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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01310608
Recruitment Status : Completed
First Posted : March 8, 2011
Last Update Posted : August 9, 2012
Information provided by (Responsible Party):
Arno P. Nierich, Isala Klinieken

Brief Summary:

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.

Condition or disease Intervention/treatment Phase
Coronary Artery Atherosclerosis Other: A-View Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Diagnostic
Official Title: Effect of Preoperative Imaging of the Ascending Aorta With Modified Transoesophageal Echocardiography on New Dw-MRI Lesions After Cardiac Surgery
Study Start Date : March 2011
Actual Primary Completion Date : March 2011
Actual Study Completion Date : June 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Atherosclerosis
U.S. FDA Resources

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

Primary Outcome Measures :
  1. New diffusion-weighted lesions on cerebral MRI [ Time Frame: 3 - 4 Days after intervention ]

Secondary Outcome Measures :
  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 ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01310608

Sponsors and Collaborators
Principal Investigator: Arno Nierich, MD, PhD Isala

Responsible Party: Arno P. Nierich, MD. PhD, Isala Klinieken Identifier: NCT01310608     History of Changes
Other Study ID Numbers: A-View 3
First Posted: March 8, 2011    Key Record Dates
Last Update Posted: August 9, 2012
Last Verified: August 2012

Keywords provided by Arno P. Nierich, Isala Klinieken:
Atherosclerosis aorta
Distal ascending aorta
Transoesophageal echocardiography
Cerebral embolisation

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Coronary Disease
Heart Diseases