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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT01705353
Other study ID # 12-090B
Secondary ID
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
Health authority
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

Study Design


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
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