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Cerebral HemorrhageDASHNCT00363662

Diagnostic Utility of MRI in Intracerebral Hemorrhage

An observational study of Cerebral Hemorrhage, run by Stanford University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Cerebral Hemorrhage
How many people
180 participants
Where
1 siteUnited States
Study dates
26 Jun 2006to 27 Jan 2010
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 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

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.

Who may be able to join

  • Men and non-pregnant women, at least 18 years of age.
  • Patients with an ICH or IVH admitted to Stanford University Medical center within 48 hours of symptom onset.
  • Ability to undergo MRI.

Who cannot join

  • Patients with a known (preexisting) source for ICH, for example a known untreated arterio-venous malformation.
  • Patients receiving investigational drug therapies or procedures prior to MRI scanning.
  • Glasgow coma scale (GCS) score < 6 in the absence of sedating medications.
  • Informed consent cannot be obtained either directly from the patient or from a legally authorized representative.
  • Severe coexisting or terminal systemic disease that limits life expectancy or that may interfere with the conduct of the study

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Stanford University School of Medicine

    Stanford, California, 94305

Other trials in United States

About this study

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.

Read the 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:
  2. MRI will more frequently yield a correct specific hemorrhage etiology than conventional non-contrast CT.
  3. MRI will increase the certainty of a specific hemorrhage etiology when compared to conventional non-contrast CT.
  4. MRI will affect management in patients who present with a spontaneous ICH or IVH diagnosed by CT.
  5. The yield of MRI in patients with a spontaneous ICH or IVH varies among diagnostic categories.
  6. Routine use of MRI in patients with spontaneous ICH or IVH will reduce the need for conventional (and invasive) cerebral angiography in these patients.
  7. 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:
  8. 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.
  9. 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:
  10. 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.

Medical subject headings
Cerebral Hemorrhage

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Diagnostic comparison

    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).

    Measured: Approximately 60 minutes to acquire each scan.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Aug 2006 (estimated)
  2. Study start26 Jun 2006
  3. Primary completion27 Jan 2010
  4. Study completion27 Jan 2010

Resources

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
180 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00363662
Sponsor's protocol ID
2R01NS034866-08A1
Acronym
DASH
Status last verified
Nov 2021
First submitted
9 Aug 2006
Last updated
17 Nov 2021
Results posted
No

Questions about this trial

What is this clinical trial studying?

An observational study of Cerebral Hemorrhage, run by Stanford University 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 3 inclusion and 5 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: finished, as of the sponsor's last update on 17 Nov 2021. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Diagnostic comparison (time frame: Approximately 60 minutes to acquire each scan.). 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 17 Nov 2021.

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