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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
  Purpose

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


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

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Effect of Diffusion Weighted Imaging Abnormalities on Outcomes in Patients With Spontaneous Intracerebral Hemorrhage

Resource links provided by NLM:


Further study details as provided by Rush University Medical Center:

Primary Outcome Measures:
  • Modified Rankin Scale (mRS) [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 174
Study Start Date: September 2011
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts
Spontaneous Intracerebral Hemorrhage
Patients with primary intracerebral hemorrhage within 24 hours of admission diagnosed by non-contrast head computed tomography (CT)

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.

  Eligibility

Ages Eligible for Study:   19 Years to 79 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01417117

Contacts
Contact: Rajeev K Garg, MD 312-942-9850 rajeev_k_garg@rush.edu

Locations
United States, Illinois
Rush University Medical Center Recruiting
Chicago, Illinois, United States, 60612
Contact: Rajeev Garg, MD    312-942-4500      
Principal Investigator: Rajeev K Garg, MD         
Rush University Medical Center Recruiting
Chicago, Illinois, United States, 60612
Contact: Rajeev K Garg, MD    312-942-4500      
Principal Investigator: Rajeev K Garg, MD         
Sponsors and Collaborators
Rush University Medical Center
American Heart Association
Investigators
Principal Investigator: Rajeev K Garg, MD Rush University Medical Center Deparment of Neurological Sciences
  More Information

No publications provided

Responsible Party: Rajeev K Garg, Assistant Professor of Neurological Sciences and Neurosurgery, Rush University Medical Center
ClinicalTrials.gov Identifier: NCT01417117     History of Changes
Other Study ID Numbers: 11011402
Study First Received: August 12, 2011
Last Updated: November 6, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Rush University Medical Center:
Intracerebral Hemorrhage
Ischemic Stroke
Diffusion Weight Imaging Abnormalities
Neurologic Outcome

Additional relevant MeSH terms:
Body Weight
Cerebral Hemorrhage
Cerebral Infarction
Hemorrhage
Ischemia
Stroke
Brain Diseases
Brain Infarction
Brain Ischemia
Cardiovascular Diseases
Central Nervous System Diseases
Cerebrovascular Disorders
Intracranial Hemorrhages
Nervous System Diseases
Pathologic Processes
Signs and Symptoms
Vascular Diseases

ClinicalTrials.gov processed this record on November 27, 2014