Cerebrovascular AccidentNCT01705353
The Role of HMGB-1 in Chronic Stroke
An observational study of Cerebrovascular Accident and Cerebral Stroke, run by Northwell Health at 2 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cerebrovascular Accident, Cerebral Stroke, Stroke, Acute
- How many people
- 39 participants
- Where
- 2 sitesUnited States
- Study dates
- Sep 2012to Feb 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Acute care hospital (stroke unit)
Who may be able to join
- Patients admitted to the stroke service at Northshore and LIJ Medical Centers
- Patients 18 years of age or older
Who cannot join
- Patients < 18 years of age
Trial locations and contacts
2 sites in 1 country.
United States2 sites
North Shore University Hospital
Manhasset, New York, 11030
Long Island Jewish Medical Center
New Hyde Park, New York, 11040
About this study
Official title: 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.
Read the 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.
- Conditions
- Cerebrovascular Accident, Cerebral Stroke, Stroke, Acute
- Keywords
- Stroke, Cerebrovascular Accident, HMGB-1, cytokines, functional recovery, inflammation, immune response
- Medical subject headings
- Stroke, Inflammation
What is being measured
The primary outcome is the main question the study is designed to answer.
Cytokine levels (HMGB-1) in plasma samples
Measured: day 1, day7, day 14, day 30, day 90
Secondary outcomes (1)
NIH and Rankin Clinical Measures of functional recovery
Measured: day 1, day7, day 14, day 30, day 90
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2012 (estimated)
- Study startSep 2012
- Primary completionDec 2017
- Study completionFeb 2018
Why it stopped: study stopped because patient access became extremely limited for the initial data entry point.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Cerebrovascular AccidentStudies of the same condition, open and under way.
- More trials run by Northwell HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwell Health
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bruce Volpe, Northwell Health
- Investigators
- Bruce T Volpe, MD, Principal investigator, Feinstein Institute for Medical Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01705353
- Sponsor's protocol ID
- 12-090B
- Status last verified
- Feb 2018
- First submitted
- 9 Oct 2012
- Last updated
- 12 Mar 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 19005067Goldstein 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.
PubMed 16721263
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of the Role of HMGB-1 in Retarding Recovery in Chronic Stroke
- ClinicalTrials.gov ID
- NCT01705353
- Acronym / sponsor ID
- 12-090B
- Conditions
- Cerebrovascular Accident, Cerebral Stroke, Stroke, Acute
- Keywords
- Stroke, Cerebrovascular Accident, HMGB-1, cytokines, functional recovery, inflammation, immune response
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: study stopped because patient access became extremely limited for the initial data entry point.
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Northwell HealthUniversity, hospital or other
- Study start
- Sep 2012 (actual)
- Primary completion
- Dec 2017 (actual)
- Study completion
- Feb 2018 (actual)
- First posted
- 12 Oct 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Acute care hospital (stroke unit)
Key inclusion criteria (2 listed)
- Patients admitted to the stroke service at Northshore and LIJ Medical Centers
- Patients 18 years of age or older
Key exclusion criteria (1 listed)
- Patients < 18 years of age
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Cytokine levels (HMGB-1) in plasma samples
Time frame: day 1, day7, day 14, day 30, day 90
1 secondary outcome
NIH and Rankin Clinical Measures of functional recovery
Time frame: day 1, day7, day 14, day 30, day 90
Results and safety
The study was stopped early (reason given: study stopped because patient access became extremely limited for the initial data entry point.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2018.
- Background: PubMed 19005067Muhammad 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.
- Background: PubMed 16721263Goldstein 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bruce T Volpe, MD principal investigator
Feinstein Institute for Medical Research
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cerebrovascular Accident and Cerebral Stroke, run by Northwell Health at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 12 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: study stopped because patient access became extremely limited for the initial data entry point.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cytokine levels (HMGB-1) in plasma samples (time frame: day 1, day7, day 14, day 30, day 90). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01705353, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2018.