Coronary Artery Disease Clinical Trial
— FOCUSOfficial title:
Neuroinflammation in Cognitive Decline Post-cardiac Surgery: The FOCUS Study
Verified date | March 2023 |
Source | Radboud University Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 15 |
Est. completion date | July 1, 2022 |
Est. primary completion date | July 1, 2022 |
Accepts healthy volunteers | |
Gender | All |
Age group | 50 Years and older |
Eligibility | 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 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 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. |
Country | Name | City | State |
---|---|---|---|
Netherlands | Department of Intensive Care Medicine, Radboud university medical center | Nijmegen |
Lead Sponsor | Collaborator |
---|---|
Radboud University Medical Center |
Netherlands,
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Occurrence of postoperative cognitive dysfunction (POCD) | POCD diagnosis based on neuropsychological assessments including TMT A&B, Stroop I, II, III, WAIS-IV - digit span, LDST, RAVLT, RCFT, RBMT-3 face recognition, LFT and token test. POCD diagnosis is made when patients are newly impaired in one or more cognitive domains (memory, executive functioning, speed of processing and language), or when the average test rating has declined in more than one domain compared to baseline. | Baseline (preoperative), postoperative (3-7 days after surgery, 6 weeks and 6 months) | |
Secondary | Whole brain TSPO PET tracer uptake pre- and 3-7 days post-surgery | 18F-DPA-714 | pre- and 3-7 days post-surgery | |
Secondary | Pro- and anti-inflammatory in vivo cytokine concentrations [in pg/ml] | TNFa, IL6, IL-1B, IL10, IL-1RA | 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) | |
Secondary | Ex vivo cytokine production of stimulated monocytes [in ng/10^9 monocytes] | TNFa, IL6, IL1B, MCP1, IL10 | Day before surgery, 3-7 days and 6 weeks after surgery | |
Secondary | Flowcytometry analysis to study the inflammatory phenotype of the cells | HLA-DR, CCR2, CD11b, CD14, CD16 | Day before surgery, 3-7 days and 6 weeks after surgery | |
Secondary | Complete blood count | including leukocyte differentiation measured on an automated hematology analyzer | 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) | |
Secondary | Ex vivo cytokine production of healthy donor monocytes, after exposure to patient serum obtained during CABG surgery | Healthy donor monocytes will be exposed to patient serum obtained during surgery, to see whether this changes the ex vivo cytokine producing capacity (TNFa, IL6, IL10) | Perioperatively at stop extracorporeal circulation (ECC) | |
Secondary | Number of newly developed (ischemic and hemorrhagic) brain and vascular wall lesions | pre- and 3-7 days post-surgery | ||
Secondary | Delta brain activity in three large scale brain networks involved in stress reactivity on resting-state fMRI | pre- and 3-7 days post-surgery |
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