- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02162095
Is COPD a Risk Factor for Cardiovascular Disease?
Is Chronic Obstructive Pulmonary Disease a Risk Factor for Cardiovascular Disease?
Study Overview
Status
Conditions
Detailed Description
Patients with chronic obstructive pulmonary disease (COPD) suffer from significant cardiovascular morbidity and mortality. Coronary artery disease has often been linked causally to COPD, but the exact pathophysiological mechanisms underpinning this association remain speculative. A retrospective case-control study matching COPD patients and controls one to one for smoking history and conventional cardiovascular risk factors will be performed to study the association between COPD and cardiovascular outcomes. Filling in this knowledge gap may contribute to the understanding of the interplay between COPD and cardiovascular disease.
The objective of this retrospective case-control study is to determine whether COPD might be a risk factor for coronary atherosclerosis, impaired left ventricular ejection fraction, and major adverse cardiovascular events independent of conventional cardiovascular risk factors.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Zurich, Switzerland, 8091
- University Hospital Zurich, Pulmonary Division
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- SPECT-CT imaging due to preoperative assessment between 01.01.2007 and 31.07.2013.
- Coronary artery calcium score and left ventricular ejection fraction data available.
- History of smoking (smoker or ex-smoker).
- COPD group: Documented chronic obstructive pulmonary disease (post-bronchodilator FEV1/FVC < 0.7).
- Control group: Exclusion of chronic obstructive pulmonary disease (post-bronchodilator FEV1/FVC > 0.7).
Exclusion Criteria:
- Known coronary artery disease or coronary symptoms (angina pectoris) at the time of the SPECT-CT investigation.
- Known congenital or structural heart disease.
- Previous heart transplantation.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Chronic obstructive pulmonary disease
Approximately 100 participants with documented chronic obstructive pulmonary disease (post-bronchodilator Forced expiratory volume in 1 second (FEV1)/Forced vital capacity (FVC) < 0.7).
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Control
Approximately 100 participants with exclusion of chronic obstructive pulmonary disease (post-bronchodilator Forced expiratory volume in 1 second (FEV1)/Forced vital capacity (FVC) > 0.7).
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Coronary calcium score in cardiac computed tomography
Time Frame: Up to one month
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Retrospective assessment of SPECT-CT imaging data at the University Hospital Zurich.
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Up to one month
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Left ventricular ejection fraction in single-photon emission computed tomography
Time Frame: Up to one month
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Retrospective assessment of SPECT-CT imaging data at the University Hospital Zurich.
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Up to one month
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Major adverse cardiovascular events
Time Frame: Up to three months
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Follow-up via telephone interview for major adverse cardiovascular events.
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Up to three months
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Malcolm Kohler, MD, Prof, University of Zurich
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SNCTP000000995
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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