Impact of Traditional Chinese Medicine on the Gut Microbiota-dependent Trimethylamine N-oxide (TCM-TMAO)
2017年12月5日 更新者：Lei Wang、Guangdong Provincial Hospital of Traditional Chinese Medicine
Impact of Traditional Chinese Medicine on the Gut Microbiota-dependent Trimethylamine N-oxide in Acute Coronary Syndromes : A Randomized Placebo Controlled Trial
Recent studies highlight the participation of gut microbes in the pathogenesis of both atherosclerotic heart disease and its adverse thrombotic events.
Trimethylamine N-oxide (TMAO) is a plasma metabolite shown to be formed through a metaorganismal pathway involving nutrient precursors abundant in a Western diet and the sequential action of gut microbiota.
Numerous studies reveal an association between systemic TMAO levels and cardiovascular risks in a variety of stable cohorts.
The purpose of this study is to evaluate the efficacy of traditional Chinese Medicine formular (Compound pseudo-ginseng granules ) on the level of TMAO for the patient with acute coronary syndrome(ACS) undergoing percutaneous coronary intervention.
80 patients with ACS would be randomly allocated into interventional group(IG) and control group(CG).
The patients in the IG would be administered by oral Compound pseudo-ginseng granules (twice per day ) for 90 days and those in the CG would receive the placebo twice per day during the same period.
All of subjects would be administered with standard therapy in accordance with AHA/ACC guideline for ST-elevation myocardial infarction(STEMI) and Non ST-elevation myocardial infarction(NSTEMI).The primary endpoint is the plasma level of TMAO at 90-day follow-up.
The second endpoint is the level of lipid, score of The Seattle Angina, fecal DNA extraction and pyrosequencing.
研究概览
研究类型
介入性
注册 (预期的)
80
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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Guangdong
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Guangzhou、Guangdong、中国、510120
- 招聘中
- Guangdong Provincial Hospital of Chinese Medicine
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接触：
- Lei Wang, M.D
- 电话号码：8620-81887233-32801
- 邮箱：Dr.wanglei@139.com
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 至 80年 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- acute coronary syndrome (ACS), including ST segment elevate myocardial infarction(STEMI), Non-ST-segment elevation myocardial infarction(NSTEMI) and unstable angina(UA).
- TCM syndrome: Intermingled Phlegm and Blood Stasis.
- Aged 18 to 80 years old.
- sign a consent form.
Exclusion Criteria:
- Cardiogenic shock.
- Serious heart failure (NYHA IV or LVEF < 40%).
- With severe valvular heart disease.
- Severe hepatic or renal insufficiency, with serum Alanine aminotransferase ( ALT) 3 times higher than normal ceiling or serum creatinine not lower than 265 μmol/L.
- With acute cerebrovascular disease or severe mental illness.
- With active bleeding or severe hematopoietic system disease.
- With malignant tumor or life expectancy in less than three years.
- Pregnancy or ready to pregnant women, nursing mothers.
- History of taking antibiotics within the past two months.
- Participating in other clinical subjects .
- Failure to sign a consent form.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：四人间
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：Compound Panax Notoginseng Granule
On the basis of the standard treatment for ACS,eligible participants are randomized to receive Compound Panax Notoginseng Granule when they enroll.
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Dosage form:granule. Composition: Panax notoginseng,Codonopsis pilosula,Salvia miltiorrhiza,Pinellia ternata,Medicated Leaven,Coptis chinensis,Citrus reticulata Blanco,etc. Frequency:two times a day, one package per time. Duration:three months. |
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安慰剂比较：Placebo Granule
On the basis of the standard treatment for ACS,eligible participants are randomized to receive Placebo Granule when they enroll.
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Placebo granule has the same as Compound Panax Notoginseng Granule in the appearance, shape,colour,taste,frequency and duration.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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the plasma level of TMAO
大体时间：baseline
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Trimethylamine-N-Oxide(μM) is relative to the prognostic of ACS.
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baseline
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the plasma level of TMAO
大体时间：90-days post-procedure
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Trimethylamine-N-Oxide(μM) is relative to the prognostic of ACS.
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90-days post-procedure
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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metagenomic DNA sequencing analysis of faecal microbiome
大体时间：baseline
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high-throughput sequencing and big data analytics
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baseline
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metagenomic DNA sequencing analysis of faecal microbiome
大体时间：90-days post-procedure
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high-throughput sequencing and big data analytics
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90-days post-procedure
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major adverse cardiac event
大体时间：90-days post-procedure
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frequency of the reported cardiovascular events (defined as death, non fatal myocardial infarction,target vessel revascularization and stent thrombosis )
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90-days post-procedure
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cardiac function
大体时间：baseline
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left ventricular ejection fraction(LVEF) evaluated by echo
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baseline
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cardiac function
大体时间：90-day at follow-up
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left ventricular ejection fraction(LVEF) evaluated by echo
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90-day at follow-up
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Seattle Angina Questionnaire score
大体时间：90-days
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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).
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90-days
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The traditional Chinese medicine syndrome scale
大体时间：change from baseline at 90-days
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The score of phlegm and of blood stasis syndromes is evaluated by Phlegm and blood stasis syndrome questionnaire.
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change from baseline at 90-days
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lipid metabolism
大体时间：change from baseline at 90-days
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low-density lipoprote in cholesterol in mmol/L
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change from baseline at 90-days
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lipid metabolism
大体时间：change from baseline at 90-days
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total cholesterol in cholesterol in mmol/L
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change from baseline at 90-days
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inflammatory factors
大体时间：change from baseline at 90-days
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C-reactive protein in mg/L
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change from baseline at 90-days
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platelet function
大体时间：change from Baseline at 90-days
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maximal aggregation rate of platelet in percent
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change from Baseline at 90-days
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cardiac biomarkers of necrosis
大体时间：Change from Baseline at 5 days
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cardiac troponin T (cTnT) in ug/L
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Change from Baseline at 5 days
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 研究主任：Xiaoyan Li, Master、Guangdong Provincial Hospital of Traditional Chinese Medicine
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2017年12月5日
初级完成 (预期的)
2018年5月31日
研究完成 (预期的)
2018年8月31日
研究注册日期
首次提交
2017年6月7日
首先提交符合 QC 标准的
2017年6月13日
首次发布 (实际的)
2017年6月14日
研究记录更新
最后更新发布 (实际的)
2017年12月7日
上次提交的符合 QC 标准的更新
2017年12月5日
最后验证
2017年12月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.
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