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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

Tracking Information
First Submitted Date August 9, 2006
First Posted Date August 15, 2006
Last Update Posted Date November 17, 2021
Actual Study Start Date June 26, 2006
Actual Primary Completion Date January 27, 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: November 9, 2021)
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).
Original Primary Outcome Measures Not Provided
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Diagnostic Utility of MRI in Intracerebral Hemorrhage
Official Title Diagnostic Utility of MRI in Intracerebral Hemorrhage
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.
Detailed Description

Spontaneous intracerebral hemorrhage (ICH) and intraventricular hemorrhage (IVH) account for at least 15% of strokes worldwide. There are many possible etiologies for spontaneous (i.e. non-traumatic) ICH or IVH such as longstanding hypertension and cerebral amyloid angiopathy.

Other causes include vascular malformations, intracranial aneurysms, tumors, coagulopathies, use of thrombolytic or antithrombotic drugs, cerebral venous thrombosis, hemorrhagic transformation of an ischemic infarct, illicit drug use, endocarditis, and vasculitis.

Identification of the cause of an ICH or IVH typically relies on clinical evaluation supported by computer tomography (CT) with or without conventional contrast cerebral angiography in selected patients. While magnetic resonance imaging (MRI) has substantially improved our diagnostic capabilities, the appropriate use of MRI and its effectiveness has not been studied systematically in these patients. Furthermore, it is unclear whether routine MRI in ICH yields clinically relevant data. For this reason routine use or MRI in patients with ICH is highly variable in clinical practice. Furthermore, it is unclear whether the findings detected on MRI will change management decisions regarding further diagnostic testing and therapeutic options above and beyond that which can be achieved by CT and cerebral angiography.

This question has major ramifications for the care of patients with ICH or IVH. If MRI truly can categorize patients into specific diagnostic categories better than CT, this would represent a major paradigm shift in the way that these patients are typically evaluated. On the other hand, because of the added expense of MRI, its general use could result in a substantial increase in the cost of neurological care. These added costs must result in improvements in patient management in order to justify the added financial resources involved.

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. During this 5-year study, 160 consecutive inpatients presenting with a spontaneous ICH or IVH within 48 hours of symptom onset will be prospectively categorized into specific hemorrhage subtypes based upon the findings on MRI. We will:

  1. Prospectively assess the value of early MRI in determining hemorrhage etiology in consecutive patients who present with a spontaneous ICH or IVH diagnosed by CT. We will test the hypotheses that:

    1. MRI will more frequently yield a correct specific hemorrhage etiology than conventional non-contrast CT.
    2. MRI will increase the certainty of a specific hemorrhage etiology when compared to conventional non-contrast CT.
    3. MRI will affect management in patients who present with a spontaneous ICH or IVH diagnosed by CT.
    4. The yield of MRI in patients with a spontaneous ICH or IVH varies among diagnostic categories.
    5. Routine use of MRI in patients with spontaneous ICH or IVH will reduce the need for conventional (and invasive) cerebral angiography in these patients.
  2. Prospectively assess the relative added value of an improved MR protocol (MRA/MRV, GRE, DWI, TEDS, PROPELLER) in the evaluation and management of patients with ICH or IVH determined by non-contrast CT.

    We will test the hypotheses that:

    a. MRI with multi-echo, multi-shot GRE sequences, MRA, MR venography (MRV), SENSE-DWI and PROPELLER-DWI will more accurately assign patients into appropriate diagnostic categories than conventional MRI (T1W, T1W post gadolinium, T2W [FSE/FLAIR FSE]) and CT.

  3. Prospectively identify the added benefit of repeated MRI in the chronic stage in the evaluation and management of patients with ICH or IVH. We will test the hypotheses that:

    1. Repeat MRI in the chronic stage (at 60 days) will yield a specific ICH etiology above and beyond early MRI and CT.

This information will contribute substantially to our understanding of the value of routine MRI in patients with a spontaneous ICH or IVH both in the acute and in the chronic phase. It will also allow us to develop practice guidelines for the use of MRI in these patients.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition Cerebral Hemorrhage
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: November 9, 2021)
180
Original Enrollment
 (submitted: August 9, 2006)
160
Actual Study Completion Date January 27, 2010
Actual Primary Completion Date January 27, 2010   (Final data collection date for primary outcome measure)
Eligibility 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

Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT00363662
Other Study ID Numbers 2R01NS034866-08A1( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Marion S Buckwalter, Stanford University
Study Sponsor Stanford University
Collaborators Not Provided
Investigators
Principal Investigator: Gregory Albers, MD Stanford University
PRS Account Stanford University
Verification Date November 2021