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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01470274
Recruitment Status : Completed
First Posted : November 11, 2011
Last Update Posted : July 29, 2016
Sponsor:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease
Cardiovascular Disease Chronic Obstructive Pulmonary Disease

Study Design

Study Type : Observational
Actual Enrollment : 18 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Safety of the CO-rebreathing Method in Stable Coronary Artery Disease and COPD Patients
Study Start Date : November 2011
Primary Completion Date : January 2012
Study Completion Date : February 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts


Outcome Measures

Biospecimen Retention:   Samples Without DNA
Blood samples

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Stable, optimally medicated coronary artery disease and COPD patients with LVEF ≥ 0.40 will be recruited
Criteria

Inclusion Criteria:

  • Stable coronary artery disease
  • Stable COPD
  • Optimal medication

Exclusion Criteria:

  • Unstable disease
  • co-morbidities
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01470274


Locations
Norway
Norwegian University of Science and Technology
Trondheim, Norway, 7489
Sponsors and Collaborators
Norwegian University of Science and Technology
Investigators
Principal Investigator: Trine Karlsen, PhD Norwegian University of Science and Technology
More Information

Publications:
Responsible Party: Norwegian University of Science and Technology
ClinicalTrials.gov Identifier: NCT01470274     History of Changes
Other Study ID Numbers: 2011/1792
First Posted: November 11, 2011    Key Record Dates
Last Update Posted: July 29, 2016
Last Verified: July 2016

Keywords provided by Norwegian University of Science and Technology:
Blood volume
CO-rebreathing
COPD
CVD

Additional relevant MeSH terms:
Lung Diseases
Cardiovascular Diseases
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases
Heart Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases