Airflow Limitation in Cardiac Diseases in Europe (ALICE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01485159
Recruitment Status : Completed
First Posted : December 5, 2011
Last Update Posted : February 24, 2014
Information provided by (Responsible Party):

November 17, 2011
December 5, 2011
February 24, 2014
October 2011
June 2012   (Final data collection date for primary outcome measure)
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)
Same as current
Complete list of historical versions of study NCT01485159 on Archive Site
  • 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
  • prevalence of restrictive AL [ Time Frame: 1 day ]
    Prevlence of restrictive AL FEV1/FVC ≥0.70 and a predicted FVC <80% (pre bronchodilator)
  • Prevalence of AL [ Time Frame: 1 day ]
    Prevalence of AL as defined by FEV1 below the lower limit of normal
  • Presence of past history of AL/COPD [ Time Frame: 1 day ]
    prevalence of documented evidence of COPD, chronic bronchitis or emphysema
  • COPD Assessment test™ (CAT) [ Time Frame: 1 day ]
    Health status questionnaire on burden of airflow limitation (CAT)
  • Short Form 12 (SF12) [ Time Frame: 1 day ]
    General health status questionnaire (SF12)
  • Cardiac Health Profile (CHP) [ Time Frame: 1 day ]
    Health status questionnaire on burden of cardiac disease
  • Healthcare resource utilisation [ Time Frame: within previous 12 months ]
    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 Model: Case-Only
Time Perspective: Cross-Sectional
Not Provided
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
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 subjects enrolled in the study
Intervention: Procedure: Spirometry
Franssen FM, Soriano JB, Roche N, Bloomfield PH, Brusselle G, Fabbri LM, García-Rio F, Kearney MT, Kwon N, Lundbäck B, Rabe KF, Raillard A, Muellerova H, Cockcroft JR. Lung Function Abnormalities in Smokers with Ischemic Heart Disease. Am J Respir Crit Care Med. 2016 Sep 1;194(5):568-76. doi: 10.1164/rccm.201512-2480OC.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Same as current
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
Sexes Eligible for Study: All
40 Years and older   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
Belgium,   France,   Germany,   Greece,   Ireland,   Italy,   Netherlands,   Spain,   Sweden
Not Provided
Not Provided
Not Provided
Study Director: GSK Clinical Trials GlaxoSmithKline
February 2014