Using single-cell transcriptomic and epigenetic profiles of (immune) cells in liquor to investigate which biological and cellular processes are involved in (accelerated) brain aging and cognitive decline after systemic inflammation.
ID
Source
Brief title
Condition
- Encephalopathies
- Vascular therapeutic procedures
- Aneurysms and artery dissections
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary endpoint are biological pathways and markers based on transcriptomic
and epigenetic data, with patients divided into two groups based on cognitive
assessment after 6 months.
Secondary outcome
Primary endpoint are biological pathways and markers based on transcriptomic
and epigenetic data, with patients divided into two groups based on cognitive
assessment after 12 months.
Background summary
Systemic inflammation activates immune cells in the brain and causes
neuroinflammation, which is believed to play a key role in the development of
cognitive decline due to post-systemic inflammation. Major cardiovascular
surgery causes a severe systemic inflammatory response. Systemic
inflammation-induced neuroinflammation is believed to be a major cause of
postoperative cognitive decline (POCD) in patients who have undergone major
surgery, such as thoracic aortic aneurysm (TAA) repair surgery.
Study objective
Using single-cell transcriptomic and epigenetic profiles of (immune) cells in
liquor to investigate which biological and cellular processes are involved in
(accelerated) brain aging and cognitive decline after systemic inflammation.
Study design
Time series design observational study.
Study burden and risks
- Blood and cerebrospinal fluid sampling occurs through intravascular catheters
and the external lumbar drain that are already present due to the standard of
care related to the surgery. Therefore, this does not add an additional burden.
- Patients will undergo three brain MRIs (pre-, within 2 weeks post-surgery
during their hospitalization once they are sufficiently restored from the
surgery, and at 6 months visit to outpatient clinic). The MRI bears some burden
but with a low to negligible risk.
- Patient will undergo a total of 4 neuropsychological assessments. These will
be either during the hospital stay (first two), during their clinical routine
visit to the outpatient clinic at the hospital (6 months) and at their own
house (12 months). These bear little burden and a low to negligible risk.
Geert Grooteplein-Zuid 10
Nijmegen 6525GA
NL
Geert Grooteplein-Zuid 10
Nijmegen 6525GA
NL
Listed location countries
Age
Inclusion criteria
Planned for elective thoraco-abdominal aortic aneurysm repair that also have an
ELD as part of their routine clinical care at Radboudumc
Exclusion criteria
- Disease states associated with a state of neuroinflammation: brain or spinal
surgery within the last 6 months, meningitis or brain infection within the last
6 months, presence of a CSF catheter or shunt, presence of known brain tumor,
brain injury (e.g., stroke, or subarachnoid hemorrhage) within the last 12
months, moderate-severe brain trauma in previous medical history, chronic
active alcoholism or substance use.
- Pre-existing dementia or neurodegenerative disease
- Cognitive impairment interfering with the ability to understand informational
study material.
- Chronic (>2 weeks) use of immunosuppressive agents (see table 3.3.A, below)
- Concomitant diseases resulting in severe immunosuppression (e.g., HIV,
hematological malignancies)
- Patients that do not speak Dutch or analphabetic patients.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL86164.091.24 |