Airflow Limitation in Cardiac Diseases in Europe (ALICE)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01485159
First received: November 17, 2011
Last updated: February 20, 2014
Last verified: February 2014

November 17, 2011
February 20, 2014
October 2011
June 2012   (final data collection date for primary outcome measure)
Prevalence of Airflow Limitation [ Time Frame: 1 day ] [ Designated as safety issue: No ]
Prevalence of AL as defined by Forced Expired Volume in 1 second (FEV1)/Forced Volume Capacity (FVC) < 0.70 (post bronchodilator)
Same as current
Complete list of historical versions of study NCT01485159 on ClinicalTrials.gov Archive Site
  • Severity of AL [ Time Frame: 1 day ] [ Designated as safety issue: No ]
    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
  • prevalence of restrictive AL [ Time Frame: 1 day ] [ Designated as safety issue: No ]
    Prevlence of restrictive AL FEV1/FVC ≥0.70 and a predicted FVC <80% (pre bronchodilator)
  • Prevalence of AL [ Time Frame: 1 day ] [ Designated as safety issue: No ]
    Prevalence of AL as defined by FEV1 below the lower limit of normal
  • Presence of past history of AL/COPD [ Time Frame: 1 day ] [ Designated as safety issue: No ]
    prevalence of documented evidence of COPD, chronic bronchitis or emphysema
  • COPD Assessment test™ (CAT) [ Time Frame: 1 day ] [ Designated as safety issue: No ]
    Health status questionnaire on burden of airflow limitation (CAT)
  • Short Form 12 (SF12) [ Time Frame: 1 day ] [ Designated as safety issue: No ]
    General health status questionnaire (SF12)
  • Cardiac Health Profile (CHP) [ Time Frame: 1 day ] [ Designated as safety issue: No ]
    Health status questionnaire on burden of cardiac disease
  • Healthcare resource utilisation [ Time Frame: within previous 12 months ] [ Designated as safety issue: No ]
    Number of emergency room visits and hopsital admissions
Same as current
Not Provided
Not Provided
 
Airflow Limitation in Cardiac Diseases in Europe
Airflow Limitation in Cardiac Diseases in Europe

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.

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

Observational
Observational Model: Case-Only
Time Perspective: Cross-Sectional
Not Provided
Retention:   Samples With DNA
Description:

In patients that specifically consent, blood samples will be taken for future analysis of the genetic links between COPD and cardiovascular disease

Probability Sample

Patients attending outpatient cardiology clinics with a history of Ischemic Heart Disease

Pulmonary Disease, Chronic Obstructive
Procedure: Spirometry
assessment of lung function by spirometry
All
All subjects enrolled in the study
Intervention: Procedure: Spirometry
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
3000
June 2012
June 2012   (final data collection date for primary outcome measure)

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
Both
40 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Belgium,   France,   Germany,   Greece,   Ireland,   Italy,   Netherlands,   Spain,   Sweden
 
NCT01485159
115398
No
GlaxoSmithKline
GlaxoSmithKline
Not Provided
Study Director: GSK Clinical Trials GlaxoSmithKline
GlaxoSmithKline
February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP