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
|Condition or disease||Intervention/treatment||Phase|
|Coronary Heart Disease Acute Myocardial Infarction||Drug: Tongguan capsule Drug: placebo capsule||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Investigator, Outcomes Assessor)|
|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|
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)
- 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.
- 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
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
|Contact: Huizheng Zhu, PHD||86-20-81887233 ext firstname.lastname@example.org|
|Department of Critical Care Medicine, Guangdong Provincial Hospital of Chinese Medicine||Recruiting|
|GuangZhou, Guangdong, China|
|Contact: Minzhou Zhang, MD 86-20-81887233 ext 32808 email@example.com|
|Principal Investigator: Huizheng Zhu, PhD|
|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|