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NCT Number: NCT02910180

Genetic, Metabolic, and Growth Factor Repository for Cerebrovascular Disorders

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

Location status: Recruiting

Location contact

Antoinette Anderson, BS

CONTACT

[email protected]

(310) 423-0783

Asma Moheet, MD

SUB_INVESTIGATOR

Axel Rosengart, MD, PhD

SUB_INVESTIGATOR

Konrad Schlick, MD

SUB_INVESTIGATOR

Michael Alexander, MD

SUB_INVESTIGATOR

Moise Danielpour, MD

SUB_INVESTIGATOR

Nestor R Gonzalez, MD, MSCR

CONTACT

[email protected]

310-423-0783

Nestor R Gonzalez, MD, MSCR

PRINCIPAL_INVESTIGATOR

Patrick Lyden, MD

SUB_INVESTIGATOR

Shlee Song, MD

SUB_INVESTIGATOR

Shouri Lahiri, MD

SUB_INVESTIGATOR

Wouter Schievink, MD

SUB_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Change in modified Rankin Scale (mRS) score

    Time frame: Baseline, 1 Month, 3 Months, and 6 Months

  2. Change in NIH Stroke Scale score

    Time frame: Baseline, 1 Month, 3 Months, and 6 Months

  3. Change in Barthel Index

    Time frame: Baseline, 1 Month, 3 Months, and 6 Months

  4. Change in Montreal Cognitive Assessment test score

    Time frame: Baseline, 1 Month, 3 Months, and 6 Months

Secondary outcomes

  1. Change in Angiographic Neovascularization

    Time frame: Baseline and 6 Months

    Analyzed in digital subtraction angiography (DSA) images

  2. Change in Angiogenic Factor Measurements

    Time frame: Baseline, 1 Month, 3 Months, 6 Months

    Measured in blood, CSF, microdialysis samples, and tissue

Study contacts

Contact information is provided by the study sponsor or research team.

Nestor R Gonzalez, MD, MSCR

CONTACT

[email protected]

(310) 423-0783

Patrick Lyden, MD

CONTACT

[email protected]

(310) 423-0894

Sponsors and collaborators

Lead sponsor

Cedars-Sinai Medical Center

Other

Registry information

Important dates

Study start
2016
Primary completion
2030
Study completion
2030
First posted
Sep 21, 2016
Registry last updated
Feb 8, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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