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The Role of HMGB-1 in Chronic Stroke

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ClinicalTrials.gov 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
Sponsor:
Information provided by (Responsible Party):
Bruce Volpe, Northwell Health

October 9, 2012
October 12, 2012
March 12, 2018
September 2012
December 2017   (Final data collection date for primary outcome measure)
Cytokine levels (HMGB-1) in plasma samples [ Time Frame: day 1, day7, day 14, day 30, day 90 ]
Not Provided
Complete list of historical versions of study NCT01705353 on ClinicalTrials.gov Archive Site
NIH and Rankin Clinical Measures of functional recovery [ Time Frame: day 1, day7, day 14, day 30, day 90 ]
Not Provided
Not Provided
Not Provided
 
The Role of HMGB-1 in Chronic Stroke
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.
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.
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:
Whole blood, DNA, serum/serum cytokines
Non-Probability Sample
Acute care hospital (stroke unit)
  • Cerebrovascular Accident
  • Cerebral Stroke
  • Stroke, Acute
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
39
100
February 2018
December 2017   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01705353
12-090B
Yes
Not Provided
Not Provided
Bruce Volpe, Northwell Health
Northwell Health
Not Provided
Principal Investigator: Bruce T Volpe, MD Feinstein Institute for Medical Research
Northwell Health
February 2018