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

Acute Myocardial Infarction Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02850627
• Other study ID #: B2015-129-01
• Status: Recruiting
• Phase: Phase 4
• First received: July 21, 2016
• Last updated: July 31, 2016
• Start date: July 2016
• Est. completion date: December 2017

Study information

• Verified date: July 2016
• Source: Guangdong Provincial Hospital of Traditional Chinese Medicine
• Contact: Huizheng Zhu, PHD
• Phone: 86-20-81887233
• Email: 754357604[@]qq.com
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 2017
• Est. primary completion date: September 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 35 Years to 75 Years

Eligibility

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 . -

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Acute Myocardial Infarction
• Coronary Artery Disease
• Coronary Disease
• Coronary Heart Disease
• Heart Diseases
• Infarction
• Myocardial Infarction
• Myocardial Ischemia

Intervention

Drug:
• Tongguan capsule
eligible participants were randomized to receive Tongguan capsule ( 1.5 g/day for six months immediately after PCI)
• placebo capsule
eligible participants were randomized to receive placebo capsule ( 1.5 g/day for six months immediately after PCI)

Locations

Country	Name	City	State
China	Department of Critical Care Medicine, Guangdong Provincial Hospital of Chinese Medicine	GuangZhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Guangdong Provincial Hospital of Traditional Chinese Medicine

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	miRNAs spectrum	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.	six months	No
Secondary	major adverse cardiac event	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)	six months	Yes
Secondary	Renin predicts cardiovascular homeostasis and ventricular remodeling	renin(ng/ml) predicts cardiovascular homeostasis and blood pressure maintenance and plays an important role in ventricular remodeling	6 months	No
Secondary	Ang II predicts cardiovascular homeostasis and ventricular remodeling	Ang II(pg/ml) predicts cardiovascular homeostasis and blood pressure maintenance and plays an important role in ventricular remodeling	6 months	No
Secondary	Serum E	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.	6 months	No
Secondary	Inflammatory mediators	Tumor Necrosis factor alpha (ng/L)and Interleukin-6,IL-6 (ng/L) measure of the general situation of patients	6 months	Yes
Secondary	Brain Natriuretic Peptide	B-type natriuretic peptide(pg/ml) is a neurohormone synthesized in the cardiac ventricles upon ventricular pressure overload and ventricular dilatation	6 months	Yes
Secondary	Echocardiography measure of left ventricular systolic function	Evaluation of left ventricular systolic function by left ventricular ejection fraction( LVEF) (%)	6 months	Yes
Secondary	Echocardiography measure of left ventricular diastolic function	Left ventricular end diastolic diameter (LVEDD) (mm )measure of left ventricular diastolic function in patients	6 months	Yes
Secondary	New York Heart Association functional classification	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.	6 months	Yes
Secondary	Coronary angiography	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.	6 months	No
Secondary	Seattle Angina Questionnaire score	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).	6 months	Yes
Secondary	The traditional Chinese medicine syndrome scale	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	6 months	No