- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02850627
The Effect of Tongguan Capsule for MicroRNA Profiles in Coronary Heart Disease Patients
July 31, 2016 updated by: Huizheng Zhu, Guangdong Provincial Hospital of Traditional Chinese Medicine
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
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.
Study Overview
Status
Unknown
Intervention / Treatment
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
Study Type
Interventional
Enrollment (Anticipated)
100
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Huizheng Zhu, PHD
- Phone Number: 32808 86-20-81887233
- Email: 754357604@qq.com
Study Locations
-
-
Guangdong
-
GuangZhou, Guangdong, China
- Recruiting
- Department of Critical Care Medicine, Guangdong Provincial Hospital of Chinese Medicine
-
Contact:
- Minzhou Zhang, MD
- Phone Number: 32808 86-20-81887233
- Email: 1542377671@qq.com
-
Principal Investigator:
- Huizheng Zhu, PhD
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
35 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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
- Postoperative routine drug treatment
- Traditional Chinese Medicine syndrome differentiation of qi -deficiency and qi -stagnation blood stasis or blood stasis license
- Aged 35 to 75 years old
- Must sign a consent form.
Exclusion Criteria:
- Renal insufficiency, the male serum creatinine > 2.5 mg/dl (> 220 umo/l), women > 2.0 mg/dl (> 175 umo/l)
- With obvious liver disease or Alanine aminotransferase ( ALT), Aspartate aminotransferase ( AST), 3 times higher than normal ceiling
- Serious cardiac insufficiency (EF < 35%)
- Uncontrolled patients with high blood pressure
- Merger or severe valvular heart disease in acute cerebrovascular disease
- Random blood glucose or greater tendency for 13.7 / L diabetes or glycosylated hemoglobin 9.5% or more
- Patients with severe mental illness
- Patients with malignant tumor or life expectancy in less than three years
- Patients with severe hematopoietic system disease
- Refused to sign a consent form, or estimated compliance is poorer, follow-up possibilities claim;
- Pregnancy or ready to pregnant women, nursing mothers;
- Participated in nearly three months, or is in other clinical subjects . -
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Tongguan capsule
Tongguan capsule (0.5 g tid.
for 6 months)
|
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)
|
eligible participants were randomized to receive placebo capsule ( 1.5 g/day for six months immediately after PCI)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
six months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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)
|
six months
|
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
|
6 months
|
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
|
6 months
|
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.
|
6 months
|
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 months
|
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
|
6 months
|
Echocardiography measure of left ventricular systolic function
Time Frame: 6 months
|
Evaluation of left ventricular systolic function by left ventricular ejection fraction( LVEF) (%)
|
6 months
|
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
|
6 months
|
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.
|
6 months
|
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. |
6 months
|
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).
|
6 months
|
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
|
6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- 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
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2016
Primary Completion (Anticipated)
September 1, 2017
Study Completion (Anticipated)
December 1, 2017
Study Registration Dates
First Submitted
July 21, 2016
First Submitted That Met QC Criteria
July 27, 2016
First Posted (Estimate)
August 1, 2016
Study Record Updates
Last Update Posted (Estimate)
August 2, 2016
Last Update Submitted That Met QC Criteria
July 31, 2016
Last Verified
July 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- B2015-129-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Yes
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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