Recruiting

Observational Study

Sponsor:

Massachusetts General Hospital

Code:

NCT00983723

Conditions

Ischemic Brain Injury

Stroke

Healthy Individual

Patent Foramen Ovale (PFO)

Neurovascular Injury

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Accepted

Study Details

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

Study ID

NCT00983723

Start date

Jul, 2005

Status verified date

May, 2013

Completion date

Jul, 2016

Anticipated

Primary completion date

Jul, 2016

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Accepted

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

Enrollment

750 participants

Anticipated

Interventions and Outcome Measures

Primary outcome measure

  • Clinical Outcome and Biomarker Outcome [ Time Frame: undefined ]

Central Contacts and Locations

Central contacts

MingMing Ning, M.D. (PI)

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

Locations

Clinical Proteomics Research Center, Massachusetts General Hospital

Recruiting

Boston, Massachusetts, United States, 02114

Contacts

Mingming Ning, MD MMsc

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

Principal Investigator:

MingMing Ning, M.D.

More Information

Sponsor

Massachusetts General Hospital

Last update posted

May 23, 2013

Last verified

May, 2013

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Massachusetts General Hospital on 2013-05-23.