Influence of Frailty on Cardiovascular Events and Mortality in Patients With Chronic Obstructive Pulmonary Disease (COPD): A Multicentre Observational Study.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Number of cardiovascular events in COPD patients living with frailty vs non-frail COPD. patients.
研究概览
简要总结
Observational study on the influence of frailty on cardiovascular risk in COPD.
详细描述
The study will investigate the influence that frailty can have on cardiovascular risk in patients with COPD. The project will assess the association between frailty and all-cause mortality, and the relationship between frailty and cardiovascular mortality, by comparing COPD patients living with frailty vs non-frail COPD patients.
The study participants will be outpatients with diagnosis of COPD according to the Global Initiative for Chronic Obstructive Pulmonary Disease (GOLD) guidelines (www.goldcopd.org).
Frailty will be measured using the Clinical Frailty Scale (grades 1-9). Patients who are terminally ill (CFS = 9) will be excluded. Cognitive function will be explored using the Montreal Cognitive Assessment (MoCA) test.
The follow up will be at 12 and 24 months.
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
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with age ≥18 years, with diagnosis of COPD of at least 1 year, in stable condition, without acute exacerbation in the last 30 days and/or all-cause hospitalisation in the last 3 months
- •Smoking history of ≥ 10 pack/years
- •Diagnosis of COPD according to GOLD guidelines (www.goldcopd.org)
- •Individuals able to provide their written informed consent.
排除标准
- •Concurrent diagnosis of interstitial lung disease
- •Presence of restrictive pattern on spirometry
- •No history of smoking habit
- •Individuals not able to provide their written informed consent.
结局指标
主要结局
Number of cardiovascular events in COPD patients living with frailty vs non-frail COPD. patients.
时间窗: 12 and 24 months
Number of cardiovascular events (including hospital admissions for cardiovascular events) at 12 and 24 months in COPD patients living with frailty vs non-frail COPD patients.
次要结局
- Prevalence of frailty in COPD.(Baseline, at 12 and 24 months)
- All-cause long-term mortality in COPD patients living with frailty vs non-frail COPD patients.(12 and 24 months)
- Cardiovascular mortality in COPD patients living with frailty vs non-frail COPD patients.(12 and 24 months)
- Deaths due to COPD in COPD patients living with frailty vs non-frail COPD patients.(12 and 24 months)
研究者
Alessia Verduri
Dr Alessia Verduri
Azienda Ospedaliero-Universitaria di Modena