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Diagnostic Utility of MRI in Intracerebral Hemorrhage

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. Identifier: NCT00363662
Recruitment Status : Unknown
Verified June 2012 by Stanford University.
Recruitment status was:  Recruiting
First Posted : August 15, 2006
Last Update Posted : June 13, 2012
Information provided by (Responsible Party):
Stanford University

Brief Summary:
The overall aim of this project is to prospectively determine whether MRI can improve the conventional neuroradiological evaluation (CT with or without cerebral angiography) of patients with a spontaneous ICH or IVH. The study design will also allow us to identify the added benefit of specific MR sequences and repeat MRI in the chronic stage, thereby allowing us to prospectively determine their value in a consecutive series of patients. This information should have a major impact on the management of these patients by providing data on the diagnostic yield of routine MRI in patients presenting with a wide variety of causes for ICH or IVH. These data will help guide the diagnostic evaluation and the management of brain hemorrhage patients in the future.

Condition or disease
Cerebral Hemorrhage

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Study Type : Observational
Estimated Enrollment : 160 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Diagnostic Utility of MRI in Intracerebral Hemorrhage
Study Start Date : June 2006
Estimated Primary Completion Date : April 2013
Estimated Study Completion Date : April 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bleeding

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
A total of 180 ICH or IVH patients will be studied. All patients will be inpatients admitted to the Stanford Stroke Center, a multidisciplinary referral center for the treatment of acute stroke. Consecutive patients will be enrolled provided they meet the inclusion and exclusion criteria and that they or a legally authorized representative give informed consent.

Inclusion Criteria:

A. Men and non-pregnant women, at least 18 years of age.

B. Patients with an ICH or IVH admitted to Stanford University Medical center within 48 hours of symptom onset.

C. Ability to undergo MRI.

Exclusion Criteria:

A. Patients with a known (preexisting) source for ICH, for example a known untreated arterio-venous malformation.

B. Patients receiving investigational drug therapies or procedures prior to MRI scanning.

C. Glasgow coma scale (GCS) score < 6 in the absence of sedating medications.

D. Informed consent cannot be obtained either directly from the patient or from a legally authorized representative.

E. Severe coexisting or terminal systemic disease that limits life expectancy or that may interfere with the conduct of the study

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 identifier (NCT number): NCT00363662

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Contact: Stephanie M Kemp, BS (650) 723-4481

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United States, California
Stanford University School of Medicine Recruiting
Stanford, California, United States, 94305
Contact: Stephanie M Kemp, BS    650-723-4481   
Contact: Eyngorn, MD    (650) 498-7333   
Principal Investigator: Christine Wijman         
Sub-Investigator: Gregory W Albers         
Sub-Investigator: Michael E. Moseley         
Sub-Investigator: Maarten G Lansberg MD, PhD         
Sub-Investigator: Anna K. Finley Caulfield         
Sub-Investigator: Neil Schwartz         
Sub-Investigator: Dr Marion S Buckwalter         
Sub-Investigator: Dr. chitra venkat         
Sub-Investigator: Waimei A Tai, MD         
Sub-Investigator: Jean Marc Olivot, MD         
Sponsors and Collaborators
Stanford University
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Principal Investigator: Christine Wijman Stanford University
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Responsible Party: Stanford University Identifier: NCT00363662    
Other Study ID Numbers: 2R01NS034866-08A1 ( U.S. NIH Grant/Contract )
First Posted: August 15, 2006    Key Record Dates
Last Update Posted: June 13, 2012
Last Verified: June 2012
Additional relevant MeSH terms:
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Cerebral Hemorrhage
Pathologic Processes
Intracranial Hemorrhages
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases