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

August 7, 2012 updated by: Arno P. Nierich, Isala

Effect of Preoperative Imaging of the Ascending Aorta With Modified Transoesophageal Echocardiography on New Dw-MRI Lesions After Cardiac Surgery

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

32

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: A-View
Other: A-View
Pre-operative imaging of the thoracic aorta with A-View technique
Other Names:
  • The A-View®
  • Aortic-view®
  • Modified transoesophageal echocardiography
  • FDA: 070515
No Intervention: No A-View

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
New diffusion-weighted lesions on cerebral MRI
Time Frame: 3 - 4 Days after intervention
3 - 4 Days after intervention

Secondary Outcome Measures

Outcome Measure
Time Frame
The number, size, and location of new ischemic lesions on the postoperative DW-MRI
Time Frame: 3 - 4 Days after intervention
3 - 4 Days after intervention
Any neurologic event during the first six postoperative weeks, which is manifested as either stroke, or transient ischemic attack (TIA), epileptic insults, or delirium, or cognitive deficit
Time Frame: 6 weeks postoperative
6 weeks postoperative
Stroke or TIA during the first three postoperative months
Time Frame: 3 months postoperative
3 months postoperative
Delirium during hospital stay
Time Frame: Until hospital discharge
Until hospital discharge
Quality of life
Time Frame: 6 weeks and 1 year after the intervention
6 weeks and 1 year after the intervention
Number of "HITS" detected by Transcranial Doppler
Time Frame: peroperive
peroperive
Incidence of Near Infrared Spectrography desaturations (NIRO 2000)
Time Frame: Peroperative
Peroperative
Short psychometric test
Time Frame: 6 weeks after intervention
6 weeks after intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Isala

Collaborators

Zorgvernieuwing

Investigators

  • Principal Investigator: Arno Nierich, MD, PhD, Isala

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2011

Primary Completion (Actual)

March 1, 2011

Study Completion (Actual)

June 1, 2011

Study Registration Dates

First Submitted

March 7, 2011

First Submitted That Met QC Criteria

March 7, 2011

First Posted (Estimate)

March 8, 2011

Study Record Updates

Last Update Posted (Estimate)

August 9, 2012

Last Update Submitted That Met QC Criteria

August 7, 2012

Last Verified

August 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A-View 3

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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