Clinical trial NCT00983723: Clinical Proteomic Research for the Brain
Official title: Clinical Proteomic Research on the Brain
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Ischemic Brain Injury
Stroke
Healthy Individual
Patent Foramen Ovale (PFO)
Neurovascular Injury
Keywords: Patient Foramen Ovale
PFO
Stroke
Ischemic Brain Injury
Neurovascular Disease
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: National Institute of Neurological Disorders and Stroke (NINDS)
First posted: 2009-09-24
Enrollment: 750
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Clinical Outcome and Biomarker Outcome
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Clinical Proteomics Research Center, Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: MingMing Ning, M.D.
role: PRINCIPAL_INVESTIGATOR
References: