The Role of HMGB-1 in Chronic Stroke

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by North Shore Long Island Jewish Health System
Sponsor:
Information provided by (Responsible Party):
Bruce Volpe, North Shore Long Island Jewish Health System
ClinicalTrials.gov Identifier:
NCT01705353
First received: October 9, 2012
Last updated: January 16, 2014
Last verified: January 2014
  Purpose

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
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 North Shore Long Island Jewish Health System:

Primary Outcome Measures:
  • Cytokine levels (HMGB-1) in plasma samples [ Time Frame: day 1, day7, day 14, day 30, day 90 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • NIH and Rankin Clinical Measures of functional recovery [ Time Frame: day 1, day7, day 14, day 30, day 90 ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

Whole blood, DNA, serum/serum cytokines


Estimated Enrollment: 100
Study Start Date: September 2012
Estimated Study Completion Date: April 2015
Estimated Primary Completion Date: April 2015 (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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Acute care hospital (stroke unit)

Criteria

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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01705353

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

Locations
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
North Shore Long Island Jewish Health System
Investigators
Principal Investigator: Bruce T Volpe, MD Feinstein Institute for Medical Research
  More Information

Publications:
Responsible Party: Bruce Volpe, Investigator (MD), North Shore Long Island Jewish Health System
ClinicalTrials.gov Identifier: NCT01705353     History of Changes
Other Study ID Numbers: 12-090B
Study First Received: October 9, 2012
Last Updated: January 16, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by North Shore Long Island Jewish Health System:
Stroke
Cerebrovascular Accident
HMGB-1
cytokines
functional recovery
inflammation
immune response

Additional relevant MeSH terms:
Stroke
Cerebral Infarction
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Brain Infarction
Brain Ischemia

ClinicalTrials.gov processed this record on September 18, 2014