Risk Prediction Model for Exacerbating Phenotype in Patients With Chronic Obstructive Pulmonary Disease
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Chronic Obstructive Pulmonary Disease Severe. Basic parameters: 40 years — 85 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Risk-predictive Model for Frequent Acute Exacerbation Phenotype in Patients With Severe Chronic Obstructive Pulmonary Disease
Overview
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.
Primary outcome measures
- Evaluate the predictive performance of the COPD frequent seizure risk prediction model based on the area under the ROC curve. [Time frame: A year]
Eligibility criteria
Inclusion criteria
- 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
Exclusion criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Study design
- Observational model
- Case-control
Study locations
China · 1 center
- Beijing Chaoyang Hospital Affiliated to Capital Medical University — Beijing
Identifiers
NCT: NCT06198309 · al123456