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
  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

Resource links provided by NLM:


Further study details as provided by 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

Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
Investigators
Principal Investigator: MingMing Ning, M.D. Massachusetts General Hospital
  More Information

Additional Information:
No publications provided

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
Study First Received: September 23, 2009
Last Updated: May 22, 2013
Health Authority: United States: Federal Government

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

Additional relevant MeSH terms:
Foramen Ovale, Patent
Ischemia
Stroke
Brain Injuries
Wounds and Injuries
Heart Septal Defects, Atrial
Heart Septal Defects
Heart Defects, Congenital
Cardiovascular Abnormalities
Cardiovascular Diseases
Heart Diseases
Congenital Abnormalities
Pathologic Processes
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Craniocerebral Trauma
Trauma, Nervous System

ClinicalTrials.gov processed this record on July 22, 2014