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Effect of Ischemic Strokes on Recovery From Intracerebral Hemorrhages

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Status

Completed

Conditions

Diffusion Weighted Imaging Lesions
Hemorrhage; Intracerebral, Nontraumatic
Ischemic Strokes

Study type

Observational

Funder types

Other

Identifiers

NCT01417117
11011402

Details and patient eligibility

About

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

Full 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.

Enrollment

130 estimated patients

Sex

All

Ages

19 to 79 years old

Volunteers

No Healthy Volunteers

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

Trial design

130 participants in 1 patient group

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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