Primary objective is to quantitatively assess differences in in vivo neuroinflammation in patients before and after coronary artery bypass grafting (CABG) surgery. Secondary objective is to study whether diffferences in in vivo neuroinflammation are…
ID
Source
Brief title
Condition
- Encephalopathies
- Cardiac therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Differences in PET tracer uptake before and after CABG.
Secondary outcome
Neuropsychological outcomes.
Background summary
Following coronary artery bypass grafting (CABG) surgery, patients have a
significantly increased risk for developing postoperative cognitive decline
(POCD). To date, the etiology of POCD is not understood. Neuroinflammation
plays an important role in the pathogenesis of neurodegenerative diseases. In
animal models and post-mortem studies systemic inflammation, as occurs after
cardiac surgery, can induce neuroinflammation. It is hypothesized that
neuroinflammation after cardiac surgery is an important factor to the
trajectory of postoperative cognitive decline after CABG.
Study objective
Primary objective is to quantitatively assess differences in in vivo
neuroinflammation in patients before and after coronary artery bypass grafting
(CABG) surgery.
Secondary objective is to study whether diffferences in in vivo
neuroinflammation are related to long term cognitive outcomes.
Study design
Observational time series design.
Study burden and risks
Screening and informed consent on the pre-operative outpatient's clinic of the
cardiothoracic surgery department and anesthesiology.
During hospital admission:
- questionnaires to assess pre-operative cognitive and functional state and
frailty.
- neuropsychological examination before CABG surgery (approximately 1-1.5
hours)
- PET-CT scan and MRI scan of the brain before CABG (total scan duration 90
minutes, radiation dose is 2x4.8 mSv which is below safety limits and
comparable to a normal abdominal CT-scan.
- Patients will undergo extra blood sampling three times, which will be
performed from pre-existent arterial or venous cannulas.
- One week after CABG, just before hospital discharge, patients will undergo
repeat PET-CT-scan and MRI and a neuropsychological exam.
After hospital admission:
- Follow-up at 6 weeks and 6 months after CABG surgery: neuropsychological
examination.
Geert Grooteplein Zuid 10
Nijmegen 6500 HB
NL
Geert Grooteplein Zuid 10
Nijmegen 6500 HB
NL
Listed location countries
Age
Inclusion criteria
Planned for coronary artery bypass grafting surgery (CABG)
Age > 50 years
High-affinity or mixed affinity binders based on rs6971 polymorphism for TSPO
Exclusion criteria
- Patients with cognitive disorders that have not recovered enough to be able to understand the study leaflets and information for participation.
- Pregnancy or wish to become pregnant within 2 weeks after PET-CT scan
- Contra-indication to undergo a PET/CT or MRI scan, including claustrophobia.
- Patients who undergo a combination of CABG surgery and additional valve surgery.
- Previous cardiac surgery.
- Low-affinity binder based on rs6971 polymorphism for TSPO, or unable to determine rs6971 polymorphism.
- Brain or spinal surgery within the last 6 months.
- Meningitis or brain infection within the last 6 months.
- Pre-existing dementia or neurodegenerative disease or cognitive impairment interfering with the ability to understand informational material about this research project.
- Presence of a CSF catheter or shunt.
- Patients with known brain tumors.
- Patients with brain injury (e.g. acute stroke, or subarachnoid hemorrhage) within the last 6 months.
- Severe brain trauma in previous medical history.
- Chronic (>2 weeks) use of immunosuppressive agents (see table 3.3.A).
- Concomitant diseases resulting in severe immunosuppression (e.g. HIV).
- Chronic use of neuroleptics, defined as pre-hospital use.
- Patients that do not speak Dutch or have disabilities that prevent accurate delirium diagnosis.
- Analphabetic patients.
- No written informed consent obtained.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2016-002016-40-NL |
| CCMO | NL57785.091.16 |