Early Cardiovascular Risk Assessment of Patients With COPD During Respiratory Exacerbation for the Identification and Treatment of Cardiovascular Comorbidity
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Cardiovascular-related treatment change in 6 months
研究概览
简要总结
This is a research study involving patients hospitalized for COPD flare-ups. Patients will be assigned using a non-randomized, sequential allocation strategy (a control cohort followed by an intervention cohort) to two groups: one group will only see a pulmonologist (lung doctor), and the other group will also be seen by a cardiologist (heart doctor) during their hospital stay. Both groups will fill out a questionnaire, and the pulmonologist will review their lung disease, adjust their treatment, and recommend follow-up care. The cardiologist will also assess the second group for heart diseases (like high cholesterol, diabetes, heart disease, high blood pressure, or heart failure) and start or adjust heart treatment if needed. Both groups will be followed up by phone 1, 3, 6 and 12 months later to check for changes in treatment, new heart problems, COPD flare-ups, or death.
详细描述
This is a single-center, prospective study involving patients hospitalized for COPD exacerbation. Eligible patients will be identified either by the internal medicine department doctors or by reviewing the admission diagnoses of hospitalized patients in the hospital's database. After obtaining informed consent, the patients will be assigned into one of two sequential cohorts (a control cohort followed by an intervention cohort).
Both groups will complete a background questionnaire and will be assessed by a pulmonologist during the hospitalization, who will focus on their lung disease, optimize basic treatment, and recommend follow-up as needed. The intervention group will undergo an additional evaluation by a cardiologist during the hospitalization, who will check for cardiovascular diseases (such as hyperlipidemia, diabetes, ischemic heart disease, hypertension, or heart failure) and adjust or start treatment according to new or existing diagnoses.
Both groups will receive follow-up phone calls about 1, 3, 6, and 12 months later to evaluate any changes in treatment following the intervention, new diagnoses or events of cardiovascular diseases, COPD exacerbations, and mortality.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Screening
- 盲法
- Single (Outcomes Assessor)
盲法说明
The interviewer in the 1, 3, 6 and 12 months phone call follow-up will be blinded to group allocation.
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
- 否
入选标准
- •Documented COPD (based on lung function tests, symptoms and relevant treatment).
- •Aged 18-75 years.
- •Mentally competent to understand and follow medical recommendations.
排除标准
- •Under 18 years of age.
- •Unable to provide consent.
- •Unstable concurrent disease.
研究组 & 干预措施
Intervention
Patients will be evaluated by a pulmonologist during their admission, in addition to a cardiologist, aiming to identify cardiovascular comorbidities including dyslipidemia, diabetes, hypertension, ischemic heart disease, heart failure, valvular disease, personal or family history of ischemic heart disease, and smoking. Part of the evaluation will include assessing the management of diagnosed cardiovascular conditions. Finally, recommendations for further investigation or initiation of drug treatment will be made.
干预措施: Cardiologist evaluation (Other)
Intervention
Patients will be evaluated by a pulmonologist during their admission, in addition to a cardiologist, aiming to identify cardiovascular comorbidities including dyslipidemia, diabetes, hypertension, ischemic heart disease, heart failure, valvular disease, personal or family history of ischemic heart disease, and smoking. Part of the evaluation will include assessing the management of diagnosed cardiovascular conditions. Finally, recommendations for further investigation or initiation of drug treatment will be made.
干预措施: Pulmonologist evaluation (Other)
Control
Patients will be evaluated by a pulmonologist during their hospitalization, who will focus on their pulmonary condition, optimize basic treatment, and recommend continued follow-up as needed.
干预措施: Pulmonologist evaluation (Other)
结局指标
主要结局
Cardiovascular-related treatment change in 6 months
时间窗: From enrollment to 6 months follow-up call
New pharmacological treatment or intervention (e.g., angiography, surgery) for cardiovascular disease, including diabetes, hypertension, dyslipidemia, ischemic heart disease, stroke, valvular disease, or heart failure compared to at inclusion.
次要结局
- COPD severe exacerbations(6 months from study recruitment)
- Diagnosis of new cardiovascular comorbidity(From inclusion to hospital discharge)
- Extended diagnosis of new cardiovascular comorbidity(At 6 months after enrollment.)
- Adverse outcomes(At 3 and 6 months from study enrollment)
- MACE(At 3 and 6 months from enrollment)
- Time to MACE(6 months from enrollment)
- COPD exacerbations(3 and 6 months from enrollment)