Northern Neurosciences, Inc.
Diagnostic Imaging in Stroke Patients
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BACKGROUND: MRI has become a common means of evaluating stroke patients based predominantly on reports that suggest MRI is more likely than CT to demonstrate ischemic infarction in the acute setting (i.e., within the first several hours from stroke onset). However, it is not clear that using MRI instead of CT either (1) improves patient management and results in better clinical outcomes or (2) provides diagnostic information in a cost-effective manner. The chief concern is the value of the information that the MRI provides about the stroke patient. Although MRI has been found to produce more information about the patient, it has not been demonstrated whether or not such information is necessary or even appropriate to direct the patient’s clinical management. Another concern about the utility of MRI is that most stroke patients are not evaluated with MRI acutely after suffering a stroke simply because it takes too long to actually obtain the study. Furthermore, even assuming that the extra information provided by an acute MRI study does change the patient’s clinical management in an appropriate manner, it is not clear that any improvement in clinical outcome would offset the extra cost of the MRI study. It may be, then, that the use of MRI in the evaluation of ischemic stroke patients does not significantly impact their clinical management in comparison with CT-based neuroimaging protocols.
HYPOTHESIS: We hypothesize that stroke patients who are evaluated with a single MRI study during their hospitalization will have equivalent 6 month clinical outcomes and greater total healthcare expenditures than will stroke patients who are evaluated with serial CT studies.
METHODS: All patients admitted to the emergency room and diagnosed with ischemic stroke or a transient ischemic attack (TIA) will be eligible for enrollment. Following the initial CT scan in the emergency room, patients will be randomized into one of two treatment groups. The first group of patients will be routinely evaluated with MRI (i.e., as soon as allowed by scheduling) during their hospitalization. The second group of patients will be evaluated with a repeat CT scan to be performed shortly before the patient’s discharge from the hospital (i.e., typically 2-3d after admission). After enrollment in the study the patients will be admitted to the neurology stroke service under the care of a fellowship-trained stroke neurologist. All patients in the study will be evaluated with other diagnostic tests and administered treatments at the discretion of the admitting stroke neurologist. Follow-up outpatient clinic evaluations will be required 6 months after discharge from the stroke service
