Airflow Limitation in Cardiac Diseases in Europe
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 3,000
- 试验地点
- 1
- 主要终点
- Prevalence of Airflow Limitation
研究概览
简要总结
This is a cross-sectional, observational study, investigating the point prevalence of Airflow Limitation in current or former smokers with established ischemic heart disease. The study will recruit up to 3000 patients from cardiology clinics at hospitals across Europe.
详细描述
Airflow limitation (AL) occurs in a number of respiratory diseases including asthma and COPD; in middle-aged and older patients it typically represents Chronic Obstructive Pulmonary Disease (COPD), and is associated with a high degree of co-morbidity which includes cardiovascular diseases (CVD) and risk factors such as hypertension and diabetes.
COPD often goes undiagnosed, especially in patients with established coronary disease because COPD and cardiovascular diseases share a major etiological factor: smoking.
This cross-sectional, observational study, investigating the prevalence of AL in current or former smokers with established ischemic heart disease, aims increase the knowledge and understanding of COPD in this patient population, and to highlight the burden of comorbid disease in these patient
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
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects aged ≥40 years;
- •Current or former smokers with ≥10 pack years;
- •Subjects attending outpatient cardiac clinic (or equivalent) fulfilling any of the following criteria:
- •Documented history of an Ischemic event,
- •Current diagnosis of stable IHD (including history of acute Myocardial Infarction (MI) and angina pectoris) as diagnosed in accordance with ESC guidelines
- •Receiving regular therapy for IHD for >1yr, Subjects meeting these criteria will be eligible for the study, even if they have other cardiac diseases or other co-morbidities;
- •Subjects willing and able to sign study consent form.
排除标准
- •Subjects for whom spirometry is contraindicated;
- •Subjects with recent surgery or MI (within 1 month); lower respiratory tract infection or pneumothorax (within 2 months); or stroke (within 12 months);
- •Subjects with a pre-existing condition which, in the opinion of the investigator, would compromise the safety of the subject in this study
结局指标
主要结局
Prevalence of Airflow Limitation
时间窗: 1 day
Prevalence of AL as defined by Forced Expired Volume in 1 second (FEV1)/Forced Volume Capacity (FVC) \< 0.70 (post bronchodilator)
次要结局
- Severity of AL(1 day)
- Presence of past history of AL/COPD(1 day)
- Healthcare resource utilisation(within previous 12 months)
- prevalence of restrictive AL(1 day)
- Prevalence of AL(1 day)
- COPD Assessment test™ (CAT)(1 day)
- Short Form 12 (SF12)(1 day)
- Cardiac Health Profile (CHP)(1 day)