Ischemic Heart DiseaseNCT02941380
Exploration of Cerebral Pathophysiology During and After CABG Using CPB
An observational study of Ischemic Heart Disease, run by Copenhagen University Hospital, Rigshospitalet.
Trial summary
Purpose: The purpose of this study is to examine cerebral oxidative and inflammatory stress and cerebral hemodynamics during and after coronary artery bypass grafting and correlate with postoperative cognitive function. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Ischemic Heart Disease
- How many people
- 24 participants
- Where
- No sites listed yet
- Study dates
- Jul 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with ischemic heart disease admitted for coronary artery bypass grafting with the use of cardiopulmonary bypass
Who may be able to join
- Patients with ischemic heart disease admitted for coronary artery bypass grafting with the use of cardiopulmonary bypass
Who cannot join
- Cerebrovascular disease
About this study
Official title: Cerebral Oxidative and Inflammatory Stress and Cerebral Hemodynamics During and After Coronary Artery Bypass Grafting With Use of Cardiopulmonary Bypass
Purpose:
The purpose of this study is to examine cerebral oxidative and inflammatory stress and cerebral hemodynamics during and after coronary artery bypass grafting and correlate with postoperative cognitive function.
Read the detailed description
Postoperative cognitive decline is a well-known and well-described complication following coronary artery bypass grafting. Severity ranges from postoperative delirium to stroke, but the majority of patients with postoperative cognitive decline following coronary artery bypass grafting have decline in recent and remote memory in particular.
The reason for the cognitive decline is still not fully understood though many reasons have been proposed.
Inflammation and oxidative stress may contribute to the postoperative cognitive dysfunction which may also be in combination with a reduced cerebral autoregulation.
- Conditions
- Ischemic Heart Disease
- Keywords
- coronary artery bypass grafting, cardiopulmonary bypass, Cerebral oxidative stress, Cerebral inflammatory stress, Cerebral hemodynamics, Postoperative cognitive dysfunction
- Medical subject headings
- Myocardial Ischemia, Postoperative Cognitive Complications
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 |
|---|---|---|
| Ischemic heart disease | Patients admitted for coronary artery bypass grafting with the use of cardiopulmonary bypass |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cerebral autoregulation
Flow measurement of middle cerebral artery and measurement of middel arterial pressure
Measured: 6 hours post operation
Secondary outcomes (1)
Postoperative cognitive function
Measured: One day prior to operation and three days after operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2016 (estimated)
- Study startJul 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.
- Other trials for Ischemic Heart DiseaseStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe 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
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Claus Behrend Christiansen, Copenhagen University Hospital, Rigshospitalet
- Investigators
- Kirsten Møller, MD PhD DMSc, Study director, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02941380
- Sponsor's protocol ID
- H-4-2011-037
- Status last verified
- Oct 2016
- First submitted
- 29 Apr 2016
- Last updated
- 21 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cerebral Oxidative and Inflammatory Stress and Cerebral Hemodynamics During and After Coronary Artery Bypass Grafting With Use of Cardiopulmonary Bypass
- ClinicalTrials.gov ID
- NCT02941380
- Acronym / sponsor ID
- H-4-2011-037
- Conditions
- Ischemic Heart Disease
- Keywords
- coronary artery bypass grafting, cardiopulmonary bypass, Cerebral oxidative stress, Cerebral inflammatory stress, Cerebral hemodynamics, Postoperative cognitive dysfunction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Study start
- Jul 2011
- Primary completion
- Jan 2012 (actual)
- Study completion
- Feb 2012 (actual)
- First posted
- 21 Oct 2016 (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.
Purpose:
The purpose of this study is to examine cerebral oxidative and inflammatory stress and cerebral hemodynamics during and after coronary artery bypass grafting and correlate with postoperative cognitive function.
Detailed description
Postoperative cognitive decline is a well-known and well-described complication following coronary artery bypass grafting. Severity ranges from postoperative delirium to stroke, but the majority of patients with postoperative cognitive decline following coronary artery bypass grafting have decline in recent and remote memory in particular.
The reason for the cognitive decline is still not fully understood though many reasons have been proposed.
Inflammation and oxidative stress may contribute to the postoperative cognitive dysfunction which may also be in combination with a reduced cerebral autoregulation.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ischemic heart disease | – | –Patients admitted for coronary artery bypass grafting with the use of cardiopulmonary bypass |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with ischemic heart disease admitted for coronary artery bypass grafting with the use of cardiopulmonary bypass
Key inclusion criteria (1 listed)
- Patients with ischemic heart disease admitted for coronary artery bypass grafting with the use of cardiopulmonary bypass
Key exclusion criteria (1 listed)
- Cerebrovascular disease
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 autoregulation
Time frame: 6 hours post operation
Flow measurement of middle cerebral artery and measurement of middel arterial pressure
1 secondary outcome
Postoperative cognitive function
Time frame: One day prior to operation and three days after operation
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 21 Oct 2016.
- Individual participant dataSharing planned: No
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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.
Kirsten Møller, MD PhD DMSc study director
Copenhagen University Hospital, Rigshospitalet
Questions about this trial
What is this clinical trial studying?
An observational study of Ischemic Heart Disease, run by Copenhagen University Hospital, Rigshospitalet.
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 1 inclusion and 1 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 21 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
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 autoregulation (time frame: 6 hours post operation). 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 21 Oct 2016; AzTrials last refreshed its copy on 6 Nov 2026.