Effect Study of Modified Transoesophageal Echocardiography on Cerebral Embolization After Cardiothoracic Surgery
NCT ID: NCT01310608
Last Updated: 2012-08-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
32 participants
INTERVENTIONAL
2011-03-31
2011-06-30
Brief Summary
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Various methods exist to visualize the AA to detect atherosclerosis. Epiaortic ultrasound scanning has become the gold standard, but is seldom used as it interferes often with surgical plan and can only be used after sternotomy. Transesophageal echocardiography (TEE) is a widely used imaging method permitting evaluation of the aorta preoperatively, but assessment of distal AA is hampered by interposition of air-filled trachea between esophagus and AA. The A-View® (Aortic-view) method, a modification of conventional TEE using a fluidfilled balloon, overcomes this limitation. The safety and diagnostic accuracy of the A-View® have successfully been shown in previous studies. The hypothesis of this study is that the use of A-View will reduce cerebral embolization secondary to a change of surgical technique.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
DIAGNOSTIC
DOUBLE
Study Groups
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A-View
A-View
Pre-operative imaging of the thoracic aorta with A-View technique
No A-View
No interventions assigned to this group
Interventions
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A-View
Pre-operative imaging of the thoracic aorta with A-View technique
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Elective surgery
* Stroke Risk Index \<75(Newman, '96)
Exclusion Criteria
* Contra-indication for TEE
* Contra-indication for A-View
* Contra-indication for MRI
18 Years
ALL
No
Sponsors
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Zorgvernieuwing
OTHER
Isala
OTHER
Responsible Party
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Arno P. Nierich
MD. PhD
Principal Investigators
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Arno Nierich, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Isala
Other Identifiers
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A-View 3
Identifier Type: -
Identifier Source: org_study_id
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