Clinical Trials Directory

Trials / Completed

CompletedNCT04520802

Neuroinflammation in Cognitive Decline Post-cardiac Surgery

Neuroinflammation in Cognitive Decline Post-cardiac Surgery: The FOCUS Study

Status
Completed
Phase
Study type
Observational
Enrollment
15 (actual)
Sponsor
Radboud University Medical Center · Academic / Other
Sex
All
Age
50 Years
Healthy volunteers

Summary

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.

Detailed description

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

Interventions

TypeNameDescription
DIAGNOSTIC_TEST18F-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

Timeline

Start date
2019-02-18
Primary completion
2022-07-01
Completion
2022-07-01
First posted
2020-08-20
Last updated
2023-03-31

Locations

1 site across 1 country: Netherlands

Source: ClinicalTrials.gov record NCT04520802. Inclusion in this directory is not an endorsement.