Clinical trial NCT01417117: Effect of Ischemic Strokes on Recovery From Intracerebral Hemorrhages
Official title: The Effect of Diffusion Weighted Imaging Abnormalities on Outcomes in Patients With Spontaneous Intracerebral Hemorrhage
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hemorrhage; Intracerebral, Nontraumatic
Ischemic Strokes
Diffusion Weighted Imaging Lesions
Keywords: Intracerebral Hemorrhage
Ischemic Stroke
Diffusion Weight Imaging Abnormalities
Neurologic Outcome
Lead sponsor: Rush University Medical Center
Sponsor class: OTHER
Collaborators: name: American Heart Association
name: Rush University
First posted: 2011-08-16
Enrollment: 130
Sex: ALL
Minimum age (years): 19
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects for this study will be selected from patients admitted with a primary intracerebral hemorrhage to Rush University Medical Center's Neurosciences Intensive Care Unit.

Brief summary: Intracerebral hemorrhage (ICH) occurs when small arteries in the brain rupture due to weakening by age, high blood pressure, and/or elevated cholesterol. In addition to artery rupture, recent data suggests that patients with ICH are also at risk for developing occlusion of arteries during the acute phase, called ischemic strokes. Data suggests these ischemic strokes can negatively impact patient outcomes. Diffusion weighted imaging (DWI) is a sequence on Magnetic Resonance Imaging (MRI) that is a sensitive marker for ischemic strokes in the brain. In this proposal, our primary aim is examine prospectively the effect DWI abnormalities have on functional outcomes in patients with ICH. Our hypothesis is that the DWI abnormalities found on MRI of the brain lead to worse functional outcomes in patients with ICH

Detailed description: Diffusion weighted imaging (DWI) is a sensitive method to assess for secondary ischemia in patients with acute brain injury. By comparing the outcomes of patients with and without DWI abnormalities, we would able to assess the impact these lesions have on functional recovery in patients with ICH. Since no direct therapies exist for this disease, DWI abnormalities may be a novel target for intervention to improve outcomes. If traditionally assessed functional outcomes are not affected by DWI, the mechanism behind these lesions would still warrant further evaluation and potential treatment. Detection of subclinical infarcts has emerged as a potential surrogate marker for subsequent risk of stroke, vascular dementia, and cognitive impairment. Furthermore, the cause behind DWI lesions in acute ICH may lead to better understanding the pathophysiologic interplay between ischemic and hemorrhagic strokes.

Eligibility criteria: Inclusion Criteria:

* Patients \> 18 years and \< 80 years
* Spontaneous intracerebral hemorrhage documented by CT scan
* Less than 24 hours from time last seen normal to first medical evaluation
* No prior clinical history of stroke (i.e. subarachnoid hemorrhage, ICH, or ischemic strokes)

Exclusion Criteria:

* Pregnancy
* History of cancer
* Pre-admission mRS \> 2
* Glasgow Coma Scale less than 5
* ICH secondary to aneurysm, vascular malformation, mycotic aneurysm, primary or metastatic tumor, trauma, warfarin-related ICH, acute-fibrinolytic associated ICH, or coagulopathy
* Associated epidural or subdural hematoma
* Surgical intervention \< 48 hours from admission
* Hemodynamic instability (need for vasopressor therapy)
* Acute hypoxemic or hypercapnic respiratory failure
* History of deep venous thrombosis
* Contraindications to MRI based upon institutional safety checklist

Primary outcomes:
measure: Modified Rankin Scale (mRS)
timeFrame: 3 months
Secondary outcomes:
measure: National Institutes of Health Stroke Scale
timeFrame: 14 days or discharge
measure: Modified Rankin Scale (mRS)
timeFrame: 14 days
measure: Modified Rankin Scale (mRS)
timeFrame: 6 months
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
Study officials:
affiliation: Rush University Medical Center Deparment of Neurological Sciences
name: Rajeev K Garg, MD
role: PRINCIPAL_INVESTIGATOR
References: