Last updated: 10/23/2020 08:30:04
Airflow Limitation in Cardiac Diseases in EuropeALICE
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Finalized
Finalized
Trial overview
Official title: Airflow Limitation in Cardiac Diseases in Europe
Trial description: 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.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Prevalence of Airflow Limitation
Timeframe: 1 day
Secondary outcomes:
Severity of AL
Timeframe: 1 day
prevalence of restrictive AL
Timeframe: 1 day
Prevalence of AL
Timeframe: 1 day
Presence of past history of AL/COPD
Timeframe: 1 day
COPD Assessment test™ (CAT)
Timeframe: 1 day
Short Form 12 (SF12)
Timeframe: 1 day
Cardiac Health Profile (CHP)
Timeframe: 1 day
Healthcare resource utilisation
Timeframe: within previous 12 months
Interventions:
Procedure/surgery: Spirometry
Enrollment:
3000
Observational study model:
Case-Only
Primary completion date:
2012-29-06
Time perspective:
Cross-Sectional
Clinical publications:
Not applicable
Medical condition
Pulmonary Disease, Chronic Obstructive
Product
Not applicable
Collaborators
Not applicable
Study date(s)
October 2011 to June 2012
Type
Observational
Phase
Not applicable
Participation criteria
Sex
Female & Male
Age
40+ years
Accepts healthy volunteers
No
- Subjects aged ≥40 years;
- Current or former smokers with ≥10 pack years;
- 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);
Inclusion and exclusion criteria
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: 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, 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
Trial location(s)
Study documents
Protocol
Available language(s): English
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Finalized
Actual primary completion date
2012-29-06
Actual study completion date
2012-29-06
Plain language summaries
Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.
Additional information about the trial
Not applicable
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