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Completed

NCT Number: NCT01310608

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

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

A-View

Other

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

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

Primary outcomes

  1. New diffusion-weighted lesions on cerebral MRI

    Time frame: 3 - 4 Days after intervention

Secondary outcomes

  1. The number, size, and location of new ischemic lesions on the postoperative DW-MRI

    Time frame: 3 - 4 Days after intervention

  2. 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

  3. Stroke or TIA during the first three postoperative months

    Time frame: 3 months postoperative

  4. Delirium during hospital stay

    Time frame: Until hospital discharge

  5. Quality of life

    Time frame: 6 weeks and 1 year after the intervention

  6. Number of "HITS" detected by Transcranial Doppler

    Time frame: peroperive

  7. Incidence of Near Infrared Spectrography desaturations (NIRO 2000)

    Time frame: Peroperative

  8. Short psychometric test

    Time frame: 6 weeks after intervention

Sponsors and collaborators

Lead sponsor

Isala

Other

Collaborators

  • Zorgvernieuwing

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Mar 8, 2011
Registry last updated
Aug 9, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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