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

This study has been completed.
Sponsor:
Collaborator:
Zorgvernieuwing
Information provided by (Responsible Party):
Arno P. Nierich, Isala Klinieken
ClinicalTrials.gov Identifier:
NCT01310608
First received: March 7, 2011
Last updated: August 7, 2012
Last verified: August 2012
History of Changes
  Purpose

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 Intervention Phase
Coronary Artery Atherosclerosis
 Other: A-View
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Isala Klinieken:

Primary Outcome Measures:
  • New diffusion-weighted lesions on cerebral MRI [ Time Frame: 3 - 4 Days after intervention ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The number, size, and location of new ischemic lesions on the postoperative DW-MRI [ Time Frame: 3 - 4 Days after intervention ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Stroke or TIA during the first three postoperative months [ Time Frame: 3 months postoperative ] [ Designated as safety issue: No ]
  • Delirium during hospital stay [ Time Frame: Until hospital discharge ] [ Designated as safety issue: No ]
  • Quality of life [ Time Frame: 6 weeks and 1 year after the intervention ] [ Designated as safety issue: No ]
  • Number of "HITS" detected by Transcranial Doppler [ Time Frame: peroperive ] [ Designated as safety issue: No ]
  • Incidence of Near Infrared Spectrography desaturations (NIRO 2000) [ Time Frame: Peroperative ] [ Designated as safety issue: No ]
  • Short psychometric test [ Time Frame: 6 weeks after intervention ] [ Designated as safety issue: No ]

Enrollment: 32
Study Start Date: March 2011
Study Completion Date: June 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01310608

Sponsors and Collaborators
Isala Klinieken
Zorgvernieuwing
Investigators
Principal Investigator: Arno Nierich, MD, PhD Isala Klinieken
  More Information

No publications provided

Responsible Party: Arno P. Nierich, MD. PhD, Isala Klinieken
ClinicalTrials.gov Identifier: NCT01310608     History of Changes
Other Study ID Numbers: A-View 3
Study First Received: March 7, 2011
Last Updated: August 7, 2012
Health Authority: Netherlands: Medical Ethics Review Committee (METC)

Keywords provided by Isala Klinieken:
Atherosclerosis aorta
A-View
Distal ascending aorta
 Transoesophageal echocardiography
CABG
Cerebral embolisation

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

ClinicalTrials.gov processed this record on May 22, 2013