Silent Cerebral InfarctPRINCESSNCT07844850
Biomarkers as Prognostic Factors of Silent, Cerebral Infarctions in Patients Undergoing High-thromboembolic-risk Transcatheter Interventions
An observational study of Silent Cerebral Infarct and Biomarkers / Blood, run by Aristotle University Of Thessaloniki at 1 site in Greece.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Silent Cerebral Infarct, Biomarkers / Blood, Cardiac Ablation
- What is being tested?
- High-thromboembolic-risk transcatheter interventions
- Type of treatment
- Surgery or procedure
- How many people
- 100 participants
- Where
- 1 siteGreece
- Study dates
- 10 Jun 2025to 1 Jul 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients undergoing high-thromboembolic-risk transcatheter interventions (Carotid scenting and cardiac ablation procedure for cardiac arrhythmias.
Who may be able to join
- Age > 18 years
- Signed consent
- Agreement on monitoring required by the study
Who cannot join
- Age < 18 years
- Patients with known malignancies
- Patients who are unable or unwilling to give consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Greece1 site, 1 recruiting
- Recruiting
Third Department of Cardiology, Aristotle University of Thessaloniki, Greece
Thessaloniki, 54642
Stergios Tzikas, Associate Professor of Cardiology, 002313312344, tzikas@auth.gr
Alexandros Evangeliou, Resident of Cardiology, 00306977598469, apevange@auth.gr
About this study
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.
Read more
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.
- Being tested
- High-thromboembolic-risk transcatheter interventions
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High-thromboembolic-risk transcatheter interventionsProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Patients with new silent strokes at post-procedural MRI | Not described Receives: Procedure: High-thromboembolic-risk transcatheter interventions | |
| Patients without new silent strokes at post-procedural MRI | Not described Receives: Procedure: High-thromboembolic-risk transcatheter interventions |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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
The correlation between serum neuron-specific enolase (NSE) concentration at 24 hours after the procedure and the change in Montreal Cognitive Assessment (MoCA) total score will be assessed using Spearman's rank correlation coefficient.
NSE will be measured using an enzyme-linked immunosorbent assay (ELISA) and expressed in ng/mL.
MoCA total scores range from 0 to 30 points, with higher scores indicating better cognitive performance. Change will be calculated as the 24-hour post-procedural score minus the pre-procedural score; negative values indicate deterioration
Measured: 24 hours before and 24 hours after the procedure.
Correlation between serum neurofilament light chain concentration and change in Montreal Cognitive Assessment score
The correlation between serum neurofilament light chain (NfL) concentration at 24 hours after the procedure and the change in Montreal Cognitive Assessment (MoCA) total score will be assessed using Spearman's rank correlation coefficient.
NfL will be measured using a dot blot assay and expressed in μg/mL.
MoCA total scores range from 0 to 30 points, with higher scores indicating better cognitive performance. Change will be calculated as the 24-hour post-procedural score minus the pre-procedural score; negative values indicate deterioration.
Measured: 24 hours before and 24 hours after the procedure.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2026
- Study start10 Jun 2025
- Primary completion1 May 2027 (estimated)
- Study completion1 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Silent Cerebral InfarctStudies of the same condition, open and under way.
- More trials run by Aristotle University Of ThessalonikiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aristotle University Of Thessaloniki
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stergios Tzikas, Aristotle University Of Thessaloniki
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07844850
- Sponsor's protocol ID
- 5141
- Acronym
- PRINCESS
- Status last verified
- Sep 2026
- First submitted
- 5 Dec 2025
- Last updated
- 28 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biomarkers as Prognostic Factors of Silent, Cerebral Infarctions in Patients Undergoing High-thromboembolic-risk Transcatheter Interventions
- ClinicalTrials.gov ID
- NCT07844850
- Acronym / sponsor ID
- PRINCESS / 5141
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Aristotle University Of ThessalonikiUniversity, hospital or other
- Study start
- 10 Jun 2025 (actual)
- Primary completion
- 1 May 2027 (estimated)
- Study completion
- 1 Jul 2027 (estimated)
- First posted
- 28 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing high-thromboembolic-risk transcatheter interventions (Carotid scenting and cardiac ablation procedure for cardiac arrhythmias.
Key inclusion criteria (3 listed)
- Age > 18 years
- Signed consent
- Agreement on monitoring required by the study
Key exclusion criteria (3 listed)
- Age < 18 years
- Patients with known malignancies
- Patients who are unable or unwilling to give consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High-thromboembolic-risk transcatheter interventionsPatients 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. | Procedure or surgery | Patients with new silent strokes at post-procedural MRI, Patients without new silent strokes at post-procedural MRI |
Primary outcome
Difference in serum neuron-specific enolase concentration between participants with and without new silent cerebral infarcts
Time frame: 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.
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.
Difference in serum neurofilament light chain concentration between participants with and without new silent cerebral infarcts
Time frame: 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
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.
2 secondary outcomes
Correlation between serum neuron-specific enolase concentration and change in Montreal Cognitive Assessment score
Time frame: 24 hours before and 24 hours after the procedure.
Correlation between serum neurofilament light chain concentration and change in Montreal Cognitive Assessment score
Time frame: 24 hours before and 24 hours after the procedure.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Silent Cerebral Infarct and Biomarkers / Blood, run by Aristotle University Of Thessaloniki at 1 site in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Stergios Tzikas, Associate Professor of Cardiology (002313312344, tzikas@auth.gr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in serum neuron-specific enolase concentration between participants with and without new silent cerebral infarcts (time frame: 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.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2026.