We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov Menu

The Role of HMGB-1 in Chronic Stroke

This study is currently recruiting participants.
Verified October 2017 by Bruce Volpe, Northwell Health
ClinicalTrials.gov Identifier:
First Posted: October 12, 2012
Last Update Posted: October 19, 2017
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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Bruce Volpe, Northwell Health
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.

Cerebrovascular Accident Cerebral Stroke Stroke, Acute

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Pilot Study of the Role of HMGB-1 in Retarding Recovery in Chronic Stroke

Further study details as provided by Bruce Volpe, Northwell Health:

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

Secondary Outcome Measures:
  • 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

Estimated Enrollment: 100
Study Start Date: September 2012
Estimated Study Completion Date: August 2020
Estimated Primary Completion Date: August 2020 (Final data collection date for primary outcome measure)
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.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT01705353

Contact: Bruce T Volpe, MD 516-562-3384 bvolpe1@nshs.edu
Contact: Johanna Chang, MS 516-562-3646 jchang14@nshs.edu

United States, New York
North Shore University Hospital Recruiting
Manhasset, New York, United States, 11030
Long Island Jewish Medical Center Recruiting
New Hyde Park, New York, United States, 11040
Sponsors and Collaborators
Northwell Health
Principal Investigator: Bruce T Volpe, MD Feinstein Institute for Medical Research
  More Information

Responsible Party: Bruce Volpe, Investigator (MD), Northwell Health
ClinicalTrials.gov Identifier: NCT01705353     History of Changes
Other Study ID Numbers: 12-090B
First Submitted: October 9, 2012
First Posted: October 12, 2012
Last Update Posted: October 19, 2017
Last Verified: October 2017

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