Ignite Creation Date:
2024-05-05 @ 5:00 PM
Last Modification Date:
2024-10-26 @ 9:26 AM
Study NCT ID:
NCT00363662
Status:
COMPLETED
Last Update Posted:
2021-11-17
First Post:
2006-08-09
Brief Title:
Diagnostic Utility of MRI in Intracerebral Hemorrhage
Sponsor:
Stanford University
Organization:
Stanford University
Study Overview
Official Title:
Diagnostic Utility of MRI in Intracerebral Hemorrhage
Status:
COMPLETED
Status Verified Date:
2021-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
DASH
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 ie 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 MRAMRV 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 FSEFLAIR 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
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 MRAMRV 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 FSEFLAIR 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None