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Clinical Proteomic Research for the Brain ("CPR Brain")

Mass General Brigham logo

Mass General Brigham

Status

Unknown

Conditions

Ischemic Brain Injury
Stroke
Healthy Individual
Neurovascular Injury
Patent Foramen Ovale (PFO)

Study type

Observational

Funder types

Other
NIH

Identifiers

NCT00983723
R01NS067139 (U.S. NIH Grant/Contract)
2005-P-001521

Details and patient eligibility

About

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.

Enrollment

750 estimated patients

Sex

All

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion criteria

Case Inclusion and Exclusion Criteria:

Inclusion Criteria:

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

Exclusion Criteria:

  1. Patients who are hemodynamically unstable for venipunctures;
  2. Anemic patients (hemoglobin < 11);
  3. Children;
  4. Pregnant women.

Controls Inclusion and Exclusion Criteria:

Inclusion Criteria:

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

Exclusion Criteria:

  1. Patients who are hemodynamically unstable for venipunctures;
  2. Anemic patients (hemoglobin < 11);
  3. Children;
  4. Pregnant women.

Trial contacts and locations

1

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Central trial contact

MingMing Ning, M.D. (PI)

Data sourced from clinicaltrials.gov

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