Clinical Proteomic Research for the Brain

NCT ID: NCT00983723

Last Updated: 2013-05-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

750 participants

Study Classification

OBSERVATIONAL

Study Start Date

2005-07-31

Study Completion Date

2016-07-31

Brief Summary

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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

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Conditions

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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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.


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.



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

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institute of Neurological Disorders and Stroke (NINDS)

NIH

Sponsor Role collaborator

Massachusetts General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Mingming Ning, MD

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

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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MingMing Ning, M.D.

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Locations

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Clinical Proteomics Research Center, Massachusetts General Hospital

Boston, Massachusetts, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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MingMing Ning, M.D. (PI)

Role: CONTACT

617-726-8459

Facility Contacts

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Mingming Ning, MD MMsc

Role: primary

617-726-8459

Related Links

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Other Identifiers

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R01NS067139

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2005-P-001521

Identifier Type: -

Identifier Source: org_study_id

NCT00682331

Identifier Type: -

Identifier Source: nct_alias

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