Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:47 AM
Ignite Modification Date:
2025-12-25 @ 3:47 AM
NCT ID:
NCT04520802
Eligibility Criteria:
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.
Sex:
ALL
Minimum Age:
50 Years
Study:
NCT04520802
Study Brief:
Protocol Section:
NCT04520802