Genetic, Metabolic, and Growth Factor Repository for Cerebrovascular Disorders

Ischemic Stroke Clinical Trial

Official title:

Genetic, Metabolic, and Growth Factor Repository for Cerebrovascular Disorders

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02910180
• Other study ID #: Pro00045392
• Status: Recruiting
• Start date: September 2016
• Est. completion date: December 2030

Study information

• Verified date: February 2023
• Source: Cedars-Sinai Medical Center
• Contact: Nestor R Gonzalez, MD, MSCR
• Phone: (310) 423-0783
• Email: Nestor.Gonzalez[@]cshs.org
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 900
• Est. completion date: December 2030
• Est. primary completion date: December 2030
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• Pregnant women are excluded from the study.

Related Conditions & MeSH terms

• Cerebrovascular Diseases
• Cerebrovascular Disorders
• Ischemic Stroke
• Repository

Locations

Country	Name	City	State
United States	Cedars-Sinai Medical Center	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
Cedars-Sinai Medical Center

Country where clinical trial is conducted

United States, 

References & Publications (10)

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. — View Citation

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., & 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., 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., 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., 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.

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.

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in modified Rankin Scale (mRS) score		Baseline, 1 Month, 3 Months, and 6 Months
Primary	Change in NIH Stroke Scale score		Baseline, 1 Month, 3 Months, and 6 Months
Primary	Change in Barthel Index		Baseline, 1 Month, 3 Months, and 6 Months
Primary	Change in Montreal Cognitive Assessment test score		Baseline, 1 Month, 3 Months, and 6 Months
Secondary	Change in Angiographic Neovascularization	Analyzed in digital subtraction angiography (DSA) images	Baseline and 6 Months
Secondary	Change in Angiogenic Factor Measurements	Measured in blood, CSF, microdialysis samples, and tissue	Baseline, 1 Month, 3 Months, 6 Months