Biomarkers as Prognostic Factors of Silent, Cerebral Infarctions in Patients Undergoing High-thromboembolic-risk Transcatheter Interventions
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Difference in serum neuron-specific enolase concentration between participants with and without new silent cerebral infarcts
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age > 18 years
- •Signed consent
- •Agreement on monitoring required by the study
排除标准
- •Age < 18 years
- •Patients with known malignancies
- •Patients who are unable or unwilling to give consent
研究组 & 干预措施
Patients with new silent strokes at post-procedural MRI
干预措施: High-thromboembolic-risk transcatheter interventions (Procedure)
Patients without new silent strokes at post-procedural MRI
干预措施: High-thromboembolic-risk transcatheter interventions (Procedure)
结局指标
主要结局
Difference in serum neuron-specific enolase concentration between participants with and without new silent cerebral infarcts
时间窗: 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
时间窗: 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.
次要结局
- 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.)
研究者
Stergios Tzikas
Associate Professor of Cardiology
Aristotle University Of Thessaloniki