Safety of the CO-rebreathing Method in Stable Coronary Ar... | NCT01470274

Studies
Safety of the CO-rebreathing Method in Stable Coronary Artery Disease and COPD Patients

NCT01470274

Sponsor

Norwegian University of Science and Technology

Status

Completed

Last Update Posted

Jul 29, 2016Estimated

Enrollment

18Actual

Phase

Not provided

Conditions

Cardiovascular Disease
Chronic Obstructive Pulmonary Disease

Interventions

Not provided

Countries

Norway

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

Jul 2016

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

Nov 2011

Primary Completion Date

Jan 2012Actual

Completion Date

Feb 2012Actual

First Submitted Date

Nov 9, 2011

First Submission Date that Met QC Criteria

Nov 10, 2011

First Posted Date

Nov 11, 2011Estimated

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

Jul 28, 2016

Last Update Posted Date

Jul 29, 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

The primary objective is to establish the safety of the CO-rebreathing method for measuring total blood and plasma volume in CAD patients. The working hypothesis is that the CO-rebreathing method is safe in use with coronary artery disease patients and that it does not cause myocardial ischemia or cardiovascular damage.

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

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

18Actual

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Stable coronary artery disease
Stable COPD
Optimal medication

Exclusion Criteria:

Unstable disease
co-morbidities

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Stable, optimally medicated coronary artery disease and COPD patients with LVEF ≥ 0.40 will be recruited

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Trine Karlsen, PhD	Norwegian University of Science and Technology	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Norwegian University of Science and Technology		Trondheim		7489	Norway

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
26672919	Result	Karlsen T, Leinan IM, Aamot IL, Dalen H, Stoylen A. Safety of the CO-Rebreathing Method in Patients with Coronary Artery Disease. Med Sci Sports Exerc. 2016 Jan;48(1):33-8. doi: 10.1249/MSS.0000000000000729.

ID	Term
D002318	Cardiovascular Diseases
D029424	Pulmonary Disease, Chronic Obstructive

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