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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified May 2013 by Mingming Ning, MD, Massachusetts General Hospital.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00983723
First Posted: September 24, 2009
Last Update Posted: May 23, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Institute of Neurological Disorders and Stroke (NINDS)
Information provided by (Responsible Party):
Mingming Ning, MD, Massachusetts General Hospital
  Purpose

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.


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

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Clinical Proteomic Research on the Brain

Further study details as provided by Mingming Ning, MD, Massachusetts General Hospital:

Primary Outcome Measures:
  • Clinical Outcome and Biomarker Outcome

Estimated Enrollment: 750
Study Start Date: July 2005
Estimated Study Completion Date: July 2016
Estimated Primary Completion Date: July 2016 (Final data collection date for primary outcome measure)
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00983723


Contacts
Contact: MingMing Ning, M.D. (PI) 617-726-8459 CPRBrain@mgh.harvard.edu

Locations
United States, Massachusetts
Clinical Proteomics Research Center, Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Mingming Ning, MD MMsc    617-726-8459    CPRBrain@mgh.harvard.edu   
Principal Investigator: MingMing Ning, M.D.         
Sub-Investigator: Ferdinando Buonanno, M.D.         
Sub-Investigator: Eng H Lo, PhD         
Sponsors and Collaborators
Massachusetts General Hospital
National Institute of Neurological Disorders and Stroke (NINDS)
Investigators
Principal Investigator: MingMing Ning, M.D. Massachusetts General Hospital
  More Information

Additional Information:
Responsible Party: Mingming Ning, MD, Co-director, Cardio-Neurology Clinic. Director, Clinical Proteomics Research Center, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00983723     History of Changes
Obsolete Identifiers: NCT00682331
Other Study ID Numbers: 2005-P-001521
R01NS067139 ( U.S. NIH Grant/Contract )
First Submitted: September 23, 2009
First Posted: September 24, 2009
Last Update Posted: May 23, 2013
Last Verified: May 2013

Keywords provided by Mingming Ning, MD, Massachusetts General Hospital:
Patient Foramen Ovale
PFO
Stroke
Ischemic Brain Injury
Neurovascular Disease

Additional relevant MeSH terms:
Wounds and Injuries
Brain Injuries
Foramen Ovale, Patent
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Heart Septal Defects, Atrial
Heart Septal Defects
Heart Defects, Congenital
Cardiovascular Abnormalities
Cardiovascular Diseases
Heart Diseases
Congenital Abnormalities


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