Clinical trial NCT03186625: Impact of Traditional Chinese Medicine on the Gut Microbiota-dependent Trimethylamine N-oxide
Official title: Impact of Traditional Chinese Medicine on the Gut Microbiota-dependent Trimethylamine N-oxide in Acute Coronary Syndromes : A Randomized Placebo Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Acute Coronary Syndrome
Keywords: acute coronary syndrome
gut microbiota
Trimethylamine N-oxide
percutaneous coronary intervention
Lead sponsor: Guangdong Provincial Hospital of Traditional Chinese Medicine
Sponsor class: OTHER
Collaborators: name: Beijing Genomics Institute
First posted: 2017-06-14
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: the plasma level of TMAO
timeFrame: baseline
measure: the plasma level of TMAO
timeFrame: 90-days post-procedure
Secondary outcomes:
measure: metagenomic DNA sequencing analysis of faecal microbiome
timeFrame: baseline
measure: metagenomic DNA sequencing analysis of faecal microbiome
timeFrame: 90-days post-procedure
measure: major adverse cardiac event
timeFrame: 90-days post-procedure
measure: cardiac function
timeFrame: baseline
measure: cardiac function
timeFrame: 90-day at follow-up
measure: Seattle Angina Questionnaire score
timeFrame: 90-days
measure: The traditional Chinese medicine syndrome scale
timeFrame: change from baseline at 90-days
measure: lipid metabolism
timeFrame: change from baseline at 90-days
measure: lipid metabolism
timeFrame: change from baseline at 90-days
measure: inflammatory factors
timeFrame: change from baseline at 90-days
measure: platelet function
timeFrame: change from Baseline at 90-days
measure: cardiac biomarkers of necrosis
timeFrame: Change from Baseline at 5 days
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Guangdong Provincial Hospital of Chinese Medicine
state: Guangdong
Study officials:
affiliation: Guangdong Provincial Hospital of Traditional Chinese Medicine
name: Xiaoyan Li, Master
role: STUDY_DIRECTOR
References: