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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00962546
Other study ID # HRPO 09-0950
Secondary ID
Status Completed
Phase N/A
First received August 19, 2009
Last updated December 8, 2014
Start date September 2009
Est. completion date December 2011

Study information

Verified date December 2014
Source Washington University School of Medicine
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 4
Est. completion date December 2011
Est. primary completion date December 2011
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- subarachnoid hemorrhage after aneurysm rupture

Exclusion Criteria:

- renal insufficiency

- pregnancy

- contrast reaction

Study Design

Observational Model: Cohort, Time Perspective: Prospective


Locations

Country Name City State
United States Barnes-Jewish Hospital St. Louis Missouri

Sponsors (1)

Lead Sponsor Collaborator
Washington University School of Medicine

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. E — View Citation

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 haemor — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary CT perfusion parameters at time of catheter angiogram No
Secondary Disposition at discharge At time of hospital discharge No
Secondary vessel narrowing by CT angiography at time of catheter angiogram No
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