Effect of Ischemic Strokes on Recovery From Intracerebral Hemorrhages

Completed

• Conditions: Hemorrhage; Intracerebral, Nontraumatic; Diffusion Weighted Imaging Lesions; Ischemic Strokes

• Registration Number: NCT01417117
• Lead Sponsor: 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

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.

Study Timeline

• Study First Submitted: 2011-08-12
• Study First Submitted QC: 2011-08-15
• Study First Posted: 2011-08-16
• Study Start: 2011-09
• Primary Completion: 2017-06
• Study Completion: 2017-06
• Status Verified: 2017-10
• Last Update Submitted: 2017-10-18
• Last Update Posted: 2017-10-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 130

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Modified Rankin Scale (mRS)	3 months	Modified Rankin Scale (mRS)

Secondary Outcome Measures

Name	Time	Method
Modified Rankin Scale (mRS)	6 months	Modified Rankin Scale (mRS)
National Institutes of Health Stroke Scale	14 days or discharge	National Institutes of Health Stroke Scale

Trial Locations

Locations (1)

Rush University Medical Center; 🇺🇸 Chicago, Illinois, United States