Genetic, Metabolic, and Growth Factor Repository for Cerebrovascular Disorders

NCT02910180 | Recruiting DMC

• 1 other identifier: Pro00045392
• Study Type: observational
• Target: 900
• Locations: 1 country
• Sites: 1

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.

Conditions

Cerebrovascular Diseases; Ischemic Stroke; Repository

Keywords

Tissue Repository; Cerebrovascular Diseases; Stroke; Aneurysm; Arteriovenous malformation; Fistula; Intracranial Stenosis; Treatment; Registry; Outcomes

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (2)

• Change in Angiographic Neovascularization

  Baseline and 6 Months

• Change in Angiogenic Factor Measurements

  Baseline, 1 Month, 3 Months, 6 Months

Study Arms (1)

Repository Group

The Repository Group consists of patients which have donated tissue to the repository.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

All patients diagnosed with cerebrovascular disease. This includes both non-surgical patients (such medically managed ischemic stroke, aneurysms, moyamoya disease, arteriovenous malformation, hemorrhagic stroke, etc.) and surgically treated patients (patients with aneurysm coiling or clipping, arteriovenous malformation resection, direct or indirect revascularization procedures for ischemia, etc.).

You may qualify if:

• 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.

You may not qualify if:

• Pregnant women are excluded from the study.

Sponsors & Collaborators

• Cedars-Sinai Medical Center: lead

Study Sites (1)

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

RECRUITING

Related Publications (10)

• 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.

  PMID: 23867300 BACKGROUND

• 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.

  PMID: 26251247 BACKGROUND

• 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.

  PMID: 26797139 BACKGROUND

• 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.

  PMID: 24323782 BACKGROUND

• 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.

  BACKGROUND

• 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.

  BACKGROUND

• 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.

  BACKGROUND

• 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.

  BACKGROUND

• 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.

  BACKGROUND

• 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.

  BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples, microdialysis samples, cerebral spinal fluid, and tissue.

MeSH Terms

Conditions

Cerebrovascular Disorders; Ischemic Stroke; Stroke; Aneurysm; Arteriovenous Malformations; Fistula

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Vascular Malformations; Cardiovascular Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Nestor R Gonzalez, MD, MSCR

  Cedars-Sinai Neurosurgery

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nestor R Gonzalez, MD, MSCR

CONTACT

(310) 423-0783; Nestor.Gonzalez@cshs.org

Patrick Lyden, MD

CONTACT

(310) 423-0894; patrick.lyden@cshs.org

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Neurosurgery

Study Record Dates

• First Submitted: September 14, 2016
• First Posted: September 21, 2016
• Study Start: September 1, 2016
• Primary Completion (Estimated): December 1, 2030
• Study Completion (Estimated): December 1, 2030
• Last Updated: February 8, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will share

Locations

US (1)