Neuroinflammation in Cognitive Decline Post-cardiac Surgery
FOCUS
3 other identifiers
observational
15
1 country
1
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 is presumed but this study focuses on the role of (neuro)inflammation in the development of POCD after coronary artery bypass grafting (CABG) surgery.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Feb 2019
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 18, 2019
CompletedFirst Submitted
Initial submission to the registry
July 3, 2020
CompletedFirst Posted
Study publicly available on registry
August 20, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2022
CompletedMarch 31, 2023
March 1, 2023
3.4 years
July 3, 2020
March 28, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Change in TSPO PET tracer uptake at 3-7 days post-surgery
18F-DPA-714
3-7 days post-surgery minus preoperative (= day before surgery)
Secondary Outcomes (9)
Occurrence of postoperative cognitive dysfunction (POCD)
Baseline (preoperative), postoperative (3-7 days after surgery, 6 weeks and 6 months)
Whole brain TSPO PET tracer uptake pre- and 3-7 days post-surgery
pre- and 3-7 days post-surgery
Pro- and anti-inflammatory in vivo cytokine concentrations [in pg/ml]
Day before surgery, during surgery (stop extracorporeal circulation (ECC)), after surgery (6 hours after stop ECC, 24 hours after incision, 3-7 days post-surgery and 6 weeks after surgery)
Ex vivo cytokine production of stimulated monocytes [in ng/10^9 monocytes]
Day before surgery, 3-7 days and 6 weeks after surgery
Flowcytometry analysis to study the inflammatory phenotype of the cells
Day before surgery, 3-7 days and 6 weeks after surgery
- +4 more secondary outcomes
Study Arms (2)
POCD
Patients with postoperative cognitive decline (POCD) after coronary artery bypass grafting (CABG) surgery
no POCD
Patients without postoperative cognitive decline (POCD) after coronary artery bypass grafting (CABG) surgery
Interventions
* Pre- and postoperative neuroimaging using 18F-DPA-714 PET/CT and brain MRI. * Longitudinal neuropsychological examinations (up to 6 months postoperatively) * Blood samples are drawn to assess the severity of the systemic inflammatory response
Eligibility Criteria
Patients \>50 years that are planned to undergo elective coronary artery bypass grafting (CABG) surgery by the cardiothoracic surgery department of the Radboud university medical center in Nijmegen (NL).
You may qualify if:
- 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)
You may not qualify if:
- 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
- +6 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Intensive Care Medicine, Radboud university medical center
Nijmegen, 6500HB, Netherlands
Related Publications (1)
Peters van Ton AM, Duindam HB, van Tuijl J, Li WW, Dieker HJ, Riksen NP, Meijer FA, Kessels RP, Kohn N, van der Hoeven JG, Pickkers P, Rijpkema M, Abdo WF. Neuroinflammation in cognitive decline post-cardiac surgery (the FOCUS study): an observational study protocol. BMJ Open. 2021 May 11;11(5):e044062. doi: 10.1136/bmjopen-2020-044062.
PMID: 33980522BACKGROUND
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Wilson F Abdo, MD PhD
Radboud University Medical Center
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
July 3, 2020
First Posted
August 20, 2020
Study Start
February 18, 2019
Primary Completion
July 1, 2022
Study Completion
July 1, 2022
Last Updated
March 31, 2023
Record last verified: 2023-03