Clinical Proteomic Research for the Brain ("CPR Brain")

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2013 by Massachusetts General Hospital
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Mingming Ning, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT00983723
First received: September 23, 2009
Last updated: May 22, 2013
Last verified: May 2013

September 23, 2009
May 22, 2013
July 2005
July 2016   (final data collection date for primary outcome measure)
Clinical Outcome and Biomarker Outcome
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Complete list of historical versions of study NCT00983723 on ClinicalTrials.gov Archive Site
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Clinical Proteomic Research for the Brain
Clinical Proteomic Research on the Brain

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.

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Observational
Observational Model: Cohort
Time Perspective: Prospective
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Non-Probability Sample

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

  • Ischemic Brain Injury
  • Stroke
  • Healthy Individual
  • Patent Foramen Ovale (PFO)
  • Neurovascular Injury
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
750
July 2016
July 2016   (final data collection date for primary outcome measure)

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.
Both
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Yes
Contact: MingMing Ning, M.D. (PI) 617-726-8459 CPRBrain@mgh.harvard.edu
United States
 
NCT00983723
2005-P-001521, R01NS067139
Yes
Mingming Ning, MD, Massachusetts General Hospital
Massachusetts General Hospital
National Institute of Neurological Disorders and Stroke (NINDS)
Principal Investigator: MingMing Ning, M.D. Massachusetts General Hospital
Massachusetts General Hospital
May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP