Clinical Proteomic Research for the Brain

Stroke Clinical Trial

— "CPR Brain"  

Official title:

Clinical Proteomic Research on the Brain

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00983723
• Other study ID #: 2005-P-001521
• Secondary ID: R01NS067139
• Status: Recruiting
• Phase: N/A
• First received: September 23, 2009
• Last updated: May 22, 2013
• Start date: July 2005
• Est. completion date: July 2016

Study information

• Verified date: May 2013
• Source: Massachusetts General Hospital
• Contact: MingMing Ning, M.D. (PI)
• Phone: 617-726-8459
• Email: CPRBrain[@]mgh.harvard.edu
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Observational

Clinical Trial 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.

Other known NCT identifiers

• NCT00682331

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 750
• Est. completion date: July 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A and older

Eligibility

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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

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

Locations

Country	Name	City	State
United States	Clinical Proteomics Research Center, Massachusetts General Hospital	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Massachusetts General Hospital	National Institute of Neurological Disorders and Stroke (NINDS)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical Outcome and Biomarker Outcome

External Links

•   Clinical Proteomics Research Center