Effect of Ischemic Strokes on Recovery From Intracerebral Hemorrhages

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2014 by Rush University Medical Center
Sponsor:
Collaborator:
American Heart Association
Information provided by (Responsible Party):
Rajeev K Garg, Rush University Medical Center
ClinicalTrials.gov Identifier:
NCT01417117
First received: August 12, 2011
Last updated: November 6, 2014
Last verified: November 2014

August 12, 2011
November 6, 2014
September 2011
December 2016   (final data collection date for primary outcome measure)
Modified Rankin Scale (mRS) [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Same as current
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 ] [ Designated as safety issue: No ]
  • Modified Rankin Scale (mRS) [ Time Frame: 14 days ] [ Designated as safety issue: No ]
  • Modified Rankin Scale (mRS) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Same as current
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
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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
174
December 2016
December 2016   (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
  • GCS 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 hypercapenic respiratory failure
  • History of deep venous thrombosis
  • Contraindications to MRI based upon institutional safety checklist
Both
19 Years to 79 Years
No
Contact: Rajeev K Garg, MD 312-942-9850 rajeev_k_garg@rush.edu
United States
 
NCT01417117
11011402
No
Rajeev K Garg, Rush University Medical Center
Rush University Medical Center
American Heart Association
Principal Investigator: Rajeev K Garg, MD Rush University Medical Center Deparment of Neurological Sciences
Rush University Medical Center
November 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP