Peri-interventional neuronal injury Blood–brain barrier disruption Impaired cerebral autoregulation Cerebral hypoxia / reduced cerebral oxygenation Cognitive dysfunction / neurocognitive impairment Stroke/TIA-associated neurological deficits I65.2 G45.19 I63.-
Conditions
Interventions
Group 1: Patients undergoing Carotid Endarterectomy (CEA)
• Potentially increased risk of microembolic events and subsequent neuronal injury.
• Pre- and postoperative cfDNA assessment in combination w
Sponsors
Universitätsmedizin Mmainz
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: • Age = 18 years • Written informed consent for study participation • Planned carotid endarterectomy (CEA) or carotid artery stenting (CAS) for high-grade asymptomatic internal carotid artery (ICA) stenosis of 70–90% according to NASCET criteria • No pre-existing neurological deficits (mRS > 2) • Ability to participate in follow-up assessments • Stenosis amenable to treatment with both CEA and CAS (no anatomical preference)
Exclusion criteria
Exclusion criteria: • Incomplete performance of the planned surgical intervention (e.g., aborted CEA or CAS procedure)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| • Determination of cfDNA concentrations in peripheral blood at predefined time points (pre-interventional, and 6, 24, and 48 hours post-intervention). • Comparison of cfDNA concentrations between the two intervention groups (CEA vs. CAS) to assess procedure-related cfDNA release. • Evaluation of temporal changes in cfDNA concentrations to characterize the dynamics of peri-interventional cfDNA release. | — |
Secondary
| Measure | Time frame |
|---|---|
| • Correlation of cfDNA concentrations with established biomarkers of neuronal injury (S100ß, NfL, GFAP). • Comparison of the temporal release kinetics of cfDNA and conventional neuronal biomarkers during the peri-interventional course. • Correlation of cfDNA concentrations with neurological outcome, assessed using the NIH Stroke Scale (NIHSS) at 24 hours post-intervention and the modified Rankin Scale (mRS) at 3 months. • Comparison of cfDNA release patterns, including cfDNA integrity index, between the two study groups (CEA vs. CAS). • Differences in neurological outcome measures (NIHSS, mRS, MoCA, and T-MoCA) between patients undergoing CEA and CAS. • Association between pre-interventional cfDNA concentrations and the degree of internal carotid artery stenosis. • Correlation of cfDNA concentrations with cerebral autoregulation assessed by near-infrared spectroscopy (NIRS) and arterial blood pressure monitoring (Mx = mean velocity index; TFA = transfer function analysis). • Correlation of cfDNA concentrations with regional cerebral oxygen saturation (crSpO2). • Investigation of the impact of intraoperative propofol sedation on cfDNA concentrations (subgroup analysis). • Identification of tissue-specific cfDNA fractions using methylation analyses, particularly for the detection of neuron-derived cfDNA in the context of potential intraoperative blood–brain barrier disruption. • Correlation between MRI-based morphological changes (e.g., microinfarctions, white matter alterations, perfusion deficits) and concentrations of cfDNA, NfL, GFAP, and S100ß. | — |
Countries
Germany
Contacts
Public ContactKatharina Hoeter
Universitätsmedizin Mainz
Outcome results
None listed