Is COPD a Risk Factor for Cardiovascular Disease?

Chronic Obstructive Pulmonary Disease Clinical Trial

Official title:

Is Chronic Obstructive Pulmonary Disease a Risk Factor for Cardiovascular Disease?

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02162095
• Other study ID #: SNCTP000000995
• Status: Completed
• Phase: N/A
• First received: June 6, 2014
• Last updated: June 2, 2015
• Start date: June 2014
• Est. completion date: December 2014

Study information

• Verified date: June 2015
• Source: University of Zurich
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Ethikkommission
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 162
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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 Design

Observational Model: Case Control, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Chronic Obstructive Pulmonary Disease
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Locations

Country	Name	City	State
Switzerland	University Hospital Zurich, Pulmonary Division	Zurich

Sponsors (2)

Lead Sponsor	Collaborator
University of Zurich	University Hospital, Zürich

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Coronary calcium score in cardiac computed tomography	Retrospective assessment of SPECT-CT imaging data at the University Hospital Zurich.	Up to one month	No
Secondary	Left ventricular ejection fraction in single-photon emission computed tomography	Retrospective assessment of SPECT-CT imaging data at the University Hospital Zurich.	Up to one month	No
Secondary	Major adverse cardiovascular events	Follow-up via telephone interview for major adverse cardiovascular events.	Up to three months	No