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Airflow Limitation in Cardiac Diseases in Europe (ALICE)

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ClinicalTrials.gov Identifier: NCT01485159
Recruitment Status : Completed
First Posted : December 5, 2011
Last Update Posted : February 24, 2014
Information provided by (Responsible Party):

Brief Summary:
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.

Condition or disease Intervention/treatment
Pulmonary Disease, Chronic Obstructive Procedure: Spirometry

Detailed Description:

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

Study Type : Observational
Actual Enrollment : 3000 participants
Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Airflow Limitation in Cardiac Diseases in Europe
Study Start Date : October 2011
Primary Completion Date : June 2012
Study Completion Date : June 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Diseases
U.S. FDA Resources

Group/Cohort Intervention/treatment
All subjects enrolled in the study
Procedure: Spirometry
assessment of lung function by spirometry

Primary Outcome Measures :
  1. Prevalence of Airflow Limitation [ Time Frame: 1 day ]
    Prevalence of AL as defined by Forced Expired Volume in 1 second (FEV1)/Forced Volume Capacity (FVC) < 0.70 (post bronchodilator)

Secondary Outcome Measures :
  1. Severity of AL [ Time Frame: 1 day ]
    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

  2. prevalence of restrictive AL [ Time Frame: 1 day ]
    Prevlence of restrictive AL FEV1/FVC ≥0.70 and a predicted FVC <80% (pre bronchodilator)

  3. Prevalence of AL [ Time Frame: 1 day ]
    Prevalence of AL as defined by FEV1 below the lower limit of normal

  4. Presence of past history of AL/COPD [ Time Frame: 1 day ]
    prevalence of documented evidence of COPD, chronic bronchitis or emphysema

  5. COPD Assessment test™ (CAT) [ Time Frame: 1 day ]
    Health status questionnaire on burden of airflow limitation (CAT)

  6. Short Form 12 (SF12) [ Time Frame: 1 day ]
    General health status questionnaire (SF12)

  7. Cardiac Health Profile (CHP) [ Time Frame: 1 day ]
    Health status questionnaire on burden of cardiac disease

  8. Healthcare resource utilisation [ Time Frame: within previous 12 months ]
    Number of emergency room visits and hopsital admissions

Biospecimen Retention:   Samples With DNA
In patients that specifically consent, blood samples will be taken for future analysis of the genetic links between COPD and cardiovascular disease

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients attending outpatient cardiology clinics with a history of Ischemic Heart Disease

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:

    1. Documented history of an Ischemic event,
    2. Current diagnosis of stable IHD (including history of acute Myocardial Infarction (MI) and angina pectoris) as diagnosed in accordance with ESC guidelines
    3. 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01485159

GSK Investigational Site
Gent, Belgium, 9000
GSK Investigational Site
Toulouse cedex 09, France, 31059
GSK Investigational Site
Neu-Isenburg, Hessen, Germany, 63263
GSK Investigational Site
Berlin, Germany, 13347
GSK Investigational Site
Thessaloniki, Greece, 570 10
GSK Investigational Site
Dublin, Ireland, 4
GSK Investigational Site
Dublin, Ireland, 9
GSK Investigational Site
Modena, Emilia-Romagna, Italy, 41124
GSK Investigational Site
Tradate (VA), Lombardia, Italy, 21049
GSK Investigational Site
Amersfoort, Netherlands, 3818 ES
GSK Investigational Site
Sneek, Netherlands, 8601 ZK
GSK Investigational Site
Madrid, Spain, 28046
GSK Investigational Site
Palma de Mallorca, Spain, 07010
GSK Investigational Site
Lund, Sweden, SE-222 21
GSK Investigational Site
Malmö, Sweden, SE-205 02
Sponsors and Collaborators
Study Director: GSK Clinical Trials GlaxoSmithKline

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01485159     History of Changes
Other Study ID Numbers: 115398
First Posted: December 5, 2011    Key Record Dates
Last Update Posted: February 24, 2014
Last Verified: February 2014

Keywords provided by GlaxoSmithKline:
ischemic heart disease
chronic bronchitis

Additional relevant MeSH terms:
Lung Diseases
Chronic Disease
Pulmonary Disease, Chronic Obstructive
Heart Diseases
Respiratory Tract Diseases
Disease Attributes
Pathologic Processes
Lung Diseases, Obstructive
Cardiovascular Diseases