euroinflammation in cognitive decline post-cardiac surgery: The FOCUS study

Completed

• Conditions: postoperative cerebral dysfunction; postoperative cognitive dysfunction (POCD); 10014623; 10007593

• Registration Number: NL-OMON42968
• Lead Sponsor: Radboud Universitair Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 40

Inclusion Criteria

Planned for coronary artery bypass grafting surgery (CABG)
Age > 50 years
High-affinity or mixed affinity binders based on rs6971 polymorphism for TSPO

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.

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Differences in PET tracer uptake before and after CABG. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Neuropsychological outcomes. </p><br>