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Effect of Ischemic Strokes on Recovery From Intracerebral Hemorrhages

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01417117
Recruitment Status : Completed
First Posted : August 16, 2011
Last Update Posted : October 20, 2017
American Heart Association
Rush University
Information provided by (Responsible Party):
Rajeev K Garg, Rush University Medical Center

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

Condition or disease
Hemorrhage; Intracerebral, Nontraumatic Ischemic Strokes Diffusion Weighted Imaging Lesions

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.

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Study Type : Observational
Estimated Enrollment : 130 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Effect of Diffusion Weighted Imaging Abnormalities on Outcomes in Patients With Spontaneous Intracerebral Hemorrhage
Actual Study Start Date : September 2011
Actual Primary Completion Date : June 2017
Actual Study Completion Date : June 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bleeding

Spontaneous Intracerebral Hemorrhage
Patients with primary intracerebral hemorrhage within 24 hours of admission diagnosed by non-contrast head computed tomography (CT)

Primary Outcome Measures :
  1. Modified Rankin Scale (mRS) [ Time Frame: 3 months ]
    Modified Rankin Scale (mRS)

Secondary Outcome Measures :
  1. National Institutes of Health Stroke Scale [ Time Frame: 14 days or discharge ]
    National Institutes of Health Stroke Scale

  2. Modified Rankin Scale (mRS) [ Time Frame: 14 days ]
    Modified Rankin Scale (mRS)

  3. Modified Rankin Scale (mRS) [ Time Frame: 6 months ]
    Modified Rankin Scale (mRS)

Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years to 79 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01417117

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United States, Illinois
Rush University Medical Center
Chicago, Illinois, United States, 60612
Sponsors and Collaborators
Rush University Medical Center
American Heart Association
Rush University
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Principal Investigator: Rajeev K Garg, MD Rush University Medical Center Deparment of Neurological Sciences
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Responsible Party: Rajeev K Garg, Assistant Professor of Neurological Sciences and Neurosurgery, Rush University Medical Center Identifier: NCT01417117    
Other Study ID Numbers: 11011402
First Posted: August 16, 2011    Key Record Dates
Last Update Posted: October 20, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Rajeev K Garg, Rush University Medical Center:
Intracerebral Hemorrhage
Ischemic Stroke
Diffusion Weight Imaging Abnormalities
Neurologic Outcome
Additional relevant MeSH terms:
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Cerebral Hemorrhage
Body Weight
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Pathologic Processes
Intracranial Hemorrhages