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.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Tipo de estudo
Inscrição (Estimado)
Contactos e Locais
Contato de estudo
- Nome: Stergios Tzikas, Associate Professor of Cardiology
- Número de telefone: 002313312344
- E-mail: tzikas@auth.gr
Estude backup de contato
- Nome: Alexandros Evangeliou, Resident fo Cardiology
- Número de telefone: 00306977598469
- E-mail: apevange@auth.gr
Locais de estudo
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Thessaloniki, Grécia, 54642
- Recrutamento
- Third Department of Cardiology, Aristotle University of Thessaloniki, Greece
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Contato:
- Stergios Tzikas, Associate Professor of Cardiology
- Número de telefone: 002313312344
- E-mail: tzikas@auth.gr
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Contato:
- Alexandros Evangeliou, Resident of Cardiology
- Número de telefone: 00306977598469
- E-mail: apevange@auth.gr
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Subinvestigador:
- Vassilios Vassilikos
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Investigador principal:
- Stergios Tzikas
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Subinvestigador:
- Alexandros Evangeliou
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Subinvestigador:
- Christos Karkos
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Método de amostragem
População do estudo
Patients undergoing high-thromboembolic-risk transcatheter interventions (Carotid scenting and cardiac ablation procedure for cardiac arrhythmias.
Descrição
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
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Modelos de observação: CASE_CONTROL
- Perspectivas de Tempo: PROSPECTIVE
Coortes e Intervenções
Grupo / Coorte |
Intervenção / Tratamento |
|---|---|
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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. |
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Difference in serum neuron-specific enolase concentration between participants with and without new silent cerebral infarcts
Prazo: 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
Prazo: 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
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Correlation between serum neuron-specific enolase concentration and change in Montreal Cognitive Assessment score
Prazo: 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
Prazo: 24 hours before and 24 hours after the procedure.
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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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Colaboradores e Investigadores
Patrocinador
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
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Outros números de identificação do estudo
- 5141
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