Condition category
Respiratory
Date applied
20/03/2012
Date assigned
04/05/2012
Last edited
14/02/2017
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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 measures

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

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

foundation

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

Results - basic reporting

Publication summary

2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/25415235

Publication citations

Additional files

Editorial Notes

14/02/2017: Plain English summary added.