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Clinical Trials/NCT00983723
NCT00983723UnknownNot Applicable

Clinical Proteomic Research on the Brain

Massachusetts General Hospital1 site in 1 country750 target enrollmentStarted: July 2005Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Enrollment
750
Locations
1
Primary Endpoint
Clinical Outcome and Biomarker Outcome

Study 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.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Sex
All
Accepts Healthy Volunteers
Yes

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;
  • Anemic patients (hemoglobin < 11);
  • Pregnant women.

Outcomes

Primary Outcomes

Clinical Outcome and Biomarker Outcome

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Mingming Ning, MD

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

Massachusetts General Hospital

Study Sites (1)

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