The prevalence and significance of chronic obstructive pulmonary disease in subjects with acute coronary syndrome

ISRCTN ISRCTN05697808
DOI https://doi.org/10.1186/ISRCTN05697808
Secondary identifying numbers N/A
Submission date
20/03/2012
Registration date
04/05/2012
Last edited
14/02/2017
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Respiratory
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Background and study aims
Chronic obstructive pulmonary disease (COPD) is a group of lung conditions that cause breathing difficulties. COPD shares a common risk factor, tobacco, with heart disease, which is currently the leading cause of death globally. Studies have found that patients with COPD have an increased risk of heart disease. However, these studies have several limitations. Firstly, the diagnosis of COPD has been based purely on medical records. Secondly, patients with asthma have sometimes also been included. As about 80% of patients with COPD are undiagnosed and 20-50% of patients with COPD do not fulfil the diagnostic criteria, the prevalence of COPD in heart disease has not been reliably assessed. Spirometry is a simple test that can be used to diagnose COPD by measuring how much air patients can breathe out in one forced breath. The aims of this study are to estimate the true prevalence of COPD in heart disease using spirometry, and to find out whether spirometry-verified COPD predicts heart disease prognosis.

Who can participate?
Patients hospitalised with heart disease (myocardial infarction or unstable angina), living in the county of Jämtland, Sweden

What does the study involve?
Participants’ lung volumes are measured (spirometry) during hospitalisation or at the first follow-up outpatient visit after discharge. The prevalence of spirometry-detected COPD is compared with the prevalence of COPD based on medical records.

What are the possible benefits and risks of participating?
If COPD is detected, participants receive disease information and, if needed, are offered treatment. The test requires forced expirations (breathing out). Some may experience slight physical discomfort during the test.

Where is the study run from?
Östersund Hospital (Sweden)

When is the study starting and how long is it expected to run for?
January 2010 to December 2014

Who is funding the study?
1. Jämtland County Council (Sweden)
2. The Swedish Heart and Lung Association (Sweden)

Who is the main contact?
Dr Nikolai Stenfors
nikolai stenfors@medicin.umu.se

Contact information

Dr Nikolai Stenfors
Scientific

Jamtland County Council
Research and Development Unit
Building 10, 5th floor
Östersund Hospital
Östersund
83183
Sweden

Phone +46 63 153417
Email nikolai.stenfors@medicin.umu.se

Study information

Study designSingle-centre observational study
Primary study designObservational
Secondary study designCross sectional study
Study setting(s)Hospital
Study typeScreening
Participant information sheet Not available in web format, please use the contact details to request a patient information sheet
Scientific titleThe prevalence and significance of Chronic Obstructive Pulmonary disease in subjects with Acute Coronary Syndrome: an observational study
Study acronymCOPACS
Study objectives1. Spirometry screening after acute coronary syndrom (ACS) will reveal that the majority of subjects with chronic obstructive pulmonary disease (COPD) are undiagnosed.
2. Spirometry-verified COPD is an independent predictor of death, reinfarction and stroke in subjects with Acute Coronary Syndrome (ACS).
Ethics approval(s)Regional Ethical Review Board, Umeå University, Umeå, Sweden, 16/12/2009, ref: Dnr 09-142M
Health condition(s) or problem(s) studiedChronic obstructive pulmonary disease, acute coronary syndrome
InterventionThe study subjects will be screened with spirometry to detect presence of chronic airflow limitation. Lung volume measurements (spirometry) will be done during the hospitalisation or at the first follow-up out-patient visit after discharge. Vital capacity (VC), forced vital capacity (FVC) and forced expiratory volume in one second (FEV1) will be measured before and after bronchodilation. FEV1/FVC <0.7 post bronchodilation will be considered as COPD.

The prevalence of spirometry-detected COPD will be compared with the prevalence of COPD based on medical records in the study population. We will evaluate whether spirometry-verified COPD predicts prognosis after ACS. Inclusion between 01 January 2010 and 30 June 2012, follow-up until 31 December 2014.
Intervention typeOther
Primary outcome measure1. The prevalence of spirometry-verified COPD versus medical-record based COPD in subjects with ACS
2. The adjusted hazard ratio of spirometry-verified COPD for death, reinfarction and stroke in subjects with ACS. Adjustment for age, gender, renal function, C-reactive protein, Killip class, previous myocardial infarction (MI), atrial fibrillation, coronary intervention, secondary preventive medication, diabetes, and smoking history.
Secondary outcome measuresIn subjects with ACS, spirometry-verified COPD is an independent predictor of hospital admissions (due to coronary angiography, percutaneous coronary intervention, coronary artery bypass surgery, angina, heart failure) and length of hospital stay.
Overall study start date01/01/2010
Completion date31/12/2014

Eligibility

Participant type(s)Patient
Age groupAdult
SexBoth
Target number of participants350 subjects
Key inclusion criteria1. All patients living in the county of Jämtland, Sweden, and hospitalised with a diagnosis of myocardial infarction or unstable angina will be assessed for inclusion
2. Östersund hospital is the only hospital in the county and all patients, terminal care excluded, with symptoms of a suspected acute coronary syndrome are referred for diagnostic evaluation
3. Study subjects are recruited in conjunction with the study "Secondary preventive, nurse based, telephone follow-up for risk factor control after an acute coronary syndrome" (http://www.isrctn.com/ISRCTN96595458/)
Key exclusion criteria1. Dementia
2. Patients with severe disease
3. Subjects unable to perform adequate spirometry
Date of first enrolment01/01/2010
Date of final enrolment31/12/2014

Locations

Countries of recruitment

  • Sweden

Study participating centre

Jamtland County Council
Östersund
83183
Sweden

Sponsor information

Jämtland County Council (Sweden)
Government

Research & Development Unit
Building 10, 5th floor
Östersund Hospital
Östersund
83183
Sweden

Phone +46 63 142463
Email fou@jll.se

Funders

Funder type

Government

Jämtland County Council (Sweden)

No information available

Hjärt-Lungfonden
Private sector organisation / Trusts, charities, foundations (both public and private)
Alternative name(s)
Swedish Heart-Lung Foundation
Location
Sweden

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/08/2015 Yes No

Editorial Notes

14/02/2017: Plain English summary added.