Hemorrhage; Intracerebral, NontraumaticNCT01417117
Effect of Ischemic Strokes on Recovery From Intracerebral Hemorrhages
An observational study of Hemorrhage; Intracerebral, Nontraumatic and Ischemic Strokes, run by Rush University Medical Center at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 19 to 79 years
- Conditions the study is for
- Hemorrhage; Intracerebral, Nontraumatic, Ischemic Strokes, Diffusion Weighted Imaging Lesions
- How many people
- 130 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2011to Jun 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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)
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Rush University Medical Center
Chicago, Illinois, 60612
About this study
Official title: 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
Read the 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.
- Conditions
- Hemorrhage; Intracerebral, Nontraumatic, Ischemic Strokes, Diffusion Weighted Imaging Lesions
- Keywords
- Intracerebral Hemorrhage, Ischemic Stroke, Diffusion Weight Imaging Abnormalities, Neurologic Outcome
- Medical subject headings
- Hemorrhage, Ischemic Stroke, Cerebral Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Spontaneous Intracerebral Hemorrhage | Patients with primary intracerebral hemorrhage within 24 hours of admission diagnosed by non-contrast head computed tomography (CT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Modified Rankin Scale (mRS)
Modified Rankin Scale (mRS)
Measured: 3 months
Secondary outcomes (3)
National Institutes of Health Stroke Scale
National Institutes of Health Stroke Scale
Measured: 14 days or discharge
Modified Rankin Scale (mRS)
Modified Rankin Scale (mRS)
Measured: 14 days
Modified Rankin Scale (mRS)
Modified Rankin Scale (mRS)
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2011 (estimated)
- Study startSep 2011
- Primary completionJun 2017
- Study completionJun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hemorrhage; Intracerebral, NontraumaticStudies of the same condition, open and under way.
- More trials run by Rush University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rush University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- American Heart Association, Rush University
- Responsible party
- Principal investigator, Rajeev K Garg, Rush University Medical Center
- Investigators
- Rajeev K Garg, MD, Principal investigator, Rush University Medical Center Deparment of Neurological Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01417117
- Sponsor's protocol ID
- 11011402
- Status last verified
- Oct 2017
- First submitted
- 12 Aug 2011
- Last updated
- 20 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Diffusion Weighted Imaging Abnormalities on Outcomes in Patients With Spontaneous Intracerebral Hemorrhage
- ClinicalTrials.gov ID
- NCT01417117
- Acronym / sponsor ID
- 11011402
- Conditions
- Hemorrhage; Intracerebral, Nontraumatic, Ischemic Strokes, Diffusion Weighted Imaging Lesions
- Keywords
- Intracerebral Hemorrhage, Ischemic Stroke, Diffusion Weight Imaging Abnormalities, Neurologic Outcome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- Rush University Medical CenterUniversity, hospital or other
- Collaborators
- American Heart Association, Rush University
- Study start
- Sep 2011 (actual)
- Primary completion
- Jun 2017 (actual)
- Study completion
- Jun 2017 (actual)
- First posted
- 16 Aug 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Spontaneous Intracerebral Hemorrhage | – | –Patients with primary intracerebral hemorrhage within 24 hours of admission diagnosed by non-contrast head computed tomography (CT) |
Who may qualify
- Ages
- 19 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Modified Rankin Scale (mRS)
Time frame: 3 months
Modified Rankin Scale (mRS)
3 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rajeev K Garg, MD principal investigator
Rush University Medical Center Deparment of Neurological Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hemorrhage; Intracerebral, Nontraumatic and Ischemic Strokes, run by Rush University Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Modified Rankin Scale (mRS) (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2017.