Genetic, Metabolic, and Growth Factor Repository for Cerebrovascular Disorders

February 6, 2023 updated by: Nestor R. Gonzalez, MD, MSCR., Cedars-Sinai Medical Center
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.

Study Overview

Status

Recruiting

Conditions

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.

Study Type

Observational

Enrollment (Anticipated)

900

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90048
        • Recruiting
        • Cedars-Sinai Medical Center
        • Contact:
        • Contact:
        • Principal Investigator:
          • Nestor R Gonzalez, MD, MSCR
        • Sub-Investigator:
          • Moise Danielpour, MD
        • Sub-Investigator:
          • Michael Alexander, MD
        • Sub-Investigator:
          • Shouri Lahiri, MD
        • Sub-Investigator:
          • Patrick Lyden, MD
        • Sub-Investigator:
          • Asma Moheet, MD
        • Sub-Investigator:
          • Axel Rosengart, MD, PhD
        • Sub-Investigator:
          • Wouter Schievink, MD
        • Sub-Investigator:
          • Konrad Schlick, MD
        • Sub-Investigator:
          • Shlee Song, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.).

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in modified Rankin Scale (mRS) score
Time Frame: Baseline, 1 Month, 3 Months, and 6 Months
Baseline, 1 Month, 3 Months, and 6 Months
Change in NIH Stroke Scale score
Time Frame: Baseline, 1 Month, 3 Months, and 6 Months
Baseline, 1 Month, 3 Months, and 6 Months
Change in Barthel Index
Time Frame: Baseline, 1 Month, 3 Months, and 6 Months
Baseline, 1 Month, 3 Months, and 6 Months
Change in Montreal Cognitive Assessment test score
Time Frame: Baseline, 1 Month, 3 Months, and 6 Months
Baseline, 1 Month, 3 Months, and 6 Months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Angiographic Neovascularization
Time Frame: Baseline and 6 Months
Analyzed in digital subtraction angiography (DSA) images
Baseline and 6 Months
Change in Angiogenic Factor Measurements
Time Frame: Baseline, 1 Month, 3 Months, 6 Months
Measured in blood, CSF, microdialysis samples, and tissue
Baseline, 1 Month, 3 Months, 6 Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cedars-Sinai Medical Center

Investigators

  • Principal Investigator: Nestor R Gonzalez, MD, MSCR, Cedars-Sinai Neurosurgery

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2016

Primary Completion (ANTICIPATED)

December 1, 2030

Study Completion (ANTICIPATED)

December 1, 2030

Study Registration Dates

First Submitted

September 14, 2016

First Submitted That Met QC Criteria

September 20, 2016

First Posted (ESTIMATE)

September 21, 2016

Study Record Updates

Last Update Posted (ACTUAL)

February 8, 2023

Last Update Submitted That Met QC Criteria

February 6, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro00045392

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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