Neuroinflammation in Cognitive Decline Post-cardiac Surgery

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

15 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-02-18

Study Completion Date

2022-07-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Major cardiovascular surgery is associated with postoperative cognitive decline (POCD), with a deterioration in memory, attention and speed of information processing. A multifactorial pathophysiology is presumed but this study focuses on the role of (neuro)inflammation in the development of POCD after coronary artery bypass grafting (CABG) surgery.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Brain-heart Interaction in Coronary Plaque Stability and Cardiovascular Events

NCT05545618

Coronary Artery Disease

UNKNOWN

Risk of Developing Dementia and Associated Factors in Patients With Normal Brain FDG PET

NCT04804722

Neurodegenerative Diseases Cognitive Disorder

COMPLETED

Determinants of Cognitive Impairment After Acute Coronary Syndrome

NCT00982176

Coronary Syndrome

COMPLETED

Functional Magnetic Resonance Imaging (fMRI) of Brain in ICU Survivors With Cognitive Impairment

NCT03946839

Cognitive Impairment Functional Magnetic Resonance Imaging Septic Shock +1 more

COMPLETED

MECHANISMS OF NEURONAL RESILIENCE IN ALZHEIMER'S DISEASE AND ITS FOCAL VARIANTS: A PET/MR STUDY

NCT04150198

Alzheimer Disease, Early Onset Posterior Cortical Atrophy

RECRUITING NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Systemic inflammation can activate the innate immune cells of the brain inducing neuroinflammation, which plays an important role in the pathogenesis of neurodegenerative disease. Major cardiovascular surgery induces a severe systemic inflammatory response.There is growing support that neuroinflammation is a pivotal factor in the development of postoperative cognitive decline (POCD) due to surgery-related systemic inflammation.

Although the neuroinflammatory hypothesis is scientifically accepted, in vivo human data supporting the role of neuroinflammation in severe systemic inflammation such as major surgery are still lacking. In the last decades, several nuclear imaging tracers have been developed that can quantitatively measure microglial and astrocytic activation in vivo, by targeting the mitochondrial 18kDa translocator protein (TSPO).

The investigators hypothesize that cardiac surgery induces a neuroinflammatory response and that its presence is related to acute and long term brain dysfunction postoperatively. This will be studied by pre- and postoperative PET brain imaging using a 18F-DPA-714 tracer targeting TSPO, combined with longitudinal neuropsychological examinations. Structural changes in the brain will be recorded on MRI prior to and after cardiac surgery to enable us to correct for the potentially confounding effects of neurovascular events on cognitive outcomes after CABG surgery.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Postoperative Cognitive Dysfunction Coronary Artery Disease Pathophysiology

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

POCD

Patients with postoperative cognitive decline (POCD) after coronary artery bypass grafting (CABG) surgery

18F-DPA-714 PET/CT neuroimaging

Intervention Type DIAGNOSTIC_TEST

* Pre- and postoperative neuroimaging using 18F-DPA-714 PET/CT and brain MRI.
* Longitudinal neuropsychological examinations (up to 6 months postoperatively)
* Blood samples are drawn to assess the severity of the systemic inflammatory response

no POCD

Patients without postoperative cognitive decline (POCD) after coronary artery bypass grafting (CABG) surgery

18F-DPA-714 PET/CT neuroimaging

Intervention Type DIAGNOSTIC_TEST

* Pre- and postoperative neuroimaging using 18F-DPA-714 PET/CT and brain MRI.
* Longitudinal neuropsychological examinations (up to 6 months postoperatively)
* Blood samples are drawn to assess the severity of the systemic inflammatory response

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

18F-DPA-714 PET/CT neuroimaging

* Pre- and postoperative neuroimaging using 18F-DPA-714 PET/CT and brain MRI.
* Longitudinal neuropsychological examinations (up to 6 months postoperatively)
* Blood samples are drawn to assess the severity of the systemic inflammatory response

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No