Clinical trial NCT02850627: The Effect of Tongguan Capsule for MicroRNA Profiles in Coronary Heart Disease Patients
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 type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Coronary Heart Disease
Acute Myocardial Infarction
Keywords: acute coronary syndrome
Tongguan capsule
miRNAs
Lead sponsor: Guangdong Provincial Hospital of Traditional Chinese Medicine
Sponsor class: OTHER
First posted: 2016-08-01
Enrollment: 100
Sex: ALL
Minimum age (years): 35
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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 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

Eligibility 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 . -

Primary outcomes:
measure: miRNAs spectrum
timeFrame: six months
Secondary outcomes:
measure: major adverse cardiac event
timeFrame: six months
measure: Renin predicts cardiovascular homeostasis and ventricular remodeling
timeFrame: 6 months
measure: Ang II predicts cardiovascular homeostasis and ventricular remodeling
timeFrame: 6 months
measure: Serum E
timeFrame: 6 months
measure: Inflammatory mediators
timeFrame: 6 months
measure: Brain Natriuretic Peptide
timeFrame: 6 months
measure: Echocardiography measure of left ventricular systolic function
timeFrame: 6 months
measure: Echocardiography measure of left ventricular diastolic function
timeFrame: 6 months
measure: New York Heart Association functional classification
timeFrame: 6 months
measure: Coronary angiography
timeFrame: 6 months
measure: Seattle Angina Questionnaire score
timeFrame: 6 months
measure: The traditional Chinese medicine syndrome scale
timeFrame: 6 months
Other outcomes:
Locations:
city: GuangZhou
country: China
facility: Department of Critical Care Medicine, Guangdong Provincial Hospital of Chinese Medicine
state: Guangdong
Study officials:
affiliation: Department of Critical Care Medicine, Guangdong Provincial Hospital of Chinese Medicine
name: Minzhou Zhang, MD
role: STUDY_DIRECTOR
affiliation: Department of Critical Care Medicine, Guangdong Provincial Hospital of Chinese Medicine
name: Huizheng Zhu, PhD
role: PRINCIPAL_INVESTIGATOR
References: