Status:
COMPLETED
Neuroinflammation in Cognitive Decline Post-cardiac Surgery
Lead Sponsor:
Radboud University Medical Center
Conditions:
Postoperative Cognitive Dysfunction
Coronary Artery Disease
Eligibility:
All Genders
50+ years
Brief Summary
Major cardiovascular surgery is associated with postoperative cognitive decline (POCD), with a deterioration in memory, attention and speed of information processing. A multifactorial pathophysiology ...
Detailed Description
Systemic inflammation can activate the innate immune cells of the brain inducing neuroinflammation, which plays an important role in the pathogenesis of neurodegenerative disease. Major cardiovascular...
Eligibility Criteria
Inclusion
- Age \> 50 years
- Planned for on-pump coronary artery bypass grafting surgery
- High-affinity binder or mixed-affinity binders based on rs6971 polymorphism for TSPO
- Chronic use of statins (defined as pre-hospital use)
Exclusion
- Previous cardiac surgery.
- 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.
- Low-affinity binder based on rs6971 polymorphism for TSPO, or unable to determine rs6971 polymorphism.
- Patients with cognitive disorders that have not recovered enough to be able to understand the study leaflets and information for participation.
- 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).
- Auto-immune or auto-inflammatory disease
- Active infection \< 2 weeks prior to inclusion (defined as fever \>38.5 or antibiotic treatment)
- Kidney failure, defined by a MDRD-GFR\<15 ml/min/1.73m2
- Known contrast allergy for gadolinium
- 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.
Key Trial Info
Start Date :
February 18 2019
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
July 1 2022
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT04520802
Start Date
February 18 2019
End Date
July 1 2022
Last Update
March 31 2023
Active Locations (1)
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1
Department of Intensive Care Medicine, Radboud university medical center
Nijmegen, Netherlands, 6500HB