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

NCT03186625 | Unknown

• 1 other identifier: YN2015MS21
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Coronary Syndrome

Keywords

acute coronary syndrome; gut microbiota; Trimethylamine N-oxide; percutaneous coronary intervention

Outcome Measures

Primary Outcomes (2)

• the plasma level of TMAO

  Trimethylamine-N-Oxide(μM) is relative to the prognostic of ACS.

  baseline

• the plasma level of TMAO

  Trimethylamine-N-Oxide(μM) is relative to the prognostic of ACS.

  90-days post-procedure

Secondary Outcomes (12)

• metagenomic DNA sequencing analysis of faecal microbiome

  baseline

• metagenomic DNA sequencing analysis of faecal microbiome

  90-days post-procedure

• major adverse cardiac event

  90-days post-procedure

• cardiac function

  baseline

• cardiac function

  90-day at follow-up

Study Arms (2)

Compound Panax Notoginseng Granule

EXPERIMENTAL

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

Drug: Compound Panax Notoginseng Granule

Placebo Granule

PLACEBO COMPARATOR

On the basis of the standard treatment for ACS,eligible participants are randomized to receive Placebo Granule when they enroll.

Drug: Placebo Granule

Interventions

Compound Panax Notoginseng Granule DRUG

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.

Compound Panax Notoginseng Granule

Placebo Granule DRUG

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

Placebo Granule

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Guangdong Provincial Hospital of Traditional Chinese Medicine: lead
• Beijing Genomics Institute: collaborator

Study Sites (1)

Guangdong Provincial Hospital of Chinese Medicine

Guangzhou, Guangdong, 510120, China

RECRUITING

MeSH Terms

Conditions

Acute Coronary Syndrome

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Study Officials

• Xiaoyan Li, Master

  Guangdong Provincial Hospital of Traditional Chinese Medicine

  STUDY DIRECTOR

Central Study Contacts

Lei Wang, Ph.D & M.D

CONTACT

86-20-81887233-32801; Dr.wanglei@139.com

Shuai Mao, M.D

CONTACT

+8613724078381; maoshuaitcm@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Chief Physician

Study Record Dates

• First Submitted: June 7, 2017
• First Posted: June 14, 2017
• Study Start: December 5, 2017
• Primary Completion: May 31, 2018
• Study Completion: August 31, 2018
• Last Updated: December 7, 2017

Record last verified: 2017-12

Locations

CN (1)