Chronic Obstructive Pulmonary Disease as a Predictor of M... | NCT02392065

Studies
Chronic Obstructive Pulmonary Disease as a Predictor of Mortality in Cardiac Surgery

NCT02392065

Sponsor

Meshalkin Research Institute of Pathology of Circulation

Status

Unknown status

Last Update Posted

Mar 16, 2016Estimated

Enrollment

1,100Estimated

Phase

Not provided

Conditions

Chronic Obstructive Pulmonary Disease
Cardiac Surgery

Interventions

Not provided

Countries

Russia

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

Mar 2016

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2015

Primary Completion Date

Mar 2018Estimated

Completion Date

Mar 2018Estimated

First Submitted Date

Mar 12, 2015

First Submission Date that Met QC Criteria

Mar 12, 2015

First Posted Date

Mar 18, 2015Estimated

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

Mar 14, 2016

Last Update Posted Date

Mar 16, 2016Estimated

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

To estimate prevalence of chronic obstructive pulmonary disease (COPD) in cardiac surgery population and establish links between COPD status, as assessed through pulmonary functional tests, and 2-year mortality

Detailed Description

Not provided

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

1,100Estimated

Measure	Description	Time Frame
All-cause mortality		Two years

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

written informed consent, planned elective coronary artery bypass graft surgery

Exclusion Criteria:

contraindications to pulmonary functional tests, emergency surgery, recent or ongoing myocardial infarction, angina

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

All patients scheduled for coronary artery bypass surgery during one year will be screened and approached

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Dmitry Ponomarev, MD, MSc	Contact	+79232339205		d_ponomarev@meshalkin.ru

Overall Officials

Name	Affiliation	Role
Vladimir Lomivorotov, MD, PhD	Novosibisrk Research Institute of Circulation Pathology	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Novosibirsk Research Institute of Circulation Pathology	Recruiting	Novosibirsk		630055	Russia

Condition Browse Module

MeSH Terms

ID	Term
D029424	Pulmonary Disease, Chronic Obstructive

Ancestor Terms

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

Browse Leaves

Not provided

Browse Branches

Not provided