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临床试验/NCT02910180
NCT02910180招募中不适用

Genetic, Metabolic, and Growth Factor Repository for Cerebrovascular Disorders

Cedars-Sinai Medical Center1 个研究点 分布在 1 个国家目标入组 900 人开始时间: 2016年9月最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
900
试验地点
1
主要终点
Change in modified Rankin Scale (mRS) score

研究概览

简要总结

This study encompasses the maintenance and utilization of a repository of samples from patients with cerebrovascular disease and stroke. The types of tissue taken are blood, cerebrospinal fluid (CSF), tissue, and microdialysis samples. Future analysis of these samples can potentially help investigators to better categorize groups of patients, understand the underlying etiology of these pathologies, identify markers that are associated with favorable or poor outcomes, and track changes that occur during the natural course of the disease or with treatment. This is a prospective observational study which will use samples from such patients to create this library which can be used to explore these questions in the future.

详细描述

Genetic and metabolic profiling has become an important means to evaluate various pathologies, their effects on patients, and their treatments. In regards to cerebrovascular disease and stroke, there are a number of hypotheses which have been proposed. The levels and types of various angiogenic factors in the blood and tissues have been proposed to be predictive of patient outcome after ischemic stroke and treatment for stroke. Likewise, genetic factors may predict outcome or response to various types of treatments.

The role of biological samples in furthering our understandings about cerebrovascular disease and treatment are well documented. Muscle microdialysis samples have confirmed the presence of sublethal ischemia during the induction of remote ischemic preconditioning. The effects of remote ischemic preconditioning on the coagulation profile, DNA methylation, and cell cycle gene expression of patients with aneurysmal subarachnoid hemorrhage have also been elucidated. Blood samples collected in patients with intracranial arterial stenosis have produced many insights. Inflammatory cell profiles in patient who receive encephaloduroarteriosynangiosis (EDAS) surgery have been characterized. Angiogenic factor measurements have been shown to predict the degree of neovascularization in patients post-EDAS. In patients with intracranial atherosclerosis, angiogenic factor profiles were found to strongly correlate with failure of medical management and poor outcomes.

It is clear that genetic and metabolic profiling are effective tools in evaluating the effects of cerebrovascular disease and their treatments. This study encompasses the maintenance and utilization of a repository of samples from patients with cerebrovascular disease and stroke. For every patient enrolled in the study, relevant patient information such as age, gender, diagnosis, medical history, family history, procedures/treatments received, radiological reports, and patient outcomes are recorded. This information is updated upon every follow-up during the study. The types of tissue taken are blood, cerebrospinal fluid (CSF), tissue, and microdialysis samples.

Future analysis of these samples can potentially help investigators to better categorize groups of patients, understand the underlying etiology of these pathologies, identify markers that are associated with favorable or poor outcomes, and track changes that occur during the natural course of the disease or with treatment. This repository serves as the groundwork to explore these questions in the future.

研究设计

研究类型
Observational
观察模型
Other
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

入选标准

  • All patients diagnosed with cerebral vascular disease, regardless of gender, age, ethnicity/race, stage of disease or treatment, are eligible.
  • Expected availability of clinical follow up data
  • Participants must be willing to provide written, informed consent obtained in accordance with institutional and federal guidelines.

排除标准

  • Pregnant women are excluded from the study.

结局指标

主要结局

Change in modified Rankin Scale (mRS) score

时间窗: Baseline, 1 Month, 3 Months, and 6 Months

Change in NIH Stroke Scale score

时间窗: Baseline, 1 Month, 3 Months, and 6 Months

Change in Barthel Index

时间窗: Baseline, 1 Month, 3 Months, and 6 Months

Change in Montreal Cognitive Assessment test score

时间窗: Baseline, 1 Month, 3 Months, and 6 Months

次要结局

  • Change in Angiographic Neovascularization(Baseline and 6 Months)
  • Change in Angiogenic Factor Measurements(Baseline, 1 Month, 3 Months, 6 Months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Nestor R. Gonzalez, MD, MSCR.

Professor of Neurosurgery

Cedars-Sinai Medical Center

研究点 (1)

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