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

Radboudumc0 个研究点开始时间: 2016年9月19日最近更新: 2017年4月3日

试验速览

暂无简介。

•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

•-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.

发起方