The Role of HMGB-1 in Chronic Stroke

March 9, 2018 updated by: Bruce Volpe, Northwell Health

Pilot Study of the Role of HMGB-1 in Retarding Recovery in Chronic Stroke

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.

Study Overview

Status

Terminated

Conditions

Detailed Description

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.

Study Type

Observational

Enrollment (Actual)

39

Contacts and Locations

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

Study Locations

  • United States
    • New York
      • Manhasset, New York, United States, 11030
        • North Shore University Hospital
      • New Hyde Park, New York, United States, 11040
        • Long Island Jewish Medical Center

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

Non-Probability Sample

Study Population

Acute care hospital (stroke unit)

Description

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

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Cytokine levels (HMGB-1) in plasma samples
Time Frame: day 1, day7, day 14, day 30, day 90
day 1, day7, day 14, day 30, day 90

Secondary Outcome Measures

Outcome Measure
Time Frame
NIH and Rankin Clinical Measures of functional recovery
Time Frame: day 1, day7, day 14, day 30, day 90
day 1, day7, day 14, day 30, day 90

Collaborators and Investigators

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

Sponsor

Northwell Health

Investigators

  • Principal Investigator: Bruce T Volpe, MD, Feinstein Institute for Medical Research

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 (Actual)

September 1, 2012

Primary Completion (Actual)

December 1, 2017

Study Completion (Actual)

February 1, 2018

Study Registration Dates

First Submitted

October 9, 2012

First Submitted That Met QC Criteria

October 11, 2012

First Posted (Estimate)

October 12, 2012

Study Record Updates

Last Update Posted (Actual)

March 12, 2018

Last Update Submitted That Met QC Criteria

March 9, 2018

Last Verified

February 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 12-090B

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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