Effect of Ischemic Strokes on Recovery From Intracerebral Hemorrhages

Ischemic Strokes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01417117
• Other study ID #: 11011402
• Status: Completed
• Phase: N/A
• First received: August 12, 2011
• Last updated: October 18, 2017
• Start date: September 2011
• Est. completion date: June 2017

Study information

• Verified date: October 2017
• Source: Rush University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 130
• Est. completion date: June 2017
• Est. primary completion date: June 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 79 Years

Eligibility

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

Related Conditions & MeSH terms

• Body Weight
• Cerebral Hemorrhage
• Cerebral Infarction
• Diffusion Weighted Imaging Lesions
• Hemorrhage
• Hemorrhage; Intracerebral, Nontraumatic
• Ischemia
• Ischemic Strokes
• Stroke

Locations

Country	Name	City	State
United States	Rush University Medical Center	Chicago	Illinois

Sponsors (3)

Lead Sponsor	Collaborator
Rush University Medical Center	American Heart Association, Rush University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Modified Rankin Scale (mRS)	Modified Rankin Scale (mRS)	3 months
Secondary	National Institutes of Health Stroke Scale	National Institutes of Health Stroke Scale	14 days or discharge
Secondary	Modified Rankin Scale (mRS)	Modified Rankin Scale (mRS)	14 days
Secondary	Modified Rankin Scale (mRS)	Modified Rankin Scale (mRS)	6 months