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Effect of Ischemic Strokes on Recovery From Intracerebral Hemorrhages

NCT ID: NCT01417117

Last Updated: 2017-10-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

130 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-09-30

Study Completion Date

2017-06-30

Brief Summary

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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

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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.

Conditions

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Hemorrhage; Intracerebral, Nontraumatic Ischemic Strokes Diffusion Weighted Imaging Lesions

Keywords

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Intracerebral Hemorrhage Ischemic Stroke Diffusion Weight Imaging Abnormalities Neurologic Outcome

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Spontaneous Intracerebral Hemorrhage

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

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

19 Years

Maximum Eligible Age

79 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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American Heart Association

OTHER

Sponsor Role collaborator

Rush University

OTHER

Sponsor Role collaborator

Rush University Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Rajeev K Garg

Assistant Professor of Neurological Sciences and Neurosurgery

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Rajeev K Garg, MD

Role: PRINCIPAL_INVESTIGATOR

Rush University Medical Center Deparment of Neurological Sciences

Locations

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Rush University Medical Center

Chicago, Illinois, United States

Site Status

Countries

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United States

Other Identifiers

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11011402

Identifier Type: -

Identifier Source: org_study_id