NCT00962546

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
4

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Sep 2009

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 19, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 20, 2009

Completed
12 days until next milestone

Study Start

First participant enrolled

September 1, 2009

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
Last Updated

December 9, 2014

Status Verified

December 1, 2014

Enrollment Period

2.2 years

First QC Date

August 19, 2009

Last Update Submit

December 8, 2014

Conditions

Keywords

cerebral aneurysmsubarachnoid hemorrhagecerebral vasospasmcomputed tomographic perfusioncomputed tomographic angiography

Outcome Measures

Primary Outcomes (1)

  • CT perfusion parameters

    at time of catheter angiogram

Secondary Outcomes (2)

  • Disposition at discharge

    At time of hospital discharge

  • vessel narrowing by CT angiography

    at time of catheter angiogram

Study Arms (1)

CTA/CTP

Patients undergo CTA/CTP imaging prior to cerebral angiography

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients admitted to the neurological intensive care unit with subarachnoid hemorrhage due to rupture of a cerebral aneurysm

You may qualify if:

  • subarachnoid hemorrhage after aneurysm rupture

You may not qualify if:

  • renal insufficiency
  • pregnancy
  • contrast reaction

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Barnes-Jewish Hospital

St Louis, Missouri, 63110, United States

Location

Related Publications (3)

  • 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.

MeSH Terms

Conditions

Vasospasm, IntracranialIntracranial AneurysmSubarachnoid Hemorrhage

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesIntracranial Arterial DiseasesAneurysmIntracranial HemorrhagesHemorrhagePathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Michelle Miller-Thomas, MD

    Washington University School of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

August 19, 2009

First Posted

August 20, 2009

Study Start

September 1, 2009

Primary Completion

December 1, 2011

Study Completion

December 1, 2011

Last Updated

December 9, 2014

Record last verified: 2014-12

Locations