The Role of HMGB-1 in Chronic Stroke

NCT ID: NCT01705353

Last Updated: 2018-03-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

39 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-09-30

Study Completion Date

2018-02-28

Brief Summary

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The purpose of this study is to measure the presence of HMGB-1 and other proteins in the blood across five time points after stroke, and to determine if their presence correlates with rate of stroke recovery.

Detailed Description

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Stroke, cerebrovascular accident, is the leading cause of brain injury and the leading cause of permanent disability. The acute pathophysiology of stroke depends on the innate immune response, which arises from mostly pro-inflammatory cascades. The chronic pathophysiology of stroke is less clear as the innate inflammatory response fades and matures into an adaptive immune response. HMGB-1 is a serum cytokine that has been found with persistent elevated levels for weeks to months after neurological insult in preclinical experiments, and may retard functional recovery. Elucidation of the relationship between HMGB-1 levels and the rate of functional recovery after stroke could lead to a better understanding of the systemic inflammatory response and more targeted therapeutic interventions.

Conditions

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Cerebrovascular Accident Cerebral Stroke Stroke, Acute

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* Patients admitted to the stroke service at Northshore and LIJ Medical Centers
* Patients 18 years of age or older

Exclusion Criteria

* Patients \< 18 years of age
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Northwell Health

OTHER

Sponsor Role lead

Responsible Party

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Bruce Volpe

Investigator (MD)

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Bruce T Volpe, MD

Role: PRINCIPAL_INVESTIGATOR

Feinstein Institute for Medical Research

Locations

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North Shore University Hospital

Manhasset, New York, United States

Site Status

Long Island Jewish Medical Center

New Hyde Park, New York, United States

Site Status

Countries

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United States

References

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Muhammad S, Barakat W, Stoyanov S, Murikinati S, Yang H, Tracey KJ, Bendszus M, Rossetti G, Nawroth PP, Bierhaus A, Schwaninger M. The HMGB1 receptor RAGE mediates ischemic brain damage. J Neurosci. 2008 Nov 12;28(46):12023-12031. doi: 10.1523/JNEUROSCI.2435-08.2008.

Reference Type BACKGROUND
PMID: 19005067 (View on PubMed)

Goldstein RS, Gallowitsch-Puerta M, Yang L, Rosas-Ballina M, Huston JM, Czura CJ, Lee DC, Ward MF, Bruchfeld AN, Wang H, Lesser ML, Church AL, Litroff AH, Sama AE, Tracey KJ. Elevated high-mobility group box 1 levels in patients with cerebral and myocardial ischemia. Shock. 2006 Jun;25(6):571-4. doi: 10.1097/01.shk.0000209540.99176.72.

Reference Type BACKGROUND
PMID: 16721263 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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12-090B

Identifier Type: -

Identifier Source: org_study_id

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