Is COPD a Risk Factor for Cardiovascular Disease? | NCT02162095

Studies
Is COPD a Risk Factor for Cardiovascular Disease?

NCT02162095

Sponsor

University of Zurich

Status

Completed

Last Update Posted

Jun 3, 2015Estimated

Enrollment

162Actual

Phase

Not provided

Conditions

Chronic Obstructive Pulmonary Disease

Interventions

Not provided

Countries

Switzerland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2014

Primary Completion Date

Dec 2014Actual

Completion Date

Dec 2014Actual

First Submitted Date

Jun 6, 2014

First Submission Date that Met QC Criteria

Jun 10, 2014

First Posted Date

Jun 12, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 2, 2015

Last Update Posted Date

Jun 3, 2015Estimated

Name	Class
University Hospital, Zürich	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

162Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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).

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
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
Major adverse cardiovascular events

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

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.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Malcolm Kohler, MD, Prof	University of Zurich	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Hospital Zurich, Pulmonary Division		Zurich	Canton of Zurich	8091	Switzerland

Condition Browse Module

MeSH Terms

ID	Term
D029424	Pulmonary Disease, Chronic Obstructive
D003324	Coronary Artery Disease

Ancestor Terms

ID	Term
D008173	Lung Diseases, Obstructive
D008171	Lung Diseases
D012140	Respiratory Tract Diseases
D002908	Chronic Disease

Browse Leaves

Not provided

Browse Branches

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