Clinical trial NCT02162095: Is COPD a Risk Factor for Cardiovascular Disease?
Official title: Is Chronic Obstructive Pulmonary Disease a Risk Factor for Cardiovascular Disease?
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: Chronic obstructive pulmonary disease
Coronary artery disease
Coronary calcium score
Lead sponsor: University of Zurich
Sponsor class: OTHER
Collaborators: name: University Hospital, Zürich
First posted: 2014-06-12
Enrollment: 162
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with a history of smoking underdoing SPECT-CT imaging due to preoperative assessmentat the University Hospital Zurich between 01.01.2007 and 31.07.2013.

Brief summary: Patients with chronic obstructive pulmonary disease suffer from significant cardiovascular morbidity and mortality. This study wants to determine whether chronic obstructive pulmonary disease might be a risk factor for coronary atherosclerosis and other cardiac markers independent of conventional cardiovascular risk factors. The study is designed as a retrospective matched case-control study with follow-up via telephone interview.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Coronary calcium score in cardiac computed tomography
timeFrame: Up to one month
Secondary outcomes:
measure: Left ventricular ejection fraction in single-photon emission computed tomography
timeFrame: Up to one month
measure: Major adverse cardiovascular events
timeFrame: Up to three months
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: University Hospital Zurich, Pulmonary Division
Study officials:
affiliation: University of Zurich
name: Malcolm Kohler, MD, Prof
role: PRINCIPAL_INVESTIGATOR
References: