Effect of Ischemic Strokes on Recovery From Intracerebral Hemorrhages

This study is currently recruiting participants.
Verified June 2013 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: June 1, 2013
Last verified: June 2013
  Purpose

Intracerebral hemorrhage (ICH) is a type of stroke that leads to bleeding in the brain. It accounts for about 10-15% of all strokes in the United States. ICH has the highest risk of death among stroke types. Despite advances in medicine, the number of patients that survive after an ICH has not changed in the past 20 years. Furthermore, current treatments to limit bleeding in the brain have not led to improvement in patient recovery. Thus, no proven therapy exists for patients with ICH.

Over the course of one's life, risk factors such elevated blood pressure and cholesterol can weaken the small arteries of the brain leading them to rupture and cause an intracerebral hemorrhage (ICH). These same risk factors can also cause these arteries to narrow and occlude leading to another type of stroke called an ischemic stroke. Recent data suggest that certain patients with ICH can also develop ischemic strokes. In this study, we will use magnetic resonance imaging (MRI) to examine the occurrence of ischemic strokes in ICH patients. The purpose is to see whether the presence of ischemic strokes affects an ICH patient's ability to recover neurologically. Our hypothesis is that the presence of ischemic strokes can worsen the outcome of patients with ICH. Furthermore, we hope to use our data to raise new questions as to why ischemic strokes occur only in some patients with ICH.

If ischemic strokes are found to worsen the chance for neurologic recovery, they may provide a new treatment target in patients with ICH. Using our data, we plan to define potential causes for these ischemic strokes. We hope this will lead to a new study testing treatments that may prevent ischemic strokes and improve recovery in ICH patients. This would be a major shift in the care of patients with ICH. Besides limiting bleeding in the brain, prevention of other types of brain injury such as ischemic strokes may be important in improving outcomes.


Condition
Spontaneous Intracerebral Hemorrhage
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 2014
Estimated Primary Completion Date: December 2014 (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)

  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
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: June 1, 2013
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
Hemorrhage
Ischemia
Stroke
Cerebral Infarction
Cerebral Hemorrhage
Signs and Symptoms
Pathologic Processes
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Brain Infarction
Brain Ischemia
Intracranial Hemorrhages

ClinicalTrials.gov processed this record on April 22, 2014