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临床试验/NCT06198309
NCT06198309招募中不适用

A Risk-predictive Model for Frequent Acute Exacerbation Phenotype in Patients With Severe Chronic Obstructive Pulmonary Disease

Li An1 个研究点 分布在 1 个国家目标入组 365 人开始时间: 2023年5月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
365
试验地点
1
主要终点
Evaluate the predictive performance of the COPD frequent seizure risk prediction model based on the area under the ROC curve.

研究概览

简要总结

This study is planned to be conducted based on the cohort of patients with severe chronic obstructive pulmonary disease in our hospital. Based on gut microbiota, random forest was used to search for potential diagnostic biomarkers in patients with frequent acute exacerbation and controls with non frequent acute exacerbation; Construct a frequent acute exacerbation risk prediction model using random forest, support vector machine, and BP neural network models. The development of this study will provide valuable references for the clinical classification and prognosis evaluation of chronic obstructive pulmonary disease (COPD), and improve the health level of COPD patients by further searching for treatable targets.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
40 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients who meet the diagnostic criteria for COPD of the global initiative for chronic obstructive lung diseases (GOLD 2022) and GOLD grading Ⅲ - Ⅳ (FEV1/FVC<70%, FEV1% predicted value ≤ 50% after Bronchiectasis)
  • Age>40 years old
  • COPD stable for more than 4 weeks
  • Short acting Bronchiectasis was not used within 24 hours before this experiment, long acting Bronchiectasis was not used within 48 hours, and glucocorticoids were not used throughout the body in the past month
  • Patient informed and signed consent form

排除标准

  • Asthma, active pulmonary tuberculosis, interstitial pneumonia and severe Bronchiectasis
  • Complicated with serious diseases (acute infection, diabetes, stroke, heart disease, liver and kidney dysfunction, cancer or autoimmune disease)
  • History of chronic diarrhea or constipation
  • History of Gastrointestinal Surgery
  • Using probiotics or antibiotics within the past 4 weeks
  • No history of using oral hormones or traditional Chinese medicine in the past three months
  • Pregnancy or lactation

结局指标

主要结局

Evaluate the predictive performance of the COPD frequent seizure risk prediction model based on the area under the ROC curve.

时间窗: A year

According to the Area Under Curve (AUC) of ROC, the largest one has the best predictive performance. When AUC\>0.5, the closer it is to 1, the better the predictive performance of the model. When AUC=0.5, it indicates poor model fitting and no potential predictive value.

次要结局

未报告次要终点

研究者

发起方
Li An
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Li An

chief physician

Beijing Chao Yang Hospital

研究点 (1)

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