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Effect of Ischemic Strokes on Recovery From Intracerebral Hemorrhages

This study is currently recruiting participants.
Verified April 2017 by Rajeev K Garg, Rush University Medical Center
Sponsor:
ClinicalTrials.gov Identifier:
NCT01417117
First Posted: August 16, 2011
Last Update Posted: April 25, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborators:
American Heart Association
Rush University
Information provided by (Responsible Party):
Rajeev K Garg, Rush University Medical Center
August 12, 2011
August 16, 2011
April 25, 2017
September 2011
June 2017   (Final data collection date for primary outcome measure)
Modified Rankin Scale (mRS) [ Time Frame: 3 months ]
Modified Rankin Scale (mRS)
Modified Rankin Scale (mRS) [ Time Frame: 3 months ]
Complete list of historical versions of study NCT01417117 on ClinicalTrials.gov Archive Site
  • National Institutes of Health Stroke Scale [ Time Frame: 14 days or discharge ]
    National Institutes of Health Stroke Scale
  • Modified Rankin Scale (mRS) [ Time Frame: 14 days ]
    Modified Rankin Scale (mRS)
  • Modified Rankin Scale (mRS) [ Time Frame: 6 months ]
    Modified Rankin Scale (mRS)
  • National Institutes of Health Stroke Scale [ Time Frame: 14 days or discharge ]
  • Modified Rankin Scale (mRS) [ Time Frame: 14 days ]
  • Modified Rankin Scale (mRS) [ Time Frame: 6 months ]
Not Provided
Not Provided
 
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
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.
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample
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.
  • Hemorrhage; Intracerebral, Nontraumatic
  • Ischemic Strokes
  • Diffusion Weighted Imaging Lesions
Not Provided
Spontaneous Intracerebral Hemorrhage
Patients with primary intracerebral hemorrhage within 24 hours of admission diagnosed by non-contrast head computed tomography (CT)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
130
June 2018
June 2017   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
19 Years to 79 Years   (Adult, Senior)
No
Contact: Rajeev K Garg, MD 312-942-9850 rajeev_k_garg@rush.edu
United States
 
 
NCT01417117
11011402
No
Not Provided
Plan to Share IPD: No
Rajeev K Garg, Rush University Medical Center
Rush University Medical Center
  • American Heart Association
  • Rush University
Principal Investigator: Rajeev K Garg, MD Rush University Medical Center Deparment of Neurological Sciences
Rush University Medical Center
April 2017