Prospective Evaluation of a Screening Methodology for Chronic Obstructive Pulmonary Disease in Patients Admitted to Hospital for Acute Coronary Syndromes.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 137
- 试验地点
- 2
- 主要终点
- COPD Diagnosis
研究概览
简要总结
Several studies and registries suggested that the concomitant presence of acute coronary syndromes (ACS) and chronic obstructive pulmonary disease (COPD) is significantly associated with poor prognosis. It has been suggested that diagnosis of COPD is frequently missing. Thus, it is plausible that a significant percentage of patients with ACS may have unrecognized COPD. This missing diagnosis may contribute significantly to poor prognosis. The investigators suppose that the concomitant use of peak expiratory flow (PEF) measurement and of Respiratory Health Screening Questionnaire (RHSQ, adapted version) could be useful as screening test for COPD in patient smokers or former smokers admitted to hospital with a diagnosis of ACS. In all screened patients COPD diagnosis will be confirmed (or not) two months after hospital discharge with spirometry. In the same setting of patients, the investigators will characterize the underlying pathological mechanisms, evaluating several inflammation, platelet and endothelial markers.
详细描述
BACKGROUND:
Acute coronary syndromes (ACS) and chronic obstructive pulmonary disease (COPD) are respectively the first and the fourth leading cause of death in Western countries. ACS and COPD shared several risk factor, in particular smoking habitus. Available data may be summarized as follows: i) ACS, and generally ischemic heart disease (IHD), are the most frequent comorbidity in COPD patients; ii) cardiac adverse events are the most frequent cause of hospitalization and/or death in COPD patients; iii) patients with ACS and concomitant COPD are at higher risk of mortality, re-infarction and heart failure (HF); iv) COPD is frequently undiagnosed in patients with IHD. At the best of our knowledge, no studies investigated the effectiveness and feasibility of screening procedures to early detect COPD in ACS patients. The identification of unrecognized COPD in ACS patients may permit an optimization of the treatment with an significant improvement in the outcome. Finally, it is well known that several biological processes are involved in the development and worsening of IHD-COPD comorbidity (e.g. inflammation, hypoxia, heightened platelet reactivity, endothelial dysfunction). Nevertheless, a complete evaluation of these processes is currently missing. A better characterization of these biological processes underlying the ACS-COPD comorbidity may significantly improve its management.
HYPOTHESIS and SIGNIFICANCE:
Based on previous studies in patients with stable IHD, we suppose that at least 30% of patients admitted to hospital for ACS have undiagnosed COPD. They represent a subgroup of patients at very high risk of death, reinfarction and heart failure. We hypothesize that the combined use of PEF and RHSQ (adapted version) in ACS patients (smokers or former smokers) before hospital discharge may discriminate those with undiagnosed COPD. The early diagnosis of COPD comorbidity may have important clinical implications. We speculate that early identification of undiagnosed COPD in ACS patients may permit a promptly treatment and improve outcomes. Finally, we suppose that the worst outcome observed in ACS patients with undiagnosed COPD as well as in patients with prior ACS and acute exacerbation of COPD is due to a specific pattern of alterations in platelet reactivity (PR), endothelial function (EF) and inflammation. Therefore, their characterization may lead to an improvement in the clinical management of these patients.
METHODS:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 90 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age >40 years
- •typical chest pain during at least 20 minutes
- •ST-segment changes on electrocardiography, indicating ischemia and/or positive test of a biomarker (troponin and/or CK-MB), indicating myocardial necrosis
- •current or former history of smoking
排除标准
- •previous diagnosis of COPD and/or asthma
- •known pulmonary disease
- •ongoing pneumonia
- •ongoing heart failure
- •documented or suspicion of malignant disease
- •life expectancy <1 year
- •recent thoracic trauma
研究组 & 干预措施
screening test
all consecutive patients admitted to our hospital for ACS and current/former smokers will be screened according our protocol with PEF and RHSQ. Patients will be blinded to result of both tests. Indipendently to results, all included patients will receive spirometry (50-70 days after inclusion) to assess the presence or not of COPD (primary outcome).
干预措施: screening test (Other)
结局指标
主要结局
COPD Diagnosis
时间窗: 2 months after inclusion
COPD diagnosis confirmed by spirometry
次要结局
- Cardiac Adverse Events(1 year after inclusion)
- Undiagnosed COPD(2 months)
研究者
Gianluca Campo
MD
University Hospital of Ferrara
