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

Acute Coronary Syndrome Clinical Trial

— TCM-TMAO  

Official title:

Impact of Traditional Chinese Medicine on the Gut Microbiota-dependent Trimethylamine N-oxide in Acute Coronary Syndromes : A Randomized Placebo Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03186625
• Other study ID #: YN2015MS21
• Status: Recruiting
• Phase: N/A
• First received: June 7, 2017
• Last updated: December 5, 2017
• Start date: December 5, 2017
• Est. completion date: August 31, 2018

Study information

• Verified date: December 2017
• Source: Guangdong Provincial Hospital of Traditional Chinese Medicine
• Contact: Lei Wang, Ph.D & M.D
• Phone: 86-20-81887233-32801
• Email: Dr.wanglei[@]139.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: August 31, 2018
• Est. primary completion date: May 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Syndrome

Intervention

Drug:
• Compound Panax Notoginseng Granule
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
Placebo granule has the same as Compound Panax Notoginseng Granule in the appearance, shape,colour,taste,frequency and duration.

Locations

Country	Name	City	State
China	Guangdong Provincial Hospital of Chinese Medicine	Guangzhou	Guangdong

Sponsors (2)

Lead Sponsor	Collaborator
Guangdong Provincial Hospital of Traditional Chinese Medicine	Beijing Genomics Institute

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the plasma level of TMAO	Trimethylamine-N-Oxide(µM) is relative to the prognostic of ACS.	baseline
Primary	the plasma level of TMAO	Trimethylamine-N-Oxide(µM) is relative to the prognostic of ACS.	90-days post-procedure
Secondary	metagenomic DNA sequencing analysis of faecal microbiome	high-throughput sequencing and big data analytics	baseline
Secondary	metagenomic DNA sequencing analysis of faecal microbiome	high-throughput sequencing and big data analytics	90-days post-procedure
Secondary	major adverse cardiac event	frequency of the reported cardiovascular events (defined as death, non fatal myocardial infarction,target vessel revascularization and stent thrombosis )	90-days post-procedure
Secondary	cardiac function	left ventricular ejection fraction(LVEF) evaluated by echo	baseline
Secondary	cardiac function	left ventricular ejection fraction(LVEF) evaluated by echo	90-day at follow-up
Secondary	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).	90-days
Secondary	The traditional Chinese medicine syndrome scale	The score of phlegm and of blood stasis syndromes is evaluated by Phlegm and blood stasis syndrome questionnaire.	change from baseline at 90-days
Secondary	lipid metabolism	low-density lipoprote in cholesterol in mmol/L	change from baseline at 90-days
Secondary	lipid metabolism	total cholesterol in cholesterol in mmol/L	change from baseline at 90-days
Secondary	inflammatory factors	C-reactive protein in mg/L	change from baseline at 90-days
Secondary	platelet function	maximal aggregation rate of platelet in percent	change from Baseline at 90-days
Secondary	cardiac biomarkers of necrosis	cardiac troponin T (cTnT) in ug/L	Change from Baseline at 5 days