Clinical Proteomic Research for the Brain

NCT00983723 | Unknown DMC

• 2 other identifiers: 2005-P-001521R01NS067139
• Study Type: observational
• Target: 750
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Patient Foramen Ovale; PFO; Stroke; Ischemic Brain Injury; Neurovascular Disease

Outcome Measures

Primary Outcomes (1)

• Clinical Outcome and Biomarker Outcome

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult with acute ischemic brain injury, adults with neurological or vascular conditions other than acute stroke and healthy adults.

You may not qualify if:

• 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.
• Patients who are hemodynamically unstable for venipunctures;
• Anemic patients (hemoglobin \< 11);
• Children;
• Pregnant women.
• 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.
• Patients who are hemodynamically unstable for venipunctures;
• Anemic patients (hemoglobin \< 11);
• Children;
• Pregnant women.

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• National Institute of Neurological Disorders and Stroke (NINDS): collaborator

Study Sites (1)

Clinical Proteomics Research Center, Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

RECRUITING

Related Links

• Clinical Proteomics Research Center

MeSH Terms

Conditions

Stroke; Foramen Ovale, Patent

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Heart Septal Defects, Atrial; Heart Septal Defects; Heart Defects, Congenital; Cardiovascular Abnormalities; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• MingMing Ning, M.D.

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

MingMing Ning, M.D. (PI)

CONTACT

617-726-8459; CPRBrain@mgh.harvard.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Co-director, Cardio-Neurology Clinic. Director, Clinical Proteomics Research Center

Study Record Dates

• First Submitted: September 23, 2009
• First Posted: September 24, 2009
• Study Start: July 1, 2005
• Primary Completion: July 1, 2016
• Study Completion: July 1, 2016
• Last Updated: May 23, 2013

Record last verified: 2013-05

Locations

US (1)