Ang II(pg/ml) predicts cardiovascular homeostasis and blood pressure maintenance and plays an important role in ventricular remodeling

  4. Serum E [ Time Frame: 6 months ]
    Acute coronary syndrome is caused by atherosclerotic plaque instability and rupture. The stability of plaque is closely related to inflammation.Serum E (pmol / L) is an important pathway of various immune and inflammatory regulation, which promotes the development of atherosclerosis and is a risk factor for atherosclerosis.

  5. Inflammatory mediators [ Time Frame: 6 months ]
    Tumor Necrosis factor alpha (ng/L)and Interleukin-6,IL-6 (ng/L) measure of the general situation of patients

  6. Brain Natriuretic Peptide [ Time Frame: 6 months ]
    B-type natriuretic peptide(pg/ml) is a neurohormone synthesized in the cardiac ventricles upon ventricular pressure overload and ventricular dilatation

  7. Echocardiography measure of left ventricular systolic function [ Time Frame: 6 months ]
    Evaluation of left ventricular systolic function by left ventricular ejection fraction( LVEF) (%)

  8. Echocardiography measure of left ventricular diastolic function [ Time Frame: 6 months ]
    Left ventricular end diastolic diameter (LVEDD) (mm )measure of left ventricular diastolic function in patients

  9. New York Heart Association functional classification [ Time Frame: 6 months ]
    I Cardiac disease, but no symptoms and no limitation in ordinary physical activity, e.g. no shortness of breath when walking, climbing stairs etc. II Mild symptoms (mild shortness of breath and/or angina) and slight limitation during ordinary activity. III Marked limitation in activity due to symptoms, even during less-than-ordinary activity, e.g. walking short distances (20-100 m).Comfortable only at rest. IV Severe limitations. Experiences symptoms even while at rest. Mostly bedbound patients.

  10. Coronary angiography [ Time Frame: 6 months ]

    Quantitative coronary angiography in the stenosis degree, 25%, 50%, 75%, 90%, 99%, 100%, 1, 2, 4, 6, 8,, 16, 32, and, respectively.

    Scoring multiplication will segment coefficients corresponding to the degree of stenosis and the stenosis of total score that is the sum of Gensini score of coronary artery stenosis in the patients.


  11. Seattle Angina Questionnaire score [ Time Frame: 6 months ]
    The Seattle Angina Questionnaire is a valid and reliable instrument that measures five clinically important dimensions of health in patients with coronary artery disease (physical limitation, anginal stability, anginal frequency, treatment satisfaction, and disease perception). (in Units on a Scale).

  12. The traditional Chinese medicine syndrome scale [ Time Frame: 6 months ]
    The traditional Chinese medicine syndrome scale Including the the score of deficiency of qi and score of blood stasis syndrome mainly used to identify patients with traditional Chinese medicine syndrome type



Information from the National Library of Medicine

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Ages Eligible for Study:   35 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. In line with the diagnostic criteria for acute coronary syndrome (ACS), coronary angiography confirmed for coronary heart disease (CHD), parallel Percutaneous transluminal coronary angioplasty( PTCA) and/or coronary stent implantation was successful
  2. Postoperative routine drug treatment
  3. Traditional Chinese Medicine syndrome differentiation of qi -deficiency and qi -stagnation blood stasis or blood stasis license
  4. Aged 35 to 75 years old
  5. Must sign a consent form.

Exclusion Criteria:

  1. Renal insufficiency, the male serum creatinine > 2.5 mg/dl (> 220 umo/l), women > 2.0 mg/dl (> 175 umo/l)
  2. With obvious liver disease or Alanine aminotransferase ( ALT), Aspartate aminotransferase ( AST), 3 times higher than normal ceiling
  3. Serious cardiac insufficiency (EF < 35%)
  4. Uncontrolled patients with high blood pressure
  5. Merger or severe valvular heart disease in acute cerebrovascular disease
  6. Random blood glucose or greater tendency for 13.7 / L diabetes or glycosylated hemoglobin 9.5% or more
  7. Patients with severe mental illness
  8. Patients with malignant tumor or life expectancy in less than three years
  9. Patients with severe hematopoietic system disease
  10. Refused to sign a consent form, or estimated compliance is poorer, follow-up possibilities claim;
  11. Pregnancy or ready to pregnant women, nursing mothers;
  12. Participated in nearly three months, or is in other clinical subjects . -

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): NCT02850627


Contacts
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Contact: Huizheng Zhu, PHD 86-20-81887233 ext 32808 754357604@qq.com

Locations
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China, Guangdong
Department of Critical Care Medicine, Guangdong Provincial Hospital of Chinese Medicine Recruiting
GuangZhou, Guangdong, China
Contact: Minzhou Zhang, MD    86-20-81887233 ext 32808    1542377671@qq.com   
Principal Investigator: Huizheng Zhu, PhD         
Sponsors and Collaborators
Guangdong Provincial Hospital of Traditional Chinese Medicine
Investigators
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Study Director: Minzhou Zhang, MD Department of Critical Care Medicine, Guangdong Provincial Hospital of Chinese Medicine
Principal Investigator: Huizheng Zhu, PhD Department of Critical Care Medicine, Guangdong Provincial Hospital of Chinese Medicine

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Responsible Party: Huizheng Zhu, physician, Guangdong Provincial Hospital of Traditional Chinese Medicine
ClinicalTrials.gov Identifier: NCT02850627     History of Changes
Other Study ID Numbers: B2015-129-01
First Posted: August 1, 2016    Key Record Dates
Last Update Posted: August 2, 2016
Last Verified: July 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

Keywords provided by Huizheng Zhu, Guangdong Provincial Hospital of Traditional Chinese Medicine:
acute coronary syndrome
Tongguan capsule
miRNAs

Additional relevant MeSH terms:
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Infarction
Heart Diseases
Myocardial Infarction
Coronary Disease
Coronary Artery Disease
Myocardial Ischemia
Ischemia
Pathologic Processes
Necrosis
Cardiovascular Diseases
Vascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases