Impact of Traditional Chinese Medicine on the Gut Microbiota-dependent Trimethylamine N-oxide in Acute Coronary Syndromes : A Randomized Placebo Controlled Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- the plasma level of TMAO
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: Compound Panax Notoginseng Granule (Drug)
Placebo Granule
On the basis of the standard treatment for ACS,eligible participants are randomized to receive Placebo Granule when they enroll.
干预措施: Placebo Granule (Drug)
结局指标
主要结局
the plasma level of TMAO
时间窗: 90-days post-procedure
Trimethylamine-N-Oxide(μM) is relative to the prognostic of ACS.
次要结局
- major adverse cardiac event(90-days post-procedure)
- metagenomic DNA sequencing analysis of faecal microbiome(90-days post-procedure)
- cardiac function(90-day at follow-up)
- Seattle Angina Questionnaire score(90-days)
- The traditional Chinese medicine syndrome scale(change from baseline at 90-days)
- platelet function(change from Baseline at 90-days)
- cardiac biomarkers of necrosis(Change from Baseline at 5 days)
- lipid metabolism(change from baseline at 90-days)
- inflammatory factors(change from baseline at 90-days)
研究者
Lei Wang
Associate Chief Physician
Guangdong Provincial Hospital of Traditional Chinese Medicine