Biomarkers as Prognostic Factors of Silent, Cerebral Infarctions in Patients Undergoing High-thromboembolic-risk Transcatheter Interventions (PRINCESS)
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.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Type d'étude
Inscription (Estimé)
Contacts et emplacements
Coordonnées de l'étude
- Nom: Stergios Tzikas, Associate Professor of Cardiology
- Numéro de téléphone: 002313312344
- E-mail: tzikas@auth.gr
Sauvegarde des contacts de l'étude
- Nom: Alexandros Evangeliou, Resident fo Cardiology
- Numéro de téléphone: 00306977598469
- E-mail: apevange@auth.gr
Lieux d'étude
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Thessaloniki, Grèce, 54642
- Recrutement
- Third Department of Cardiology, Aristotle University of Thessaloniki, Greece
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Contact:
- Stergios Tzikas, Associate Professor of Cardiology
- Numéro de téléphone: 002313312344
- E-mail: tzikas@auth.gr
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Contact:
- Alexandros Evangeliou, Resident of Cardiology
- Numéro de téléphone: 00306977598469
- E-mail: apevange@auth.gr
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Sous-enquêteur:
- Vassilios Vassilikos
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Chercheur principal:
- Stergios Tzikas
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Sous-enquêteur:
- Alexandros Evangeliou
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Sous-enquêteur:
- Christos Karkos
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
Méthode d'échantillonnage
Population étudiée
Patients undergoing high-thromboembolic-risk transcatheter interventions (Carotid scenting and cardiac ablation procedure for cardiac arrhythmias.
La description
Inclusion Criteria:
- Age > 18 years
- Signed consent
- Agreement on monitoring required by the study
Exclusion Criteria:
- Age < 18 years
- Patients with known malignancies
- Patients who are unable or unwilling to give consent
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Modèles d'observation: CASE_CONTROL
- Perspectives temporelles: PROSPECTIVE
Cohortes et interventions
Groupe / Cohorte |
Intervention / Traitement |
|---|---|
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Patients with new silent strokes at post-procedural MRI
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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. |
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Patients without new silent strokes at post-procedural MRI
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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. |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Difference in serum neuron-specific enolase concentration between participants with and without new silent cerebral infarcts
Délai: 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.
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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.
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Difference in serum neurofilament light chain concentration between participants with and without new silent cerebral infarcts
Délai: 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
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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
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Correlation between serum neuron-specific enolase concentration and change in Montreal Cognitive Assessment score
Délai: 24 hours before and 24 hours after the procedure.
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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 |
24 hours before and 24 hours after the procedure.
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Correlation between serum neurofilament light chain concentration and change in Montreal Cognitive Assessment score
Délai: 24 hours before and 24 hours after the procedure.
|
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. |
24 hours before and 24 hours after the procedure.
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Collaborateurs et enquêteurs
Parrainer
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 5141
Plan pour les données individuelles des participants (IPD)
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Informations sur les médicaments et les dispositifs, documents d'étude
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