Airflow Limitation in Cardiac Diseases in Europe

NCT01485159 | Completed

• 1 other identifier: 115398
• Study Type: observational
• Target: 3,000
• Locations: 9 countries
• Sites: 15

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.

Conditions

Pulmonary Disease, Chronic Obstructive

Keywords

prevalence; COPD; emphysema; co-morbidities; ischemic heart disease; chronic bronchitis; spirometry; burden

Outcome Measures

Primary Outcomes (1)

• Prevalence of Airflow Limitation

  Prevalence of AL as defined by Forced Expired Volume in 1 second (FEV1)/Forced Volume Capacity (FVC) \< 0.70 (post bronchodilator)

  1 day

Secondary Outcomes (8)

• Severity of AL

  1 day

• prevalence of restrictive AL

  1 day

• Prevalence of AL

  1 day

• Presence of past history of AL/COPD

  1 day

• COPD Assessment test™ (CAT)

  1 day

Study Arms (1)

All

All subjects enrolled in the study

Procedure: Spirometry

Interventions

Spirometry PROCEDURE

assessment of lung function by spirometry

All

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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:
• Documented history of an Ischemic event,
• Current diagnosis of stable IHD (including history of acute Myocardial Infarction (MI) and angina pectoris) as diagnosed in accordance with ESC guidelines
• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (15)

GSK Investigational Site

Ghent, 9000, Belgium

Location

GSK Investigational Site

Toulouse, 31059, France

Location

GSK Investigational Site

Neu-Isenburg, Hesse, 63263, Germany

Location

GSK Investigational Site

Berlin, State of Berlin, 13347, Germany

Location

GSK Investigational Site

Thessaloniki, 570 10, Greece

Location

GSK Investigational Site

Dublin, 4, Ireland

Location

GSK Investigational Site

Dublin, 9, Ireland

Location

GSK Investigational Site

Modena, Emilia-Romagna, 41124, Italy

Location

GSK Investigational Site

Tradate (VA), Lombardy, 21049, Italy

Location

GSK Investigational Site

Amersfoort, 3818 ES, Netherlands

Location

GSK Investigational Site

Sneek, 8601 ZK, Netherlands

Location

GSK Investigational Site

Madrid, 28046, Spain

Location

GSK Investigational Site

Palma de Mallorca, 07010, Spain

Location

GSK Investigational Site

Lund, SE-222 21, Sweden

Location

GSK Investigational Site

Malmo, SE-205 02, Sweden

Location

Related Publications (1)

• 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.

  PMID: 27442601 DERIVED

Biospecimen

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

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Emphysema; Myocardial Ischemia; Bronchitis, Chronic

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Bronchitis; Respiratory Tract Infections; Infections; Bronchial Diseases

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 17, 2011
• First Posted: December 5, 2011
• Study Start: October 1, 2011
• Primary Completion: June 1, 2012
• Study Completion: June 1, 2012
• Last Updated: February 24, 2014

Record last verified: 2014-02

Locations

FR (1); GR (1); SE (2); NL (2); ES (2); BE (1); IE (2); IT (2); DE (2)