The Effect of Tongguan Capsule for MicroRNA Profiles in Coronary Heart Disease Patients
2016년 7월 31일 업데이트: 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.
연구 개요
상세 설명
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
연구 유형
중재적
등록 (예상)
100
단계
- 4단계
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Guangdong
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GuangZhou, Guangdong, 중국
- 모병
- Department of Critical Care Medicine, Guangdong Provincial Hospital of Chinese Medicine
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연락하다:
- Minzhou Zhang, MD
- 전화번호: 32808 86-20-81887233
- 이메일: 1542377671@qq.com
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수석 연구원:
- Huizheng Zhu, PhD
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
35년 (성인, 고령자)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
모두
설명
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 . -
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 더블
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: Tongguan capsule
Tongguan capsule (0.5 g tid.
for 6 months)
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eligible participants were randomized to receive Tongguan capsule ( 1.5 g/day for six months immediately after PCI)
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위약 비교기: placebo capsule
same volume/day of placebo capsule (0.5 g tid.
for 6 months)
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eligible participants were randomized to receive placebo capsule ( 1.5 g/day for six months immediately after PCI)
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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miRNAs spectrum
기간: 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
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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major adverse cardiac event
기간: six months
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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)
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six months
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Renin predicts cardiovascular homeostasis and ventricular remodeling
기간: 6 months
|
renin（ng/ml） predicts cardiovascular homeostasis and blood pressure maintenance and plays an important role in ventricular remodeling
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6 months
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Ang II predicts cardiovascular homeostasis and ventricular remodeling
기간: 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
기간: 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
|
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Inflammatory mediators
기간: 6 months
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Tumor Necrosis factor alpha (ng/L)and Interleukin-6，IL-6 (ng/L) measure of the general situation of patients
|
6 months
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Brain Natriuretic Peptide
기간: 6 months
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B-type natriuretic peptide（pg/ml） is a neurohormone synthesized in the cardiac ventricles upon ventricular pressure overload and ventricular dilatation
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6 months
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Echocardiography measure of left ventricular systolic function
기간: 6 months
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Evaluation of left ventricular systolic function by left ventricular ejection fraction( LVEF) (%)
|
6 months
|
|
Echocardiography measure of left ventricular diastolic function
기간: 6 months
|
Left ventricular end diastolic diameter (LVEDD) (mm )measure of left ventricular diastolic function in patients
|
6 months
|
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New York Heart Association functional classification
기간: 6 months
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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.
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6 months
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Coronary angiography
기간: 6 months
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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
|
|
시애틀 협심증 설문지 점수
기간: 6 개월
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시애틀 협심증 설문지는 관상동맥질환 환자의 건강에 있어 임상적으로 중요한 다섯 가지 차원(신체적 제한, 협심증 안정성, 협심증 빈도, 치료 만족도 및 질병 인식)을 측정하는 타당하고 신뢰할 수 있는 도구입니다.
(저울의 단위).
|
6 개월
|
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The traditional Chinese medicine syndrome scale
기간: 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
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6 months
|
공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 연구 책임자: Minzhou Zhang, MD, Department of Critical Care Medicine, Guangdong Provincial Hospital of Chinese Medicine
- 수석 연구원: Huizheng Zhu, PhD, Department of Critical Care Medicine, Guangdong Provincial Hospital of Chinese Medicine
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작
2016년 7월 1일
기본 완료 (예상)
2017년 9월 1일
연구 완료 (예상)
2017년 12월 1일
연구 등록 날짜
최초 제출
2016년 7월 21일
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2016년 7월 27일
처음 게시됨 (추정)
2016년 8월 1일
연구 기록 업데이트
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2016년 8월 2일
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추가 정보
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