Computed Tomographic (CT) Perfusion and CT Angiography as Screening Tools for Vasospasm Following Subarachnoid Hemorrhage

The recruitment status of this study is unknown because the information has not been verified recently.

Verified March 2011 by Washington University School of Medicine.
Recruitment status was Recruiting

Sponsor:

Information provided by:

Washington University School of Medicine

ClinicalTrials.gov Identifier:

NCT00962546

First received: August 19, 2009

Last updated: March 2, 2011

Last verified: March 2011

History of Changes

Purpose

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.

Condition
Cerebral Vasospasm Cerebral Aneurysm Subarachnoid Hemorrhage

Study Type:	Observational
Study Design:	Observational Model: Cohort Time Perspective: Prospective
Official Title:	Computed Tomographic Perfusion and Computed Tomographic Angiography as Screening Tools for Vasospasm Following Subarachnoid Hemorrhage

Resource links provided by NLM:

MedlinePlus related topics: Aneurysms

U.S. FDA Resources

Further study details as provided by Washington University School of Medicine:

Primary Outcome Measures:

CT perfusion parameters [ Time Frame: at time of catheter angiogram ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Disposition at discharge [ Time Frame: At time of hospital discharge ] [ Designated as safety issue: No ]
vessel narrowing by CT angiography [ Time Frame: at time of catheter angiogram ] [ Designated as safety issue: No ]

Estimated Enrollment:	30
Study Start Date:	September 2009
Estimated Study Completion Date:	December 2011
Estimated Primary Completion Date:	September 2011 (Final data collection date for primary outcome measure)

Groups/Cohorts
CTA/CTP Patients undergo CTA/CTP imaging prior to cerebral angiography

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
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

Criteria

Inclusion Criteria:

subarachnoid hemorrhage after aneurysm rupture

Exclusion Criteria:

renal insufficiency
pregnancy
contrast reaction

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00962546

Contacts

Contact: Michelle Miller-Thomas, MD

314-362-5949

thomasm@mir.wustl.edu

Locations

United States, Missouri
Barnes-Jewish Hospital	Recruiting
St. Louis, Missouri, United States, 63110
Contact: Michelle Miller-Thomas, MD 314-362-5949 thomasm@mir.wustl.edu
Principal Investigator: Michelle Miller-Thomas, MD

Sponsors and Collaborators

Washington University School of Medicine

Investigators

Principal Investigator:

Michelle Miller-Thomas, MD

Washington University School of Medicine

More Information

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. Epub 2008 Oct 11.

Mustonen T, Koivisto T, Vanninen R, Hänninen 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. Epub 2008 Mar 20.

Responsible Party:	Michelle Miller-Thomas, M.D. Instructor in Radiology, Mallinckrodt Institute of Radiology, Washington University School of Medicine
ClinicalTrials.gov Identifier:	NCT00962546 History of Changes
Other Study ID Numbers:	HRPO 09-0950
Study First Received:	August 19, 2009
Last Updated:	March 2, 2011
Health Authority:	United States: Institutional Review Board

Keywords provided by Washington University School of Medicine:

cerebral aneurysm
subarachnoid hemorrhage
cerebral vasospasm
computed tomographic perfusion
computed tomographic angiography

Additional relevant MeSH terms:

Aneurysm
Hemorrhage
Subarachnoid Hemorrhage
Vasospasm, Intracranial
Intracranial Aneurysm
Vascular Diseases
Cardiovascular Diseases

Pathologic Processes
Intracranial Hemorrhages
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Intracranial Arterial Diseases

ClinicalTrials.gov processed this record on June 18, 2013

To Top