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Is COPD a Risk Factor for Cardiovascular Disease?

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ClinicalTrials.gov Identifier: NCT02162095
Recruitment Status : Completed
First Posted : June 12, 2014
Last Update Posted : June 3, 2015
Sponsor:
Collaborator:
University Hospital, Zürich
Information provided by (Responsible Party):
University of Zurich

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.

Condition or disease
Chronic Obstructive Pulmonary Disease

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 : Observational
Actual Enrollment : 162 participants
Observational Model: Case Control
Time Perspective: Retrospective
Official Title: Is Chronic Obstructive Pulmonary Disease a Risk Factor for Cardiovascular Disease?
Study Start Date : June 2014
Actual Primary Completion Date : December 2014
Actual Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: COPD Lung Diseases

Group/Cohort
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).
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).



Primary Outcome Measures :
  1. Coronary calcium score in cardiac computed tomography [ Time Frame: Up to one month ]
    Retrospective assessment of SPECT-CT imaging data at the University Hospital Zurich.


Secondary Outcome Measures :
  1. Left ventricular ejection fraction in single-photon emission computed tomography [ Time Frame: Up to one month ]
    Retrospective assessment of SPECT-CT imaging data at the University Hospital Zurich.

  2. Major adverse cardiovascular events [ Time Frame: Up to three months ]
    Follow-up via telephone interview for major adverse cardiovascular events.



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02162095


Locations
Switzerland
University Hospital Zurich, Pulmonary Division
Zurich, Switzerland, 8091
Sponsors and Collaborators
University of Zurich
University Hospital, Zürich
Investigators
Principal Investigator: Malcolm Kohler, MD, Prof University of Zurich

Responsible Party: University of Zurich
ClinicalTrials.gov Identifier: NCT02162095     History of Changes
Other Study ID Numbers: SNCTP000000995
First Posted: June 12, 2014    Key Record Dates
Last Update Posted: June 3, 2015
Last Verified: June 2015

Keywords provided by University of Zurich:
Chronic obstructive pulmonary disease
Coronary artery disease
Coronary calcium score

Additional relevant MeSH terms:
Lung Diseases
Cardiovascular Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases