- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00962546
Computed Tomographic (CT) Perfusion and CT Angiography as Screening Tools for Vasospasm Following Subarachnoid Hemorrhage
December 8, 2014 updated by: Michelle Miller-Thomas, MD, Washington University School of Medicine
Computed Tomographic Perfusion and Computed Tomographic Angiography as Screening Tools for Vasospasm Following Subarachnoid Hemorrhage
Cerebral vasospasm is a devastating complication of subarachnoid hemorrhage after cerebral aneurysm rupture leading to cerebral ischemia and potentially cerebral infarction.
The current gold standard diagnostic imaging study for cerebral vasospasm is catheter cerebral angiography, an invasive diagnostic procedure carrying a complication rate of 1-2% per procedure.
Computed tomographic perfusion imaging (CTP) and computed tomographic angiography (CTA) are noninvasive diagnostic imaging studies frequently utilized in the evaluation of embolic and thrombotic cerebral infarct.
The investigators hypothesize that CTP and CTA may be utilized as screening tools for cerebral vasospasm following aneurysmal subarachnoid hemorrhage requiring treatment and provide prognostic information.
Study Overview
Status
Completed
Study Type
Observational
Enrollment (Actual)
4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Missouri
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St. Louis, Missouri, United States, 63110
- Barnes-Jewish Hospital
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Patients admitted to the neurological intensive care unit with subarachnoid hemorrhage due to rupture of a cerebral aneurysm
Description
Inclusion Criteria:
- subarachnoid hemorrhage after aneurysm rupture
Exclusion Criteria:
- renal insufficiency
- pregnancy
- contrast reaction
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
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CTA/CTP
Patients undergo CTA/CTP imaging prior to cerebral angiography
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
CT perfusion parameters
Time Frame: at time of catheter angiogram
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at time of catheter angiogram
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Disposition at discharge
Time Frame: At time of hospital discharge
|
At time of hospital discharge
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vessel narrowing by CT angiography
Time Frame: at time of catheter angiogram
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at time of catheter angiogram
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Michelle Miller-Thomas, MD, Washington University School of Medicine
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Wintermark M, Ko NU, Smith WS, Liu S, Higashida RT, Dillon WP. Vasospasm after subarachnoid hemorrhage: utility of perfusion CT and CT angiography on diagnosis and management. AJNR Am J Neuroradiol. 2006 Jan;27(1):26-34.
- Aralasmak A, Akyuz M, Ozkaynak C, Sindel T, Tuncer R. CT angiography and perfusion imaging in patients with subarachnoid hemorrhage: correlation of vasospasm to perfusion abnormality. Neuroradiology. 2009 Feb;51(2):85-93. doi: 10.1007/s00234-008-0466-7. Epub 2008 Oct 11.
- Mustonen T, Koivisto T, Vanninen R, Hanninen T, Vapalahti M, Hernesniemi J, Kuikka JT, Vanninen E. Heterogeneity of cerebral perfusion 1 week after haemorrhage is an independent predictor of clinical outcome in patients with aneurysmal subarachnoid haemorrhage. J Neurol Neurosurg Psychiatry. 2008 Oct;79(10):1128-33. doi: 10.1136/jnnp.2007.142851. Epub 2008 Mar 20.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2009
Primary Completion (Actual)
December 1, 2011
Study Completion (Actual)
December 1, 2011
Study Registration Dates
First Submitted
August 19, 2009
First Submitted That Met QC Criteria
August 19, 2009
First Posted (Estimate)
August 20, 2009
Study Record Updates
Last Update Posted (Estimate)
December 9, 2014
Last Update Submitted That Met QC Criteria
December 8, 2014
Last Verified
December 1, 2014
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pathologic Processes
- Cardiovascular Diseases
- Vascular Diseases
- Cerebrovascular Disorders
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Intracranial Arterial Diseases
- Intracranial Hemorrhages
- Hemorrhage
- Aneurysm
- Subarachnoid Hemorrhage
- Vasospasm, Intracranial
- Intracranial Aneurysm
Other Study ID Numbers
- HRPO 09-0950
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.