Cardiovascular DiseaseNCT01470274
Safety of the CO-rebreathing Method in Stable Coronary Artery Disease and COPD Patients
An observational study of Cardiovascular Disease and Chronic Obstructive Pulmonary Disease, run by Norwegian University of Science and Technology at 1 site in Norway.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Cardiovascular Disease, Chronic Obstructive Pulmonary Disease
- How many people
- 18 participants
- Where
- 1 siteNorway
- Study dates
- Nov 2011to Feb 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Stable, optimally medicated coronary artery disease and COPD patients with LVEF ≥ 0.40 will be recruited
Who may be able to join
- Stable coronary artery disease
- Stable COPD
- Optimal medication
Who cannot join
- Unstable disease
- co-morbidities
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Keywords
- Blood volume, CO-rebreathing, COPD, CVD
- Medical subject headings
- Cardiovascular Diseases, Pulmonary Disease, Chronic Obstructive
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2011 (estimated)
- Study startNov 2011
- Primary completionJan 2012
- Study completionFeb 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseaseStudies of the same condition, open and under way.
- More trials run by Norwegian University of Science and TechnologyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Norwegian University of Science and Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Trine Karlsen, PhD, Principal investigator, Norwegian University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01470274
- Sponsor's protocol ID
- 2011/1792
- Status last verified
- Jul 2016
- First submitted
- 9 Nov 2011
- Last updated
- 29 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 26672919
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety of the CO-rebreathing Method in Stable Coronary Artery Disease and COPD Patients
- ClinicalTrials.gov ID
- NCT01470274
- Acronym / sponsor ID
- 2011/1792
- Keywords
- Blood volume, CO-rebreathing, COPD, CVD
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Norwegian University of Science and TechnologyUniversity, hospital or other
- Study start
- Nov 2011
- Primary completion
- Jan 2012 (actual)
- Study completion
- Feb 2012 (actual)
- First posted
- 11 Nov 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Stable, optimally medicated coronary artery disease and COPD patients with LVEF ≥ 0.40 will be recruited
Key inclusion criteria (3 listed)
- Stable coronary artery disease
- Stable COPD
- Optimal medication
Key exclusion criteria (2 listed)
- Unstable disease
- co-morbidities
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2016.
- Results publication: PubMed 26672919Karlsen 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Trine Karlsen, PhD principal investigator
Norwegian University of Science and Technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiovascular Disease and Chronic Obstructive Pulmonary Disease, run by Norwegian University of Science and Technology at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01470274, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2016.