Acute Coronary Syndrome
Conditions
Keywords
acute coronary syndrome, gut microbiota, Trimethylamine N-oxide, percutaneous coronary intervention
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.
Interventions
DRUGCompound 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.
DRUGPlacebo Granule
Placebo granule has the same as Compound Panax Notoginseng Granule in the appearance, shape,colour,taste,frequency and duration.
Sponsors
Beijing Genomics Institute
Guangdong Provincial Hospital of Traditional Chinese Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| the plasma level of TMAO | baseline | Trimethylamine-N-Oxide(μM) is relative to the prognostic of ACS. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| metagenomic DNA sequencing analysis of faecal microbiome | baseline | high-throughput sequencing and big data analytics |
| 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 ) |
| cardiac function | baseline | 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). |
| 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 | low-density lipoprote in cholesterol in mmol/L |
| inflammatory factors | change from baseline at 90-days | C-reactive protein in mg/L |
| platelet function | change from Baseline at 90-days | maximal aggregation rate of platelet in percent |
| 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. |
Countries
China
Contacts
Primary ContactLei Wang, Ph.D & M.D
Backup ContactShuai Mao, M.D
Outcome results
None listed