Is COPD a Risk Factor for Cardiovascular Disease?

NCT ID: NCT02162095

Last Updated: 2015-06-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

162 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-06-30

Study Completion Date

2014-12-31

Brief Summary

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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

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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.

Conditions

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Chronic Obstructive Pulmonary Disease

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Study Groups

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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).

No interventions assigned to this group

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).

No interventions assigned to this group

Eligibility Criteria

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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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Zürich

OTHER

Sponsor Role collaborator

University of Zurich

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Malcolm Kohler, MD, Prof

Role: PRINCIPAL_INVESTIGATOR

University of Zurich

Locations

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University Hospital Zurich, Pulmonary Division

Zurich, Canton of Zurich, Switzerland

Site Status

Countries

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Switzerland

Other Identifiers

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SNCTP000000995

Identifier Type: -

Identifier Source: org_study_id

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