The Role of HMGB-1 in Chronic Stroke
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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 |
- Cytokine levels (HMGB-1) in plasma samples [ Time Frame: day 1, day7, day 14, day 30, day 90 ] [ Designated as safety issue: No ]
- 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 2014 |
| Estimated Primary Completion Date: | April 2014 (Final data collection date for primary outcome measure) |
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 |
Acute care hospital (stroke unit)
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| Contact: Bruce T Volpe, MD | 516-562-3384 | bvolpe1@nshs.edu |
| Contact: Johanna Chang, MS | 516-562-3646 | jchang14@nshs.edu |
| 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 | |
| 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: | April 17, 2013 |
| 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:
|
Cerebral Infarction Stroke Brain Infarction Brain Ischemia Cerebrovascular Disorders |
Brain Diseases Central Nervous System Diseases Nervous System Diseases Vascular Diseases Cardiovascular Diseases |
ClinicalTrials.gov processed this record on May 16, 2013