Ischemic Brain Injury"CPR Brain"NCT00983723
Clinical Proteomic Research for the Brain
An observational study of Ischemic Brain Injury and Stroke, run by Massachusetts General Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Ischemic Brain Injury, Stroke, Healthy Individual
- How many people
- 750 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2005to Jul 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Adult with acute ischemic brain injury, adults with neurological or vascular conditions other than acute stroke and healthy adults.
Who may be able to join
- Ischemic brain injury within 12 hours of symptom onset;
- Including primary ischemic brain injury from embolism or arterial occlusion or secondary due to increased ICP after trauma, subarachnoid hemorrhage.
- Healthy adults without any neurologic or systemic disease;
- Inpatient or outpatient adults with a chronic stroke (greater than 3 months) or chronic neurologic disease such as neurodegenerative disease, movement disorder, demyelinating disease;
- Inpatient or outpatient adults with systemic vascular disease.
Who cannot join
- Patients who are hemodynamically unstable for venipunctures;
- Anemic patients (hemoglobin < 11);
- Children;
- Pregnant women.
- Controls Inclusion and Exclusion Criteria:
- Patients who are hemodynamically unstable for venipunctures;
Show all 9Show fewer
- Anemic patients (hemoglobin < 11);
- Children;
- Pregnant women.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Clinical Proteomics Research Center, Massachusetts General Hospital
Boston, Massachusetts, 02114
Mingming Ning, MD MMsc, 617-726-8459, CPRBrain@mgh.harvard.edu
MingMing Ning, M.D.
About this study
Official title: 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.
- Conditions
- Ischemic Brain Injury, Stroke, Healthy Individual, Patent Foramen Ovale (PFO), Neurovascular Injury
- Keywords
- Patient Foramen Ovale, PFO, Stroke, Ischemic Brain Injury, Neurovascular Disease
- Medical subject headings
- Stroke, Foramen Ovale, Patent
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Outcome and Biomarker Outcome
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2009 (estimated)
- Study startJul 2005
- Primary completionJul 2016 (estimated)
- Study completionJul 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ischemic Brain InjuryStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 750 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Neurological Disorders and Stroke (NINDS)
- Responsible party
- Principal investigator, Mingming Ning, MD, Massachusetts General Hospital
- Investigators
- MingMing Ning, M.D., Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00983723
- Sponsor's protocol ID
- 2005-P-001521
- Other IDs
- R01NS067139
- Acronym
- "CPR Brain"
- Status last verified
- May 2013
- First submitted
- 23 Sep 2009
- Last updated
- 23 May 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Proteomic Research on the Brain
- ClinicalTrials.gov ID
- NCT00983723
- Acronym / sponsor ID
- "CPR Brain" / 2005-P-001521
- Conditions
- Ischemic Brain Injury, Stroke, Healthy Individual, Patent Foramen Ovale (PFO), Neurovascular Injury
- Keywords
- Patient Foramen Ovale, PFO, Stroke, Ischemic Brain Injury, Neurovascular Disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 750 participants (estimated)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- National Institute of Neurological Disorders and Stroke (NINDS)
- Study start
- Jul 2005
- Primary completion
- Jul 2016 (estimated)
- Study completion
- Jul 2016 (estimated)
- First posted
- 24 Sep 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Adult with acute ischemic brain injury, adults with neurological or vascular conditions other than acute stroke and healthy adults.
Key inclusion criteria (5 listed)
- Ischemic brain injury within 12 hours of symptom onset;
- Including primary ischemic brain injury from embolism or arterial occlusion or secondary due to increased ICP after trauma, subarachnoid hemorrhage.
- Healthy adults without any neurologic or systemic disease;
- Inpatient or outpatient adults with a chronic stroke (greater than 3 months) or chronic neurologic disease such as neurodegenerative disease, movement disorder, demyelinating disease;
- Inpatient or outpatient adults with systemic vascular disease.
Key exclusion criteria (9 listed)
- Patients who are hemodynamically unstable for venipunctures;
- Anemic patients (hemoglobin < 11);
- Children;
- Pregnant women.
- Patients who are hemodynamically unstable for venipunctures;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Clinical Outcome and Biomarker Outcome
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2013.
- Clinical Proteomics Research CenterLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
MingMing Ning, M.D. principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ischemic Brain Injury and Stroke, run by Massachusetts General Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 May 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact MingMing Ning, M.D. (PI) (617-726-8459, CPRBrain@mgh.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical Outcome and Biomarker Outcome. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 May 2013.