Plain English Summary
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
Trial website
Contact information
Type
Scientific
Primary contact
Dr Nikolai Stenfors
ORCID ID
Contact details
Jamtland County Council
Research and Development Unit
Building 10
5th floor
Östersund Hospital
Östersund
83183
Sweden
+46 63 153417
nikolai.stenfors@medicin.umu.se
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
The prevalence and significance of Chronic Obstructive Pulmonary disease in subjects with Acute Coronary Syndrome: an observational study
Acronym
COPACS
Study hypothesis
1. 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
Regional Ethical Review Board, Umeå University, Umeå, Sweden, 16/12/2009, ref: Dnr 09-142M
Study design
Single-centre observational study
Primary study design
Observational
Secondary study design
Cross sectional study
Trial setting
Hospitals
Trial type
Screening
Patient information sheet
Not available in web format, please use the contact details to request a patient information sheet
Condition
Chronic obstructive pulmonary disease, acute coronary syndrome
Intervention
The 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 type
Other
Phase
Not Applicable
Drug names
Primary outcome measure
1. 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 measures
In 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 trial start date
01/01/2010
Overall trial end date
31/12/2014
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. 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/)
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
350 subjects
Participant exclusion criteria
1. Dementia
2. Patients with severe disease
3. Subjects unable to perform adequate spirometry
Recruitment start date
01/01/2010
Recruitment end date
31/12/2014
Locations
Countries of recruitment
Sweden
Trial participating centre
Jamtland County Council
Östersund
83183
Sweden
Sponsor information
Organisation
Jämtland County Council (Sweden)
Sponsor details
Research & Development Unit
Building 10
5th floor
Östersund Hospital
Östersund
83183
Sweden
+46 63 142463
fou@jll.se
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
Jämtland County Council (Sweden)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Hjärt-Lungfonden
Alternative name(s)
Swedish Heart-Lung Foundation
Funding Body Type
private sector organisation
Funding Body Subtype
Trusts, charities, foundations (both publically funded and privately funded)
Location
Sweden
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/25415235