Clinical trial Recruiting at 1 site Observational Ages 18 and up

Biomarkers That Signal Silent Strokes in High-Risk Cardiac Procedures

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

Run by Aristotle University Of Thessaloniki · NCT07844850 · Data updated 2026-11-12

This study tests whether blood biomarkers NSE and NFLs can predict silent brain injuries and later cognitive problems in adults having high-risk transcatheter heart procedures.

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Quick facts

Study typeObservational
Ages18 Years and up
SexAll
Enrollment100 (estimated)
SponsorAristotle University Of Thessaloniki
Academic / other
Locations1 site (Thessaloniki)
StatusRecruiting
StartedJune 10, 2025
Main results expectedMay 1, 2027
Study endsJuly 1, 2027
Registry record updatedSeptember 28, 2026
Trial IDNCT07844850 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Adults over 18 undergoing high-thromboembolic-risk transcatheter interventions who consent to monitoring and blood biomarker testing.

Probably not a fit

Patients who do not develop biomarker elevations or silent brain injuries, or those with other confounding conditions, may not see a direct benefit.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study follows adults undergoing transcatheter interventions with high thromboembolic risk to see if levels of neuron specific enolase (NSE) and neurofilaments (NFLs) in blood can forecast the occurrence of silent cerebral infarctions detected by imaging and subsequent cognitive decline. It does not involve an intervention beyond standard care plus biomarker measurement. Researchers will correlate biomarker data with imaging findings and long-term cognitive outcomes to identify prognostic value. The study is conducted at the Third Department of Cardiology, Aristotle University of Thessaloniki, with independent consent and monitoring requirements. Results could help stratify risk and inform post-procedure monitoring strategies.

Why it matters

Potential benefit: If successful, the biomarkers could help doctors identify patients at higher risk for silent brain injury and cognitive issues after high-risk procedures, enabling closer follow-up and tailored care.

How similar studies have gone: Prior research has shown some links between biomarkers and brain injury in various settings, but the specific prognostic role of NSE and NFLs for silent strokes after these interventions is novel or exploratory.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

1. Age \> 18 years
2. Signed consent
3. Agreement on monitoring required by the study

Exclusion Criteria:

1. Age \< 18 years
2. Patients with known malignancies
3. Patients who are unable or unwilling to give consent

Where it's running

  • Third Department of Cardiology, Aristotle University of Thessaloniki, Greece
    Thessaloniki, Greece
    Recruiting

Study contacts

Similar studies

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.