Effect of Ischemic Strokes on Recovery From Intracerebral Hemorrhages

NCT01417117 | Completed

• 1 other identifier: 11011402
• Study Type: observational
• Target: 130
• Locations: 1 country
• Sites: 1

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

Conditions

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Modified Rankin Scale (mRS)

  Modified Rankin Scale (mRS)

  3 months

Secondary Outcomes (3)

• National Institutes of Health Stroke Scale

  14 days or discharge

• Modified Rankin Scale (mRS)

  14 days

• Modified Rankin Scale (mRS)

  6 months

Study Arms (1)

Spontaneous Intracerebral Hemorrhage

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

Eligibility Criteria

• Age: 19 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Rush University Medical Center: lead
• American Heart Association: collaborator
• Rush University: collaborator

Study Sites (1)

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

MeSH Terms

Conditions

Hemorrhage; Ischemic Stroke; Cerebral Hemorrhage

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Intracranial Hemorrhages

Study Officials

• Rajeev K Garg, MD

  Rush University Medical Center Deparment of Neurological Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Neurological Sciences and Neurosurgery

Study Record Dates

• First Submitted: August 12, 2011
• First Posted: August 16, 2011
• Study Start: September 1, 2011
• Primary Completion: June 1, 2017
• Study Completion: June 1, 2017
• Last Updated: October 20, 2017

Record last verified: 2017-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)