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Airflow Limitation in Cardiac Diseases in Europe (the ALICE study).

Airflow Limitation in Cardiac Diseases in Europe (the ALICE study). - ALICE

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON35465
Enrollment
400
Registered
2011-10-04
Start date
2011-11-01
Completion date
Unknown
Last updated
2024-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COPD Ischemic Heart Disease

Interventions

None listed

Sponsors

GlaxoSmithKline
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: 1. Subjects aged >=40 years; 2. Current or former smokers with >=10 pack years; 3. Subjects attending outpatient cardiac clinic (or equivalent) fulfilling any of the following criteria: a. Documented history of an Ischemic event, b. Current diagnosis of stable IHD (including history of acute Myocardial Infarction'(MI) and angina pectoris) as diagnosed in accordance with ESC guidelines c. Receiving regular therapy for IHD for >1yr, 4. Subjects willing and able to sign study consent form.

Exclusion criteria

Exclusion criteria: 1. Subjects for whom spirometry is contraindicated (e.g. with detached retina, active tuberculosis, last trimester of pregnancy, resting pulse >120 etc); 2. Subjects with recent surgery or MI (within 1 month); lower respiratory tract infection or pneumothorax (within 2 months); or stroke (within 12 months); 3. Subjects with a pre-existing condition which, in the opinion of the investigator, would compromise the safety of the subject in this study.

Design outcomes

Primary

MeasureTime frame
Airflow Limitation, defined by FEV1/Forced Volume Capacity (FVC)

Secondary

MeasureTime frame
• Severity of airflow limitation, as defined by GOLD stages • Restrictive airflow limitation, defined by FEV1/FVC >=0.70 and a predicted FVC

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)