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Clinical Proteomic Research for the Brain (CPR)
This study is currently recruiting participants.
Verified by National Institute of Neurological Disorders and Stroke (NINDS), January 2009
Sponsors and Collaborators: Massachusetts General Hospital
National Institute of Neurological Disorders and Stroke (NINDS)
Information provided by: National Institute of Neurological Disorders and Stroke (NINDS)
ClinicalTrials.gov Identifier: NCT00682331
  Purpose

The purpose of this research is to study the proteomic profile of individuals with ischemic brain injury. By comparing acute ischemic injury to other neurological diseases or systemic vascular injuries, researchers hope to further the understanding of ischemic brain injury.


Condition
Ischemic Brain Injury
Stroke
Proteomics

MedlinePlus related topics: Neurologic Diseases Traumatic Brain Injury
U.S. FDA Resources
Study Type: Observational
Study Design: Cohort, Prospective
Official Title: Clinical Proteomic Research for the Brain

Further study details as provided by National Institute of Neurological Disorders and Stroke (NINDS):

Primary Outcome Measures:
  • In patients treated w/ thrombolytic agents/other therapy, the plasma/urine proteomic profiles will differ between pre- & post-therapy, indicating a characteristic therapy-induced state, which may be associated with/predictive of, therapeutic outcome. [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

Biospecimen Description:

blood samples and urine samples will be collected for protein analysis


Estimated Enrollment: 150
Study Start Date: July 2005
Estimated Study Completion Date: May 2010
Estimated Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
controls
Healthy Volunteers
acute ischemic brain injury patients
acute ischemic brain injury patients meeting inclusion criteria

Detailed Description:

The purpose of this study is to learn how the brain responds to vascular injuries such as stroke and/or to various medical or surgical treatments. The researchers will do this by examining naturally occurring proteins in the blood and urine using state-of-the-art proteomics techniques.

Proteomics enables a "snapshot" of the body's chemistry at a specific time, either as part of normal daily function, or in response to a disease or treatment. Studying these snapshots will help scientists to better understand how people react to neurological disorders and treatments (such as thrombolysis or other interventions to save damaged brain).

In the future, this knowledge may allow scientists to better tailor treatments, or to find the treatment that will be best for an individual person. The long-term goal is to use these snapshots to improve the ability to guide potentially life-saving therapy with a risky profile such as tissue plasminogen activator, or tPA, and finding new targets of intervention.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Participants will be referred from the inpatient setting of the MGH primary care clinical, cardiology clinic, neurodegenerative disease/movement disorders clinic or other outpatient settings

Criteria

CASE:

Inclusion Criteria:

  • Ischemic brain injury within 12 hours of symptom onset
  • Including primary ischemic brain injury from embolism or arterial occlusion or secondary due to increased ICP after trauma, subarachnoid hemorrhage.

Exclusion Criteria:

  • Patients who are hemodynamically unstable for venipunctures
  • Anemic patients
  • Children
  • Pregnant women

CONTROLS:

Inclusion Criteria:

  • Healthy adults without any neurologic or systemic disease
  • Inpatient or outpatient adults with a chronic stroke (greater than 3 months) or chronic neurologic disease such as neurodegenerative disease, movement disorder, demyelinating disease
  • Inpatient or outpatient adults with systemic vascular disease.

Exclusion Criteria:

  • Patients who are hemodynamically unstable for venipunctures
  • Anemic patients
  • Children
  • Pregnant women
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00682331

Contacts
Contact: Dayse Sena, MD, PhD 617-643-4637 dsena@partners.org

Locations
United States, Massachusetts
Clinical Proteomic Research Center, Department of Neurology, ACC720, 55 Fruit Street, Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 01124
Contact: MingMing Ning, MD     617-724-0960     MMNING@partners.org    
Principal Investigator: MingMing Ning, MD            
Sponsors and Collaborators
Massachusetts General Hospital
Investigators
Principal Investigator: MingMing Ning, MD Massachusetts General Hospital
  More Information

Responsible Party: Massachusetts General Hospital ( MingMing Ning, MD, Clinical Proteomic Research Center )
Study ID Numbers: K23NS051588, MGH 2005-P-001521, NS051588
Study First Received: May 20, 2008
Last Updated: January 6, 2009
ClinicalTrials.gov Identifier: NCT00682331  
Health Authority: United States: Federal Government

Keywords provided by National Institute of Neurological Disorders and Stroke (NINDS):
Ischemic brain injury
Stroke
Proteomics
biomarker

Study placed in the following topic categories:
Craniocerebral Trauma
Cerebral Infarction
Stroke
Vascular Diseases
Wounds and Injuries
Central Nervous System Diseases
Disorders of Environmental Origin
Ischemia
Trauma, Nervous System
Brain Diseases
Cerebrovascular Disorders
Brain Ischemia
Brain Injuries

Additional relevant MeSH terms:
Nervous System Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 16, 2009