Airflow Limitation in Cardiac Diseases in Europe

Study Overview
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Brief Summary
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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.

Detailed Description
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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

Official Title
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Airflow Limitation in Cardiac Diseases in Europe

Conditions
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Pulmonary Disease, Chronic Obstructive

Intervention / Treatment
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* Procedure: Spirometry


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| All<br>All subjects enrolled in the study | Procedure: Spirometry<br>* assessment of lung function by spirometry<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevalence of Airflow Limitation | Prevalence of AL as defined by Forced Expired Volume in 1 second (FEV1)/Forced Volume Capacity (FVC) < 0.70 (post bronchodilator) | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Severity of AL | Severity of AL as determined by predicted FEV1 (post-bronchodilator) - mild: ≥80%, moderate: 50-80%, severe: 30-50%, very severe: <30%, or <50% plus chronic respiratory failure | 1 day | 
| prevalence of restrictive AL | Prevlence of restrictive AL FEV1/FVC ≥0.70 and a predicted FVC <80% (pre bronchodilator) | 1 day | 
| Prevalence of AL | Prevalence of AL as defined by FEV1 below the lower limit of normal | 1 day | 
| Presence of past history of AL/COPD | prevalence of documented evidence of COPD, chronic bronchitis or emphysema | 1 day | 
| COPD Assessment test™ (CAT) | Health status questionnaire on burden of airflow limitation (CAT) | 1 day | 
| Short Form 12 (SF12) | General health status questionnaire (SF12) | 1 day | 
| Cardiac Health Profile (CHP) | Health status questionnaire on burden of cardiac disease | 1 day | 
| Healthcare resource utilisation | Number of emergency room visits and hopsital admissions | within previous 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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prevalence, COPD, emphysema, co-morbidities, ischemic heart disease, chronic bronchitis, spirometry, burden