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.
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
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:
- 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:
- MRI will more frequently yield a correct specific hemorrhage etiology than conventional non-contrast CT.
- MRI will increase the certainty of a specific hemorrhage etiology when compared to conventional non-contrast CT.
- MRI will affect management in patients who present with a spontaneous ICH or IVH diagnosed by CT.
- The yield of MRI in patients with a spontaneous ICH or IVH varies among diagnostic categories.
- Routine use of MRI in patients with spontaneous ICH or IVH will reduce the need for conventional (and invasive) cerebral angiography in these patients.
- 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:
- 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.
- 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:
- 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.
- Conditions
- Cerebral Hemorrhage
- Medical subject headings
- Cerebral Hemorrhage
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
- First posted15 Aug 2006 (estimated)
- Study start26 Jun 2006
- Primary completion27 Jan 2010
- Study completion27 Jan 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral HemorrhageStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe 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
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marion S Buckwalter, Stanford University
- Investigators
- Gregory Albers, MD, Principal investigator, Stanford University
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
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic Utility of MRI in Intracerebral Hemorrhage
- ClinicalTrials.gov ID
- NCT00363662
- Acronym / sponsor ID
- DASH / 2R01NS034866-08A1
- Conditions
- Cerebral Hemorrhage
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- 26 Jun 2006 (actual)
- Primary completion
- 27 Jan 2010 (actual)
- Study completion
- 27 Jan 2010 (actual)
- First posted
- 15 Aug 2006 (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 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:
- 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:
- MRI will more frequently yield a correct specific hemorrhage etiology than conventional non-contrast CT.
- MRI will increase the certainty of a specific hemorrhage etiology when compared to conventional non-contrast CT.
- MRI will affect management in patients who present with a spontaneous ICH or IVH diagnosed by CT.
- The yield of MRI in patients with a spontaneous ICH or IVH varies among diagnostic categories.
- Routine use of MRI in patients with spontaneous ICH or IVH will reduce the need for conventional (and invasive) cerebral angiography in these patients.
- 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:
- 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.
- 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:
- 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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (5 listed)
- 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
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
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2021.
Related trials for Cerebral Hemorrhage
Not yet recruiting
BrainGate2: Feasibility Study of an Intracortical Neural Interface System for Persons With Aphasia (BG-Aphasia-01)
Expressive Aphasia, Aphasia Following Cerebral Infarction
Not yet recruitingPhase 3
TicAgreLor Versus Placebo to Prevent Cerebral ISCHemia in anEuRysmal Low Grade SAH A Double Blinded Randomised Controlled Study
Subarachnoid Hemorrhage, Aneurysmal, Brain Ischemia
Recruiting
Early Motor-Cognitive Integrative Training on Cognitive and Motor Performance in Patients With Aneurysmal Subarachnoid Hemorrhage
Subarachnoid Aneurysm Hemorrhage
RecruitingObservational study
Determining the Clinical Impact and Prevalence of Hemorrhagic Subtypes in Perimesencephalic Subarachnoid Hemorrhage
Subarachnoid Hemorrhage, Spontaneous, Subarachnoid Hemorrhage, Aneurysmal
RecruitingObservational study
Effect of Different Intravenous Fluids on Post-operative Chronic Subdural Hematoma Size and Recurrence
Chronic Subdural Hematoma
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.
Gregory Albers, MD principal investigator
Stanford University
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 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.