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Clinical Trials/NCT00983723
NCT00983723
Unknown
Not Applicable

Clinical Proteomic Research on the Brain

Massachusetts General Hospital1 site in 1 country750 target enrollmentJuly 2005

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Ischemic Brain Injury
Sponsor
Massachusetts General Hospital
Enrollment
750
Locations
1
Primary Endpoint
Clinical Outcome and Biomarker Outcome
Last Updated
12 years ago

Overview

Brief Summary

The study of plasma and urine proteomic profiles in patients with ischemic brain injury is important to better understanding of the mechanisms by which thrombolytic agents or other therapy affects clinical outcomes. The purpose of this study is to study the proteomic profile of patients with ischemic brain injury and compare it to control subjects without ischemic brain injury, subjects with other chronic neurologic diseases or systemic vascular diseases, and pre- and post- therapy which may be associated with, or predictive of, therapeutic outcome.

The investigators hypothesize that there is a unique set of proteins expressed in serum and urine in patients with ischemic brain injury that may provide a more complete understanding of ischemic brain injury pathophysiology.

Ultimately, this study may provide information of direct relevance to the medical care of a large proportion of patients with ischemic brain injury and other neurologic diseases in the future. And proteomic proteomic profile may provide important information about the roles of specific biomarkers. Perhaps the prevention of ischemic injury related complications.

Registry
clinicaltrials.gov
Start Date
July 2005
End Date
July 2016
Last Updated
12 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Mingming Ning, MD

Co-director, Cardio-Neurology Clinic. Director, Clinical Proteomics Research Center

Massachusetts General Hospital

Eligibility Criteria

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 (hemoglobin \< 11);
  • Pregnant women.
  • Controls Inclusion and Exclusion Criteria:
  • 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;

Outcomes

Primary Outcomes

Clinical Outcome and Biomarker Outcome

Study Sites (1)

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