Association Analysis of Cardiovascular and Nervous System Diseases and Intestinal Microbiome Based on Multi-omics Big Data and Related Applications
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 490
- 试验地点
- 1
- 主要终点
- Stool sampling
研究概览
简要总结
Research purpose
- Combined with multi-omics data and advanced data mining methods, we explored the pathogenesis and potential application pathway of intestinal microbiome mediated by specific cardiovascular diseases (such as idiopathic ventricular tachycardia, stenosis after coronary artery stenting injury, etc.) and nervous system diseases (such as carotid atherosclerosis, moyamoya disease, etc.).
- The secondary goal of this study is the construction of risk prediction model. Based on the pathogenesis identified by multi-omics association analysis, detailed dietary information and clinical information related to cardiovascular and nervous system diseases, the risk of cardiovascular and nervous system diseases was assessed and the disease risk model was constructed.
- Based on the key genes and microorganisms excavated, disease-related machine learning models can be built, and models can be built to prevent and treat diseases.
Research background Cardiovascular and nervous system diseases such as arrhythmias (atrial fibrillation, ventricular tachycardia, ventricular fibrillation, postoperative vascular stenosis injury, etc.), heart failure, atherosclerosis (coronary heart disease, stroke, peripheral vascular disease, carotid atherosclerosis, etc.), epilepsy, moyamoya disease, etc., are currently leading to the main diseases affecting the health and death of residents in China.
Through the unremitting efforts of many scientists, the research on the association between intestinal flora and cardiovascular diseases (ventricular tachycardia/atrial fibrillation, carotid atherosclerosis, etc.) and nervous system diseases (Parkinson's disease, epilepsy, carotid atherosclerosis, etc.) has made breakthrough progress. However, the study of gut microbiota is still in its infancy, and it is not possible to deeply understand the complex regulatory processes between heart disease and nervous system diseases and gut microbiota, involving a large number of host genes, host metabolites, and associated bacteria and bacteria-related metabolites. Based on multi-omics data, the data integration method combined with machine learning analyzes the connection between cardiovascular and nervous system and gut microbes, helping to deepen the research on the mechanism related to heart disease and nervous system under the regulation of gut microbes and providing new ideas for the prevention and treatment of related diseases. This study will also promote the implementation of clinical interventions with precise flora and provide new ideas for the treatment of cardiovascular diseases and neurological diseases.
详细描述
A microbial ecosystem is a complex community of interacting bacteria. The potential role of intestinal flora in human health has attracted extensive attention. Imbalances in the gut microbiome have been implicated in a variety of chronic diseases. Cardiovascular diseases (CVDs) are the leading cause of morbidity worldwide and are influenced by both genetic and environmental factors. Recent advances have provided scientific evidence that cardiovascular disease may also be attributable to gut microbiota. In many literatures, we have found complex interactions between microorganisms, their metabolites, and potential impacts on the development and progression of cardiovascular disease. The use of intestinal flora in the treatment of cardiovascular diseases is the latest research direction. Gut microbes are likely to be used in the clinical treatment of cardiovascular diseases in the near future.
Gut flora plays an important role in human health and disease transformation. It not only participates in many physiological processes of the host, but also affects the function of the central nervous system (CNS) through the activity of the microbiota - gut - brain axis, which may be closely related to neurotransmitter, immune, endocrine and metabolite pathways. When the intestinal flora is dysfunctional, it can affect the occurrence and development of CNS diseases such as cerebral ischemia, Parkinson's disease, Alzheimer's disease, multiple sclerosis, hepatic encephalopathy and mental disorders. Fecal microbial transplantation, exercise training, acupuncture and massage and other therapies can improve intestinal flora disorders, and are expected to become effective measures to treat and prevent some nervous system diseases.
- Subject selection basis Based on electrocardiogram, blood test or B-ultrasonography and other examination methods, combined with clinical manifestations, patients judged by professional physicians as meeting the inclusion criteria of this experimental protocol will be included in the study cohort for study.
- Dosage selection/administration plan/dosage adjustment basis This study did not involve intervention experiments, and there was no dose selection/dosing regimen/dose adjustment.
- Basis for destination selection This experiment is not an intervention experiment, so the end point of this experiment is chosen after the subjects are diagnosed with related diseases or the control group, and the end point is taken after the completion of sampling.
- Risk and benefit basis For patients with specific cardiovascular and cerebrovascular diseases, the benefits of this trial far outweigh the risks. This experiment will collect fecal samples in vitro, which is a non-invasive sample collection, which will not cause trauma to patients and has high safety. This project will also collect peripheral blood samples from patients for study. The process of collecting blood samples may involve pain and other reactions, but the operations involved in this study are all carried out by experienced nurses and nurses to minimize such risks.
This experiment will contribute to the research of cardiovascular and nervous system-related diseases. By elucidating the molecular mechanism of intestinal microorganisms regulating cardiovascular and nervous system diseases, disease-related genes and biomarkers can be found, promoting the accurate diagnosis of diseases, providing targets for the precise treatment and prevention of diseases, and providing targeted regulation of the structure and metabolite composition of microorganisms. Prevention and treatment of related diseases.
Research content
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Stool sampling
时间窗: One month after the patient is clinically diagnosed with the above disease
① Sampling should be taken at the non-eating stage between 6am and 9am Before sampling, stool must be emptied into a clean and dry urinal or container containing filter paper. Note: Urine should not be mixed into the container. ② Use a small spoon in the sampler to collect feces. Note: In order to prevent contamination of the stool surface, gently peel the surface with a sampling spoon, and sample the inside of the stool, placing it in an average of three feces tubes. ③ After sampling, close the cover of the collector and mark the name and sampling time on the collector with a pen. Store at room temperature for 1 day, long-term storage at -80℃. Note: The sampler should not take antibiotics or other drugs for 45 days.
Blood collection
时间窗: One month after the patient is clinically diagnosed with the above disease
① Collect 5-10ml blood of the subject, centrifuge, collect serum and plasma, temporarily do not test, can be immediately frozen at low temperature, the lower the temperature is better, if not repeated freezing and thawing in the middle, can be stored for one month below -20℃, can be stored for three months below -80℃. ② Citrate anticoagulant and plasma collection: Sodium citrate acts as an anticoagulant by acting on calcium ion chelation in blood samples, recommended by the National Committee for Standardization of Clinical Laboratories (NCCLS) is 3.2% or 3.8%, and the anticoagulant to blood ratio is 1: 9, mainly used in the fibrinolytic system (prothrombin time, thrombin time, activated partial thrombin time, fibrinogen). When taking blood, attention should be paid to taking enough blood to ensure the accuracy of the test results, and the blood should be gently reversed and mixed 5-8 times immediately after taking blood.
次要结局
未报告次要终点
研究者
Tao Xin
Director of Neurosurgery
Qianfoshan Hospital