Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Beijing Genomics Institute | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Placebo Granule | Placebo Comparator | On the basis of the standard treatment for ACS,eligible participants are randomized to receive Placebo Granule when they enroll. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| metagenomic DNA sequencing analysis of faecal microbiome | high-throughput sequencing and big data analytics | baseline |
| metagenomic DNA sequencing analysis of faecal microbiome | high-throughput sequencing and big data analytics |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lei Wang, Ph.D & M.D | Contact | 86-20-81887233-32801 | Dr.wanglei@139.com | |
| Shuai Mao, M.D | Contact | +8613724078381 | maoshuaitcm@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Xiaoyan Li, Master | Guangdong Provincial Hospital of Traditional Chinese Medicine | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Guangdong Provincial Hospital of Chinese Medicine | Recruiting | Guangzhou | Guangdong | 510120 | China |
Not provided
| ID | Term |
|---|---|
| D054058 | Acute Coronary Syndrome |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Placebo Granule | Drug | Placebo granule has the same as Compound Panax Notoginseng Granule in the appearance, shape,colour,taste,frequency and duration. |
|
| 90-days post-procedure |
| 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 |
| cardiac function | left ventricular ejection fraction(LVEF) evaluated by echo | baseline |
| cardiac function | left ventricular ejection fraction(LVEF) evaluated by echo | 90-day at follow-up |
| 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 |
| 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 |
| lipid metabolism | low-density lipoprote in cholesterol in mmol/L | change from baseline at 90-days |
| lipid metabolism | total cholesterol in cholesterol in mmol/L | change from baseline at 90-days |
| inflammatory factors | C-reactive protein in mg/L | change from baseline at 90-days |
| platelet function | maximal aggregation rate of platelet in percent | change from Baseline at 90-days |
| cardiac biomarkers of necrosis | cardiac troponin T (cTnT) in ug/L | Change from Baseline at 5 days |