E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
|
E.1.1.1 | Medical condition in easily understood language |
inflammation in the brain |
|
E.1.1.2 | Therapeutic area | Body processes [G] - Immune system processes [G12] |
MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
Measure in vivo neuroinflammation before and after coronary artery bypass grafting surgery (CABG) |
|
E.2.2 | Secondary objectives of the trial |
Relationship of in vivo neuroinflammation and neurocognitive outcomes after CABG surgery. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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 |
|
E.4 | Principal 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.
|
|
E.5 End points |
E.5.1 | Primary end point(s) |
Difference in PET tracer uptake before and after cardiac surgery |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
1-2 weeks after CABG surgery |
|
E.5.2 | Secondary end point(s) |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
pre-surgery, at discharge from the hospital, after 6 weeks and after 6 months |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | Yes |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | No |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Yes |
E.6.13.1 | Other scope of the trial description |
|
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | Yes |
E.8.1.7.1 | Other trial design description |
observational time series design |
|
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | |