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Is COPD a Risk Factor for Cardiovascular Disease?

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date June 6, 2014
First Posted Date June 12, 2014
Last Update Posted Date June 3, 2015
Study Start Date June 2014
Actual Primary Completion Date December 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 10, 2014)
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.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: June 10, 2014)
  • 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.
  • Major adverse cardiovascular events [ Time Frame: Up to three months ]
    Follow-up via telephone interview for major adverse cardiovascular events.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Is COPD a Risk Factor for Cardiovascular Disease?
Official Title Is Chronic Obstructive Pulmonary Disease a Risk Factor for Cardiovascular Disease?
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.

Study Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition Chronic Obstructive Pulmonary Disease
Intervention Not Provided
Study Groups/Cohorts
  • 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).
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: December 2, 2014)
162
Original Estimated Enrollment
 (submitted: June 10, 2014)
200
Actual Study Completion Date December 2014
Actual Primary Completion Date December 2014   (Final data collection date for primary outcome measure)
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.
Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Switzerland
Removed Location Countries  
 
Administrative Information
NCT Number NCT02162095
Other Study ID Numbers SNCTP000000995
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party University of Zurich
Study Sponsor University of Zurich
Collaborators University Hospital, Zürich
Investigators
Principal Investigator: Malcolm Kohler, MD, Prof University of Zurich
PRS Account University of Zurich
Verification Date June 2015