Biomarkers as Prognostic Factors of Silent, Cerebral Infarctions in Patients Undergoing High-thromboembolic-risk Transcatheter Interventions

NCT07844850 | Recruiting

• 1 other identifier: 5141
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Background: The transcatheter interventions with high thromboembolic risk, as transcatheter carotid angioplasty or transcatheter ablation of cardiac arrhythmias are associated with asymptomatic strokes- silent strokes. The silent strokes are cerebral infarctions with small diameter which are diagnosed with computed tomography or magnetic resonance imaging (MRI). Silent cerebral infarctions (SCIs) are associated with neurological deficits, cognitive impairment, high mortality and high risk of dementia. There are biomarkers, as neuron specific enolase (NSE) and neurofilaments (NFLs) which are indicated for the prognosis of these patients. Aim: The aim of this study is the prognostic role of biomarkers NSE and NFLs in patients undergoing high-thromboembolic-risk transcatheter interventions. This study will assess the hypothesis that the level of these biomarkers could predict the development of SCIs and the long-term cognitive impairment. Study type - materials: This study is a prospective, observational study. Patients undergoing highthromboembolic-risk transcatheter interventions will be included in this study. Protocol: All the demographic and clinical characteristics of patients will be recorded. Blood samples will be obtained, 24 hours pre-interventionally and 24 hours post-interventionally. The blood samples will be centrifugated and will be freezed at -80 οC for the measurement of biomarkers. MRI will be conducted 24 hours pre- and postinterventionally. The neurological assessment will be conducted with the use of Mini Mental State Examination (MMSE) and the Montreal Cognitive Assessment (MoCA) questionnaires, 24 hours pre-interventionally, 24 hours and 6 months postinterventionally. Outcomes: The primary outcome is the association between level of biomarkers and the development of SCIs in MRI post-procedurally. Secondary outcomes concern the probable association of biomarkers with the cognitive impairment. The data will be assessed with statistical analysis and will be interpreted. The results of this study will be published with the view to create algorithms and prognostic tools for appropriate management of these patients.

Conditions

Silent Cerebral Infarct; Biomarkers / Blood; Cardiac Ablation; Cognitive Impairment

Outcome Measures

Primary Outcomes (2)

• Difference in serum neuron-specific enolase concentration between participants with and without new silent cerebral infarcts

  In participants undergoing carotid artery stenting, serum neuron-specific enolase (NSE) concentration at 24 hours after the procedure will be compared between participants with and without new silent cerebral infarcts. NSE will be measured using an enzyme-linked immunosorbent assay (ELISA). Concentrations and the between-group difference will be expressed in ng/mL.

  Blood sampling and brain MRI at 24 hours before and 24 hours after the procedure; comparison based on the 24-hour post-procedural NSE concentration.

• Difference in serum neurofilament light chain concentration between participants with and without new silent cerebral infarcts

  In participants undergoing carotid artery stenting, serum neurofilament light chain (NfL) concentration at 24 hours after the procedure will be compared between participants with and without new silent cerebral infarcts. NfL will be measured using a dot blot assay. Concentrations and the between-group difference will be expressed in μg/mL. New silent cerebral infarcts are defined as new ischemic lesions on post-procedural diffusion-weighted brain MRI that were absent on baseline MRI, without corresponding new clinical neurological symptoms.

  Blood sampling and brain MRI at 24 hours before and 24 hours after the procedure; comparison based on the 24-hour post-procedural NfL concentration

Secondary Outcomes (2)

• Correlation between serum neuron-specific enolase concentration and change in Montreal Cognitive Assessment score

  24 hours before and 24 hours after the procedure.

• Correlation between serum neurofilament light chain concentration and change in Montreal Cognitive Assessment score

  24 hours before and 24 hours after the procedure.

Study Arms (2)

Patients with new silent strokes at post-procedural MRI

Procedure: High-thromboembolic-risk transcatheter interventions

Patients without new silent strokes at post-procedural MRI

Procedure: High-thromboembolic-risk transcatheter interventions

Interventions

High-thromboembolic-risk transcatheter interventions PROCEDURE

Patients diagnosed with carotid artery disease who will undergo transcatheter revascularization surgery and patients with cardiac arrhythmias who will undergo transcatheter ablation procedure will be enrolled.

Patients with new silent strokes at post-procedural MRI; Patients without new silent strokes at post-procedural MRI

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing high-thromboembolic-risk transcatheter interventions (Carotid scenting and cardiac ablation procedure for cardiac arrhythmias.

You may qualify if:

• Age \> 18 years
• Signed consent
• Agreement on monitoring required by the study

You may not qualify if:

• Age \< 18 years
• Patients with known malignancies
• Patients who are unable or unwilling to give consent

Sponsors & Collaborators

• Aristotle University Of Thessaloniki: lead

Study Sites (1)

Third Department of Cardiology, Aristotle University of Thessaloniki, Greece

Thessaloniki, 54642, Greece

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood plasma

MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Central Study Contacts

Stergios Tzikas, Associate Professor of Cardiology

CONTACT

002313312344; tzikas@auth.gr

Alexandros Evangeliou, Resident fo Cardiology

CONTACT

00306977598469; apevange@auth.gr

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Cardiology

Study Record Dates

• First Submitted: December 5, 2025
• First Posted: September 28, 2026
• Study Start: June 10, 2025
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: September 28, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

GR (1)