Coronary Artery Disease.Co-HLMNCT01940874
Cerebral Oxymetry at Elective Coronary and Valve Surgery.
An observational study of Coronary Artery Disease. and Aortic Valve Stenosis., run by Oslo University Hospital at 1 site in Norway.
Trial summary
Use of vasopressor to maintain Mean Arterial Pressure on Cardio Pulmonary Bypass can lead to decreased cerebral flow and oxygenation in individual patients and this can be detected by means of cerebral oxymetry. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Coronary Artery Disease., Aortic Valve Stenosis., Aortic Valve Regurgitation.
- How many people
- 54 participants
- Where
- 1 siteNorway
- Study dates
- Feb 2011to Mar 2013
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: We want to include 50 patients, both women and men, undergo elective coronary bypass surgery or valve surgeon in CPB with moderate hypothermia.
Who may be able to join
- Patient age under 80.
- Patients should undergo elective coronary artery bypass grafting surgery (ACB) or heart valve surgery (AVR or MVR).
- The patient must be admitted at least 18 years of years.
Who cannot join
- Damage to the frontal lobes corresponding to the area where SCO2 monitored.
- Patients in pharmacological studies.
- Patients with known intracranial vascular anomalies or cerebral aneurysms.
- Patients with known neurological disease.
- Patients with known undergone cerebral insult, TIA or carotid stenosis.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Cerebral Oxymetry at Elective Coronary and Valve Surgery: An Observational Study Using Norepinephrine to Maintain Arterial Blood Pressure on Cardio Pulmonary Bypass.
Use of vasopressor to maintain Mean Arterial Pressure on Cardio Pulmonary Bypass can lead to decreased cerebral flow and oxygenation in individual patients and this can be detected by means of cerebral oxymetry.
- Keywords
- Cerebral Oximetry., Aortic valve stenosis., Aortic valve regurgitation., Coronary artery disease.
- Medical subject headings
- Coronary Artery Disease, Aortic Valve Stenosis, Aortic Valve Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Cerebral oximetry | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cerebral oxymetry values
Measured: March 2013
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2013 (estimated)
- Study startFeb 2011
- Primary completionMar 2013
- Study completionMar 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery Disease.Studies of the same condition, open and under way.
- More trials run by Oslo University HospitalThe 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
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ove A. Hagen, MD, Principal investigator, Oslo Ùniversity Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01940874
- Sponsor's protocol ID
- 2010/823
- Acronym
- Co-HLM
- Status last verified
- Oct 2013
- First submitted
- 9 Sep 2013
- Last updated
- 9 Oct 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cerebral Oxymetry at Elective Coronary and Valve Surgery: An Observational Study Using Norepinephrine to Maintain Arterial Blood Pressure on Cardio Pulmonary Bypass.
- ClinicalTrials.gov ID
- NCT01940874
- Acronym / sponsor ID
- Co-HLM / 2010/823
- Keywords
- Cerebral Oximetry., Aortic valve stenosis., Aortic valve regurgitation., Coronary artery disease.
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Study start
- Feb 2011
- Primary completion
- Mar 2013 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 12 Sep 2013 (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.
Use of vasopressor to maintain Mean Arterial Pressure on Cardio Pulmonary Bypass can lead to decreased cerebral flow and oxygenation in individual patients and this can be detected by means of cerebral oxymetry.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cerebral oximetry | – | – |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- We want to include 50 patients, both women and men, undergo elective coronary bypass surgery or valve surgeon in CPB with moderate hypothermia.
Key inclusion criteria (3 listed)
- Patient age under 80.
- Patients should undergo elective coronary artery bypass grafting surgery (ACB) or heart valve surgery (AVR or MVR).
- The patient must be admitted at least 18 years of years.
Key exclusion criteria (5 listed)
- Damage to the frontal lobes corresponding to the area where SCO2 monitored.
- Patients in pharmacological studies.
- Patients with known intracranial vascular anomalies or cerebral aneurysms.
- Patients with known neurological disease.
- Patients with known undergone cerebral insult, TIA or carotid stenosis.
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
Cerebral oxymetry values
Time frame: March 2013
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 9 Oct 2013.
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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.
Ove A. Hagen, MD principal investigator
Oslo Ùniversity Hospital
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 Coronary Artery Disease. and Aortic Valve Stenosis., run by Oslo University Hospital 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 5 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 9 Oct 2013. 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.
What does the primary outcome measure?
Cerebral oxymetry values (time frame: March 2013). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Oct 2013; AzTrials last refreshed its copy on 31 Oct 2026.