NCT01470274

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
18

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Nov 2011

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

November 1, 2011

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

November 9, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 11, 2011

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2012

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2012

Completed
Last Updated

July 29, 2016

Status Verified

July 1, 2016

Enrollment Period

2 months

First QC Date

November 9, 2011

Last Update Submit

July 28, 2016

Conditions

Cardiovascular DiseaseChronic Obstructive Pulmonary Disease

Keywords

Blood volumeCO-rebreathingCOPDCVD

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • Stable coronary artery disease
  • Stable COPD
  • Optimal medication

You may not qualify if:

  • Unstable disease
  • co-morbidities

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Norwegian University of Science and Technology

Trondheim, 7489, Norway

Location

Related Publications (1)

  • 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.

    PMID: 26672919RESULT

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood samples

MeSH Terms

Conditions

Cardiovascular DiseasesPulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Trine Karlsen, PhD

    Norwegian University of Science and Technology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 9, 2011

First Posted

November 11, 2011

Study Start

November 1, 2011

Primary Completion

January 1, 2012

Study Completion

February 1, 2012

Last Updated

July 29, 2016

Record last verified: 2016-07

Locations

NO(1)