Effect Study of Modified Transoesophageal Echocardiography on Cerebral Embolization After Cardiothoracic Surgery
Primary Purpose
Coronary Artery Atherosclerosis
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
A-View
Sponsored by
About this trial
This is an interventional diagnostic trial for Coronary Artery Atherosclerosis focused on measuring Atherosclerosis aorta, A-View, Distal ascending aorta, Transoesophageal echocardiography, CABG, Cerebral embolisation
Eligibility 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
A-View
No A-View
Arm Description
Outcomes
Primary Outcome Measures
New diffusion-weighted lesions on cerebral MRI
Secondary Outcome Measures
The number, size, and location of new ischemic lesions on the postoperative DW-MRI
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
Stroke or TIA during the first three postoperative months
Delirium during hospital stay
Quality of life
Number of "HITS" detected by Transcranial Doppler
Incidence of Near Infrared Spectrography desaturations (NIRO 2000)
Short psychometric test
Full Information
NCT ID
NCT01310608
First Posted
March 7, 2011
Last Updated
August 7, 2012
Sponsor
Isala
Collaborators
Zorgvernieuwing
1. Study Identification
Unique Protocol Identification Number
NCT01310608
Brief Title
Effect Study of Modified Transoesophageal Echocardiography on Cerebral Embolization After Cardiothoracic Surgery
Official Title
Effect of Preoperative Imaging of the Ascending Aorta With Modified Transoesophageal Echocardiography on New Dw-MRI Lesions After Cardiac Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
August 2012
Overall Recruitment Status
Completed
Study Start Date
March 2011 (undefined)
Primary Completion Date
March 2011 (Actual)
Study Completion Date
June 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Isala
Collaborators
Zorgvernieuwing
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Atherosclerosis
Keywords
Atherosclerosis aorta, A-View, Distal ascending aorta, Transoesophageal echocardiography, CABG, Cerebral embolisation
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
32 (Actual)
8. Arms, Groups, and Interventions
Arm Title
A-View
Arm Type
Experimental
Arm Title
No A-View
Arm Type
No Intervention
Intervention Type
Other
Intervention Name(s)
A-View
Other Intervention Name(s)
The A-View®, Aortic-view®, Modified transoesophageal echocardiography, FDA: 070515
Intervention Description
Pre-operative imaging of the thoracic aorta with A-View technique
Primary Outcome Measure Information:
Title
New diffusion-weighted lesions on cerebral MRI
Time Frame
3 - 4 Days after intervention
Secondary Outcome Measure Information:
Title
The number, size, and location of new ischemic lesions on the postoperative DW-MRI
Time Frame
3 - 4 Days after intervention
Title
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
Title
Stroke or TIA during the first three postoperative months
Time Frame
3 months postoperative
Title
Delirium during hospital stay
Time Frame
Until hospital discharge
Title
Quality of life
Time Frame
6 weeks and 1 year after the intervention
Title
Number of "HITS" detected by Transcranial Doppler
Time Frame
peroperive
Title
Incidence of Near Infrared Spectrography desaturations (NIRO 2000)
Time Frame
Peroperative
Title
Short psychometric test
Time Frame
6 weeks after intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Arno Nierich, MD, PhD
Organizational Affiliation
Isala
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Effect Study of Modified Transoesophageal Echocardiography on Cerebral Embolization After Cardiothoracic Surgery
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