Effect of Ischemic Strokes on Recovery From Intracerebral Hemorrhages

The Effect of Diffusion Weighted Imaging Abnormalities on Outcomes in Patients With Spontaneous Intracerebral Hemorrhage

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01417117

Enrollment

130

Registered

2011-08-16

Start date

2011-09-30

Completion date

2017-06-30

Last updated

2017-10-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diffusion Weighted Imaging Lesions, Hemorrhage; Intracerebral, Nontraumatic, Ischemic Strokes

Keywords

Intracerebral Hemorrhage, Ischemic Stroke, Diffusion Weight Imaging Abnormalities, Neurologic Outcome

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

19 Years to 79 Years

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

Design outcomes

Primary

Measure	Time frame	Description
Modified Rankin Scale (mRS)	3 months	Modified Rankin Scale (mRS)

Secondary

Measure	Time frame	Description
National Institutes of Health Stroke Scale	14 days or discharge	National Institutes of Health Stroke Scale
Modified Rankin Scale (mRS)	14 days	Modified Rankin Scale (mRS)

Countries

United States

Outcome results