Airflow Limitation in Cardiac Diseases in Europe

NCT ID: NCT01485159

Last Updated: 2014-02-24

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 3000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2011-10-31
• Study Completion Date: 2012-06-30

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.

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

Conditions

Pulmonary Disease, Chronic Obstructive

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

All

All subjects enrolled in the study

Spirometry

Intervention Type: PROCEDURE

assessment of lung function by spirometry

Interventions

Spirometry

assessment of lung function by spirometry

Intervention Type: PROCEDURE

Eligibility 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:

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

• Minimum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

GSK Investigational Site

Ghent, , Belgium

GSK Investigational Site

Toulouse, , France

GSK Investigational Site

Neu-Isenburg, Hesse, Germany

GSK Investigational Site

Berlin, State of Berlin, Germany

GSK Investigational Site

Thessaloniki, , Greece

GSK Investigational Site

Dublin, , Ireland

GSK Investigational Site

Dublin, , Ireland

GSK Investigational Site

Modena, Emilia-Romagna, Italy

GSK Investigational Site

Tradate (VA), Lombardy, Italy

GSK Investigational Site

Amersfoort, , Netherlands

GSK Investigational Site

Sneek, , Netherlands

GSK Investigational Site

Madrid, , Spain

GSK Investigational Site

Palma de Mallorca, , Spain

GSK Investigational Site

Lund, , Sweden

GSK Investigational Site

Malmo, , Sweden

Countries

Belgium; France; Germany; Greece; Ireland; Italy; Netherlands; Spain; Sweden

References

Franssen FM, Soriano JB, Roche N, Bloomfield PH, Brusselle G, Fabbri LM, Garcia-Rio F, Kearney MT, Kwon N, Lundback 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.

Reference Type: DERIVED

PMID: 27442601 (View on PubMed)

Other Identifiers

115398

Identifier Type: -

Identifier Source: org_study_id