Genetic, Metabolic, and Growth Factor Repository for Cerebrovascular Disorders
NCT ID: NCT02910180
Last Updated: 2023-02-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
900 participants
OBSERVATIONAL
2016-09-30
2030-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Neurogenetics Patient Registry
NCT02995538
Genetic Studies to Identify Stroke Subtypes and Outcome
NCT00357513
Cause and Pathogenesis of Neurometabolic Disorders
NCT00016562
The Parkinson's Disease NeuroGenebank at Scripps Clinic Registry
NCT00766948
Genetic and Blood Biomarkers in Neurological and Neuromuscular Diseases
NCT02780531
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
OTHER
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Repository Group
The Repository Group consists of patients which have donated tissue to the repository.
No interventions assigned to this group
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Expected availability of clinical follow up data
* Participants must be willing to provide written, informed consent obtained in accordance with institutional and federal guidelines.
Exclusion Criteria
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Cedars-Sinai Medical Center
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Nestor R. Gonzalez, MD, MSCR.
Professor of Neurosurgery
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Nestor R Gonzalez, MD, MSCR
Role: PRINCIPAL_INVESTIGATOR
Cedars-Sinai Neurosurgery
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Cedars-Sinai Medical Center
Los Angeles, California, United States
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
References
Explore related publications, articles, or registry entries linked to this study.
Mayor F, Bilgin-Freiert A, Connolly M, Katsnelson M, Dusick JR, Vespa P, Koch S, Gonzalez NR. Effects of remote ischemic preconditioning on the coagulation profile of patients with aneurysmal subarachnoid hemorrhage: a case-control study. Neurosurgery. 2013 Nov;73(5):808-15; discussion 815. doi: 10.1227/NEU.0000000000000098.
Nikkola E, Laiwalla A, Ko A, Alvarez M, Connolly M, Ooi YC, Hsu W, Bui A, Pajukanta P, Gonzalez NR. Remote Ischemic Conditioning Alters Methylation and Expression of Cell Cycle Genes in Aneurysmal Subarachnoid Hemorrhage. Stroke. 2015 Sep;46(9):2445-51. doi: 10.1161/STROKEAHA.115.009618. Epub 2015 Aug 6.
Ooi YC, Laiwalla AN, Liou R, Gonzalez NR. Angiographic Structural Differentiation between Native Arteriogenesis and Therapeutic Synangiosis in Intracranial Arterial Steno-Occlusive Disease. AJNR Am J Neuroradiol. 2016 Jun;37(6):1086-91. doi: 10.3174/ajnr.A4675. Epub 2016 Jan 21.
Bilgin-Freiert A, Dusick JR, Stein NR, Etchepare M, Vespa P, Gonzalez NR. Muscle microdialysis to confirm sublethal ischemia in the induction of remote ischemic preconditioning. Transl Stroke Res. 2012 Jun;3(2):266-72. doi: 10.1007/s12975-012-0153-1. Epub 2012 Apr 10.
Dusick J, Hamilton R, Bilgin-Freiert A, Vespa P, Hu X, Asgari S, Gonzalez NR. Immediate Cerebrovascular and Brain Metabolic Effects of Remote Ischemic Preconditioning. Stroke; a journal of cerebral circulation. 2012; 43:A2698.
Gonzalez, N. R., Liou, R. J., Rao, N., Hinman, J. D., Restrepo, L., Ali, L., … Saver, J. (2016). Abstract TP119: Angiogenic Factor Profiling in Medical Treatment of Intracranial Atherosclerosis (ICAS). Stroke, 47(Suppl 1), ATP119-ATP119.
Gonzalez, N. R., Ooi, Y., Laiwalla, A., Restrepo, L., Ali, L., Liou, R., … Saver, J. (2016). Abstract TMP15: Circulating Antiangiogenic Profile Predicts Lower Degrees of Neovascularization After Indirect Revascularization With Encephaloduroarteriosynangiosis (EDAS) in Patients With Intracranial Atherosclerosis (ICAS). Stroke, 47(Suppl 1), ATMP15-ATMP15.
Gonzalez, N. R., Connolly, M. J., Ooi, Y. C., Dusick, J., Bounni, F., Liebeskind, D. S., … Iruela-Arispe, L. (2015). Abstract 135: Angiogenic Factors and Response to Intensive Medical Management in Atherosclerotic Intracranial Arterial Stenosis. Stroke, 46(Suppl 1), A135-A135.
Gonzalez, N. R., & Iruela-Arispe, L. (2014). Abstract T P90: Characterization of Inflammatory Cells after EDAS Surgery in Patients with Intracranial Arterial Stenosis. Stroke, 45(Suppl 1), ATP90-ATP90.
Gonzalez, N. R., Liou, R., Ooi, Y., Hinman, J. D., Rao, N., Toscano, J., … Saver, J. (2016). Abstract WP138: Effects of Intensive Medical Management (IMM) and Encephaloduroarteriosynangiosis (EDAS) On VEGFA165a/b Ratios in Patients With Intracranial Atherosclerosis (ICASi. Stroke, 47(Suppl 1), AWP138-AWP138.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
Pro00045392
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.