Clinical trial NCT01705353: The Role of HMGB-1 in Chronic Stroke
Official title: Pilot Study of the Role of HMGB-1 in Retarding Recovery in Chronic Stroke
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Cerebrovascular Accident
Cerebral Stroke
Stroke, Acute
Keywords: Stroke
Cerebrovascular Accident
HMGB-1
cytokines
functional recovery
inflammation
immune response
Lead sponsor: Northwell Health
Sponsor class: OTHER
First posted: 2012-10-12
Enrollment: 39
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Acute care hospital (stroke unit)

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.

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 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

Primary outcomes:
measure: Cytokine levels (HMGB-1) in plasma samples
timeFrame: day 1, day7, day 14, day 30, day 90
Secondary outcomes:
measure: NIH and Rankin Clinical Measures of functional recovery
timeFrame: day 1, day7, day 14, day 30, day 90
Other outcomes:
Locations:
city: Manhasset
country: United States
facility: North Shore University Hospital
state: New York
city: New Hyde Park
country: United States
facility: Long Island Jewish Medical Center
state: New York
Study officials:
affiliation: Feinstein Institute for Medical Research
name: Bruce T Volpe, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Muhammad S, Barakat W, Stoyanov S, Murikinati S, Yang H, Tracey KJ, Bendszus M, Rossetti G, Nawroth PP, Bierhaus A, Schwaninger M. The HMGB1 receptor RAGE mediates ischemic brain damage. J Neurosci. 2008 Nov 12;28(46):12023-12031. doi: 10.1523/JNEUROSCI.2435-08.2008.
citation: Goldstein RS, Gallowitsch-Puerta M, Yang L, Rosas-Ballina M, Huston JM, Czura CJ, Lee DC, Ward MF, Bruchfeld AN, Wang H, Lesser ML, Church AL, Litroff AH, Sama AE, Tracey KJ. Elevated high-mobility group box 1 levels in patients with cerebral and myocardial ischemia. Shock. 2006 Jun;25(6):571-4. doi: 10.1097/01.shk.0000209540.99176.72.