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

Phase 1

• Conditions: euroinflammation; Therapeutic area: Body processes [G] - Immune system processes [G12]

• Registration Number: EUCTR2016-002016-40-NL
• Lead Sponsor: Radboudumc

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-09-19
• Last Update Posted: 3 April 2017

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

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

-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: Interventional clinical trial of medicinal product
• Study Design: Not specified