Clinical Proteomic Research for the Brain

• Conditions: Ischemic Brain Injury; Stroke; Healthy Individual; Patent Foramen Ovale (PFO); Neurovascular Injury

• Registration Number: NCT00983723
• Lead Sponsor: Massachusetts General Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-07
• Study First Submitted: 2009-09-23
• Study First Submitted QC: 2009-09-23
• Study First Posted: 2009-09-24
• Status Verified: 2013-05
• Last Update Submitted: 2013-05-22
• Last Update Posted: 2013-05-23
• Primary Completion: 2016-07
• Study Completion: 2016-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 750

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Clinical Outcome and Biomarker Outcome

Trial Locations

Locations (1)

Clinical Proteomics Research Center, Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States