Effect of Ischemic Strokes on Recovery From Intracerebral Hemorrhages
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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 |
- Modified Rankin Scale (mRS) [ Time Frame: 3 months ] [ Designated as safety issue: No ]
- 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 2013 |
| Estimated Primary Completion Date: | December 2013 (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 |
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.
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| Contact: Rajeev K Garg, MD | 312-942-9850 | rajeev_k_garg@rush.edu |
| 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 | |
| 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: | August 9, 2012 |
| 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 May 19, 2013