Impact of Traditional Chinese Medicine on the Gut Microbiota-dependent Trimethylamine N-oxide

Not Applicable

• Conditions: Acute Coronary Syndrome
• Interventions: Drug: Compound Panax Notoginseng Granule; Drug: Placebo Granule

• Registration Number: NCT03186625
• Lead Sponsor: Guangdong Provincial Hospital of Traditional Chinese Medicine

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-06-07
• Study First Submitted QC: 2017-06-13
• Study First Posted: 2017-06-14
• Status Verified: 2017-12
• Study Start: 2017-12-05
• Last Update Submitted: 2017-12-05
• Last Update Posted: 2017-12-07
• Primary Completion: 2018-05-31
• Study Completion: 2018-08-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

1. acute coronary syndrome (ACS), including ST segment elevate myocardial infarction(STEMI), Non-ST-segment elevation myocardial infarction(NSTEMI) and unstable angina(UA).
2. TCM syndrome: Intermingled Phlegm and Blood Stasis.
3. Aged 18 to 80 years old.
4. sign a consent form.

Exclusion Criteria

1. Cardiogenic shock.
2. Serious heart failure (NYHA IV or LVEF < 40%).
3. With severe valvular heart disease.
4. 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.
5. With acute cerebrovascular disease or severe mental illness.
6. With active bleeding or severe hematopoietic system disease.
7. With malignant tumor or life expectancy in less than three years.
8. Pregnancy or ready to pregnant women, nursing mothers.
9. History of taking antibiotics within the past two months.
10. Participating in other clinical subjects .
11. Failure to sign a consent form.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Compound Panax Notoginseng Granule	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.
Placebo Granule	Placebo Granule	On the basis of the standard treatment for ACS,eligible participants are randomized to receive Placebo Granule when they enroll.

Primary Outcome Measures

Name	Time	Method
the plasma level of TMAO	90-days post-procedure	Trimethylamine-N-Oxide(μM) is relative to the prognostic of ACS.

Secondary Outcome Measures

Name	Time	Method
major adverse cardiac event	90-days post-procedure	frequency of the reported cardiovascular events (defined as death, non fatal myocardial infarction,target vessel revascularization and stent thrombosis )
metagenomic DNA sequencing analysis of faecal microbiome	90-days post-procedure	high-throughput sequencing and big data analytics
cardiac function	90-day at follow-up	left ventricular ejection fraction(LVEF) evaluated by echo
Seattle Angina Questionnaire score	90-days	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).
The traditional Chinese medicine syndrome scale	change from baseline at 90-days	The score of phlegm and of blood stasis syndromes is evaluated by Phlegm and blood stasis syndrome questionnaire.
platelet function	change from Baseline at 90-days	maximal aggregation rate of platelet in percent
cardiac biomarkers of necrosis	Change from Baseline at 5 days	cardiac troponin T (cTnT) in ug/L
lipid metabolism	change from baseline at 90-days	total cholesterol in cholesterol in mmol/L
inflammatory factors	change from baseline at 90-days	C-reactive protein in mg/L

Trial Locations

Locations (1)

Guangdong Provincial Hospital of Chinese Medicine; 🇨🇳 Guangzhou, Guangdong, China