Effect of Ischemic Strokes on Recovery From Intracerebral Hemorrhages

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

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

Study Overview

• Status: Completed
• Conditions: 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.

• Study Type: Observational
• Enrollment (Anticipated): 130

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60612
      • Rush University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 79 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Modified Rankin Scale (mRS)	Modified Rankin Scale (mRS)	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
National Institutes of Health Stroke Scale	National Institutes of Health Stroke Scale	14 days or discharge
Modified Rankin Scale (mRS)	Modified Rankin Scale (mRS)	14 days
Modified Rankin Scale (mRS)	Modified Rankin Scale (mRS)	6 months

Collaborators and Investigators

• Sponsor: Rush University Medical Center
• Collaborators: American Heart Association; Rush University
• Investigators: Principal Investigator: Rajeev K Garg, MD, Rush University Medical Center Deparment of Neurological Sciences

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2011
• Primary Completion (Actual): June 1, 2017
• Study Completion (Actual): June 1, 2017

Study Registration Dates

• First Submitted: August 12, 2011
• First Submitted That Met QC Criteria: August 15, 2011
• First Posted (Estimate): August 16, 2011

Study Record Updates

• Last Update Posted (Actual): October 20, 2017
• Last Update Submitted That Met QC Criteria: October 18, 2017
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Keywords: Ischemic Stroke; Intracerebral Hemorrhage; Diffusion Weight Imaging Abnormalities; Neurologic Outcome
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Intracranial Hemorrhages; Stroke; Ischemic Stroke; Ischemia; Hemorrhage; Body Weight; Cerebral Hemorrhage
• Other Study ID Numbers: 11011402

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No