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

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Norwegian University of Science and Technology

ClinicalTrials.gov Identifier:

NCT01470274

First received: November 9, 2011

Last updated: July 28, 2016

Last verified: July 2016

History of Changes

Purpose

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
Cardiovascular Disease Chronic Obstructive Pulmonary Disease


Study Type:	Observational
Study Design:	Observational Model: Cohort Time Perspective: Prospective
Official Title:	Safety of the CO-rebreathing Method in Stable Coronary Artery Disease and COPD Patients

Resource links provided by NLM:

MedlinePlus related topics: Coronary Artery Disease

U.S. FDA Resources

Further study details as provided by Norwegian University of Science and Technology:

Biospecimen Retention: Samples Without DNA

Blood samples


Enrollment:	18
Study Start Date:	November 2011
Study Completion Date:	February 2012
Primary Completion Date:	January 2012 (Final data collection date for primary outcome measure)

Eligibility


Ages Eligible for Study:	18 Years to 75 Years (Adult, Senior)
Genders Eligible for Study:	Both
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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:

Karlsen T, Leinan IM, Aamot IL, Dalen H, Støylen 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.


Responsible Party:	Norwegian University of Science and Technology
ClinicalTrials.gov Identifier:	NCT01470274 History of Changes
Other Study ID Numbers:	2011/1792
Study First Received:	November 9, 2011
Last Updated:	July 28, 2016
Health Authority:	Norway: Regional Ethics Commitee

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

ClinicalTrials.gov processed this record on September 28, 2016

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