The Role of HMGB-1 in Chronic Stroke

Stroke, Acute Clinical Trial

Official title:

Pilot Study of the Role of HMGB-1 in Retarding Recovery in Chronic Stroke

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01705353
• Other study ID #: 12-090B
• Status: Terminated
• Phase: N/A
• First received: October 9, 2012
• Last updated: March 9, 2018
• Start date: September 2012
• Est. completion date: February 2018

Study information

• Verified date: February 2018
• Source: Northwell Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 39
• Est. completion date: February 2018
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cerebral Stroke
• Cerebrovascular Accident
• Stroke
• Stroke, Acute

Locations

Country	Name	City	State
United States	North Shore University Hospital	Manhasset	New York
United States	Long Island Jewish Medical Center	New Hyde Park	New York

Sponsors (1)

Lead Sponsor	Collaborator
Northwell Health

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cytokine levels (HMGB-1) in plasma samples		day 1, day7, day 14, day 30, day 90
Secondary	NIH and Rankin Clinical Measures of functional recovery		day 1, day7, day 14, day 30, day 90