NCT02162095

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
162

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2014

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2014

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

June 6, 2014

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 12, 2014

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

June 3, 2015

Status Verified

June 1, 2015

Enrollment Period

6 months

First QC Date

June 6, 2014

Last Update Submit

June 2, 2015

Conditions

Keywords

Chronic obstructive pulmonary diseaseCoronary artery diseaseCoronary calcium score

Outcome Measures

Primary Outcomes (1)

  • Coronary calcium score in cardiac computed tomography

    Retrospective assessment of SPECT-CT imaging data at the University Hospital Zurich.

    Up to one month

Secondary Outcomes (2)

  • Left ventricular ejection fraction in single-photon emission computed tomography

    Up to one month

  • Major adverse cardiovascular events

    Up to three months

Study Arms (2)

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).

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Zurich, Pulmonary Division

Zurich, Canton of Zurich, 8091, Switzerland

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic ObstructiveCoronary Artery Disease

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsCoronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Study Officials

  • Malcolm Kohler, MD, Prof

    University of Zurich

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 6, 2014

First Posted

June 12, 2014

Study Start

June 1, 2014

Primary Completion

December 1, 2014

Study Completion

December 1, 2014

Last Updated

June 3, 2015

Record last verified: 2015-06

Locations