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Diagnostic Utility of MRI in Intracerebral Hemorrhage (DASH)

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.
 
ClinicalTrials.gov Identifier: NCT00363662
Recruitment Status : Completed
First Posted : August 15, 2006
Last Update Posted : November 17, 2021
Sponsor:
Information provided by (Responsible Party):
Marion S Buckwalter, 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
Actual Enrollment : 180 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Diagnostic Utility of MRI in Intracerebral Hemorrhage
Actual Study Start Date : June 26, 2006
Actual Primary Completion Date : January 27, 2010
Actual Study Completion Date : January 27, 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bleeding




Primary Outcome Measures :
  1. Diagnostic comparison [ Time Frame: Approximately 60 minutes to acquire each scan. ]
    Compare the diagnosis by the treating physician (based on the patient history, examination, CT, and angiography results) with the treating physician's diagnosis based on additional review of the MRI. The CT-based diagnosis and the MRI-based diagnosis by the treating physician will be compared to the "gold standard" diagnosis reached by the outside adjudication panel (which excludes information from the MRI studies).



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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.
Criteria

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 ClinicalTrials.gov identifier (NCT number): NCT00363662


Locations
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United States, California
Stanford University School of Medicine
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
Investigators
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Principal Investigator: Gregory Albers, MD Stanford University
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Responsible Party: Marion S Buckwalter, Principle Investigator, Stanford University
ClinicalTrials.gov Identifier: NCT00363662    
Other Study ID Numbers: 2R01NS034866-08A1 ( U.S. NIH Grant/Contract )
First Posted: August 15, 2006    Key Record Dates
Last Update Posted: November 17, 2021
Last Verified: November 2021
Additional relevant MeSH terms:
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Cerebral Hemorrhage
Hemorrhage
Pathologic Processes
Intracranial Hemorrhages
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases