The Role of HMGB-1 in Chronic Stroke

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01705353
Recruitment Status : Terminated (study stopped because patient access became extremely limited for the initial data entry point.)
First Posted : October 12, 2012
Last Update Posted : March 12, 2018
Information provided by (Responsible Party):
Bruce Volpe, Northwell Health

Brief Summary:
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.

Condition or disease
Cerebrovascular Accident Cerebral Stroke Stroke, Acute

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
Actual Enrollment : 39 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Pilot Study of the Role of HMGB-1 in Retarding Recovery in Chronic Stroke
Actual Study Start Date : September 2012
Primary Completion Date : December 2017
Study Completion Date : February 2018

Primary Outcome Measures :
  1. Cytokine levels (HMGB-1) in plasma samples [ Time Frame: day 1, day7, day 14, day 30, day 90 ]

Secondary Outcome Measures :
  1. NIH and Rankin Clinical Measures of functional recovery [ Time Frame: day 1, day7, day 14, day 30, day 90 ]

Biospecimen Retention:   Samples With DNA
Whole blood, DNA, serum/serum cytokines

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Acute care hospital (stroke unit)

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01705353

United States, New York
North Shore University Hospital
Manhasset, New York, United States, 11030
Long Island Jewish Medical Center
New Hyde Park, New York, United States, 11040
Sponsors and Collaborators
Northwell Health
Principal Investigator: Bruce T Volpe, MD Feinstein Institute for Medical Research
  Study Documents (Full-Text)

Documents provided by Bruce Volpe, Northwell Health:

Responsible Party: Bruce Volpe, Investigator (MD), Northwell Health Identifier: NCT01705353     History of Changes
Other Study ID Numbers: 12-090B
First Posted: October 12, 2012    Key Record Dates
Last Update Posted: March 12, 2018
Last Verified: February 2018

Keywords provided by Bruce Volpe, Northwell Health:
Cerebrovascular Accident
functional recovery
immune response

Additional relevant MeSH terms:
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases