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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
80
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.
Placebo granule has the same as Compound Panax Notoginseng Granule in the appearance, shape,colour,taste,frequency and duration.
Guangdong Provincial Hospital of Chinese Medicine
Guangzhou, Guangdong, China
RECRUITINGthe plasma level of TMAO
Trimethylamine-N-Oxide(μM) is relative to the prognostic of ACS.
Time frame: baseline
the plasma level of TMAO
Trimethylamine-N-Oxide(μM) is relative to the prognostic of ACS.
Time frame: 90-days post-procedure
metagenomic DNA sequencing analysis of faecal microbiome
high-throughput sequencing and big data analytics
Time frame: baseline
metagenomic DNA sequencing analysis of faecal microbiome
high-throughput sequencing and big data analytics
Time frame: 90-days post-procedure
major adverse cardiac event
frequency of the reported cardiovascular events (defined as death, non fatal myocardial infarction,target vessel revascularization and stent thrombosis )
Time frame: 90-days post-procedure
cardiac function
left ventricular ejection fraction(LVEF) evaluated by echo
Time frame: baseline
cardiac function
left ventricular ejection fraction(LVEF) evaluated by echo
Time frame: 90-day at follow-up
Seattle Angina Questionnaire score
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).
Time frame: 90-days
The traditional Chinese medicine syndrome scale
The score of phlegm and of blood stasis syndromes is evaluated by Phlegm and blood stasis syndrome questionnaire.
Time frame: change from baseline at 90-days
lipid metabolism
low-density lipoprote in cholesterol in mmol/L
Time frame: change from baseline at 90-days
lipid metabolism
total cholesterol in cholesterol in mmol/L
Time frame: change from baseline at 90-days
inflammatory factors
C-reactive protein in mg/L
Time frame: change from baseline at 90-days
platelet function
maximal aggregation rate of platelet in percent
Time frame: change from Baseline at 90-days
cardiac biomarkers of necrosis
cardiac troponin T (cTnT) in ug/L
Time frame: Change from Baseline at 5 days
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