Effect Study of Modified Transoesophageal Echocardiography on Cerebral Embolization After Cardiothoracic Surgery

NCT ID: NCT01310608

Last Updated: 2012-08-09

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-03-31

Study Completion Date

2011-06-30

Brief Summary

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Patients undergoing cardiac surgery frequently develop neurologic complications, ranging from subtle cognitive changes to evident confusion, delirium, and stroke. This continuum of complications is commonly caused by embolization in the brain due to manipulation of atherosclerotic parts of the aorta ascendens (AA) during surgery. Timely detection of AA atherosclerosis before surgery enables the surgeon to consider changes of the surgical plan, to reduce the risk of embolization and thus subsequent neurologic complications.

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.

Detailed Description

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Conditions

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Coronary Artery Atherosclerosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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A-View

Group Type EXPERIMENTAL

A-View

Intervention Type OTHER

Pre-operative imaging of the thoracic aorta with A-View technique

No A-View

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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A-View

Pre-operative imaging of the thoracic aorta with A-View technique

Intervention Type OTHER

Other Intervention Names

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The A-View® Aortic-view® Modified transoesophageal echocardiography FDA: 070515

Eligibility Criteria

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Inclusion Criteria

* Isolated CABG
* Elective surgery
* Stroke Risk Index \<75(Newman, '96)

Exclusion Criteria

* Other than isolated CABG
* Contra-indication for TEE
* Contra-indication for A-View
* Contra-indication for MRI
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Zorgvernieuwing

OTHER

Sponsor Role collaborator

Isala

OTHER

Sponsor Role lead

Responsible Party

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Arno P. Nierich

MD. PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

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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