Last updated: March 28, 2023
Sponsor: Radboud University Medical Center
Overall Status: Completed
Phase
N/A
Condition
Atherosclerosis
Thrombosis
Memory Problems
Treatment
N/AClinical Study ID
NCT04520802
NL.57785.091.16
CMO 2016-2598
2016-002016-40
Ages > 50 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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 determiners6971 polymorphism.
- Patients with cognitive disorders that have not recovered enough to be able tounderstand 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 interferingwith 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 thelast 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 antibiotictreatment)
- 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 deliriumdiagnosis.
- Analphabetic patients.
- No written informed consent obtained.
Study Design
Total Participants: 15
Study Start date:
February 18, 2019
Estimated Completion Date:
July 01, 2022
Study Description
Connect with a study center
Department of Intensive Care Medicine, Radboud university medical center
Nijmegen, 6500HB
NetherlandsSite Not Available

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