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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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
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
Intracranial Aneurysm
Subarachnoid Hemorrhage
Vasospasm, Intracranial
Brain Diseases
Cardiovascular Diseases
Central Nervous System Diseases
Cerebrovascular Disorders
Intracranial Arterial Diseases
Intracranial Hemorrhages
Nervous System Diseases
Pathologic Processes
Vascular Diseases

ClinicalTrials.gov processed this record on November 20, 2014