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临床试验/NCT06562309
NCT06562309已完成不适用

Fecal Microbiota and Monocyte Trained Immunity in Patients With Coronary Heart Disease and Different Level of High-sensitivity C-reactive Protein (hsCRP)

Wuhan Union Hospital, China1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2021年5月11日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
100
试验地点
1
主要终点
blood monocytes trained immunity

研究概览

简要总结

This single-center study enrolled patients aged 35-75 years who were diagnosed with unstable angina (UA), and had at least one of the three major coronary arteries with a ≥ 50% reduction in lumen diameter by angiographic visual estimation. Patients were all recruited at the Department of Cardiology, Union Hospital, Wuhan, Hubei Province, China. Feces and blood samples were collected on admission were used promptly for ex vivo studies.

详细描述

This single-center study enrolled patients aged 35-75 years who were diagnosed with unstable angina (UA), and had at least one of the three major coronary arteries with a ≥ 50% reduction in lumen diameter by angiographic visual estimation. Patients were all recruited at the Department of Cardiology, Union Hospital, Wuhan, Hubei Province, China. Exclusion criteria included acute myocardial infarction, prior myocardial infarction, malignancies, auto-immune or auto-inflammatory diseases, or ongoing infection. Feces and blood samples were collected on admission were used promptly for ex vivo studies.

the aim of the study is to investigate whether the fecal microbiota and peripheral blood monocytes in patients with coronary heart disease at different levels of inflammation are associated with the level of inflammation.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Cross Sectional

入排标准

年龄范围
35 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age >35 and <75 years
  • Admitted for UA and had at least one of the three major coronary arteries with ≥50% reduction in lumen diameter by angiographic visual estimation
  • Informed consent obtained

排除标准

  • Prior myocardial infarction
  • Left ventricular ejection fraction ≤ 40% on echocardiography
  • Have a history of malignancies, auto-immune, auto-inflammatory disease or on immunomodulatory medication
  • Ongoing acute, chronic, or concurrent infectious disease
  • Surgery 3 months before sample collection
  • Immunization with a vaccine within 4 weeks before sample collection
  • Pregnancy, or breast feeding
  • History of primary or secondary immunodeficiency
  • Renal failure with estimated glomerular filtration rate (eGFR) < 60 mL/min/1.73m2
  • Active liver disease with alanine aminotransferase (ALT >80 U/L) or aspartate aminotransferase (AST > 80 U/L)
  • History of chronic obstructive pulmonary disease (COPD)
  • Refuse to provide written consent
  • Any other circumstances in which the investigator judges that the patient is not suitable

结局指标

主要结局

blood monocytes trained immunity

时间窗: within 3 days

1.Blood monocytes were detected by flowcytometry to evaluate the monocyte subsets and CCR2 expression; 2. monocytes were enriched from blood cells and used for ex vivo lipopolysaccharide stimulation, mRNA sequencing and ATAC sequencing; 3.The metabolic bias of monocytes was detected by Seahorse technology and metabolics.

次要结局

  • fecal microbiome profile(within 3 days)

研究者

发起方
Wuhan Union Hospital, China
申办方类型
Other
责任方
Principal Investigator
主要研究者

Xiang Cheng

Professor

Wuhan Union Hospital, China

研究点 (1)

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