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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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 Percu

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.

Detailed Summary: 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
Sponsor: Guangdong Provincial Hospital of Traditional Chinese Medicine

Current Primary Outcome: miRNAs spectrum [ Time Frame: six months ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

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

• 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).
• 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

Original Secondary Outcome:

• 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)
• Renin [ Time Frame: 6 months ]
  renin（ng/ml） predicts cardiovascular homeostasis and blood pressure maintenance and plays an important role in ventricular remodeling
• Ang II [ Time Frame: 6 months ]
  Ang II（pg/ml） predicts cardiovascular homeostasis and blood pressure maintenance and plays an important role in ventricular remodeling
• 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.
• 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
• 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
• Echocardiography measure of left ventricular systolic function [ Time Frame: 6 months ]
  Evaluation of left ventricular systolic function by left ventricular ejection fraction( LVEF) (%)
• 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
• 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.
• 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.

• 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).
• 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

Dates:
Date Received: July 21, 2016
Date Started: July 2016
Date Completion: December 2017
Last Updated: July 31, 2016
Last Verified: July 2016