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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
Isala
About
Eligibility
Locations
Arms
Outcomes
Full info

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

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    March 7, 2011
    Last Updated
    August 7, 2012
    Sponsor
    Isala
    Collaborators
    Zorgvernieuwing
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    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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