Genetic, Metabolic, and Growth Factor Repository for Cerebrovascular Disorders
- Conditions
- Cerebrovascular DiseasesRepositoryIschemic Stroke
- Registration Number
- NCT02910180
- Lead Sponsor
- Cedars-Sinai Medical Center
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 900
- 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.
- Pregnant women are excluded from the study.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change in modified Rankin Scale (mRS) score Baseline, 1 Month, 3 Months, and 6 Months Change in NIH Stroke Scale score Baseline, 1 Month, 3 Months, and 6 Months Change in Barthel Index Baseline, 1 Month, 3 Months, and 6 Months Change in Montreal Cognitive Assessment test score Baseline, 1 Month, 3 Months, and 6 Months
- Secondary Outcome Measures
Name Time Method Change in Angiographic Neovascularization Baseline and 6 Months Analyzed in digital subtraction angiography (DSA) images
Change in Angiogenic Factor Measurements Baseline, 1 Month, 3 Months, 6 Months Measured in blood, CSF, microdialysis samples, and tissue
Trial Locations
- Locations (1)
Cedars-Sinai Medical Center
🇺🇸Los Angeles, California, United States