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Neuroinflammation in cognitive decline post-cardiac surgery: the FOCUS study

Neuroinflammation in cognitive decline post-cardiac surgery: the FOCUS study - The FOCUS study

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2016-002016-40-NL
Enrollment
40
Registered
2016-09-19
Start date
2017-03-01
Completion date
Unknown
Last updated
2024-12-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neuroinflammation

Interventions

Sponsors

Radboudumc
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Patients planned for coronary artery bypass grafting surgery (CABG) Age > 50 years High-affinity binders or mixed-affinity binders based on rs6971 polymorphism for TSPO Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 10 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 30

Exclusion criteria

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 outcomes

Primary

MeasureTime frame
Main Objective: Measure in vivo neuroinflammation before and after coronary artery bypass grafting surgery (CABG);Secondary Objective: Relationship of in vivo neuroinflammation and neurocognitive outcomes after CABG surgery. ;Primary end point(s): Difference in PET tracer uptake before and after cardiac surgery;Timepoint(s) of evaluation of this end point: 1-2 weeks after CABG surgery

Secondary

MeasureTime frame
Secondary end point(s): Neurocognitive outcomes;Timepoint(s) of evaluation of this end point: pre-surgery, at discharge from the hospital, after 6 weeks and after 6 months

Countries

Netherlands

Contacts

Public ContactDepartment of Intensive Care

Radboudumc

nienke.petersvanton@radboudumc.nl

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026