The HELlenic Thoracic Society Initiative for CΟPD and CVD
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 900
- 试验地点
- 2
- 主要终点
- Number of moderate or severe COPD exacerbations
研究概览
简要总结
COPD is one of the most common respiratory diseases in Greece, and maybe more than half a million Greek citizens suffer both from COPD and CVD, however their characteristics and management remain unknown. HELICOPD is a national, multicenter, prospective, non-interventional study designed to contribute to better understanding and depicting the demographic and clinical characteristics of this population, the COPD- and CVD-related adverse events in a two-years period, their quality of life and the healthcare resources use. The study is initiated and coordinated by the Hellenic Thoracic Society.
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
- 35 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients should cumulatively meet the following three (3) criteria to be enrolled in the study:
- •To have been diagnosed with chronic obstructive pulmonary disease and at least one cardiovascular comorbidity (heart failure, atherosclerotic cardiovascular disease, atrial Fibrillation, severe valvular disease)
- •Adults aged >35 years at the time of inclusion in the study,
- •With signed informed consent for their participation in the study.
排除标准
- •Patients with the below limitations are not eligible to participate in the study
- •Without at least one cardiovascular comorbidity,
- •With history of lung cancer
- •With any other active malignancy and undergoing treatment (chemotherapy/radiotherapy/immunotherapy)
- •With any thoracic or abdominal surgery planned during study follow-up period
- •With participation in any COPD-related interventional study at study entry or during study duration.
- •Without signed informed consent for their participation in the study.
研究组 & 干预措施
COPD patients with cardiovascular comorbidities
结局指标
主要结局
Number of moderate or severe COPD exacerbations
时间窗: Up to 24 months
Moderate COPD exacerbation: typically requires outpatient management, it is characterized by an increased need for medication, specifically the use of systemic corticosteroids and/or antibiotics. Severe COPD exacerbation: indicated by an acute worsening of symptoms that requires hospitalization.
Number of cardiovascular complications/outcomes
时间窗: Up to 24 months
Cardiovascular complications/outcomes, including a) acute coronary syndrome, b) ischemic stroke, c) pulmonary embolism, d) reperfusion, e) worsening of heart failure that required a visit to the Emergency Department (ED) or hospitalization (short or longer), f) other hospitalization in a cardiology clinic (causes other than acute coronary syndrome, reperfusion, and heart failure), g) death related to cardiovascular disease.
次要结局
- Unscheduled hospital admission due to COPD(Up to 24 months)
- Unscheduled hospital admission due to any other reason(Up to 24 months)