Clinical trial NCT01310608: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Coronary Artery Atherosclerosis
Keywords: Atherosclerosis aorta
A-View
Distal ascending aorta
Transoesophageal echocardiography
CABG
Cerebral embolisation
Lead sponsor: Isala
Sponsor class: OTHER
Collaborators: name: Zorgvernieuwing
First posted: 2011-03-08
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.


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

Primary outcomes:
measure: New diffusion-weighted lesions on cerebral MRI
timeFrame: 3 - 4 Days after intervention
Secondary outcomes:
measure: The number, size, and location of new ischemic lesions on the postoperative DW-MRI
timeFrame: 3 - 4 Days after intervention
measure: 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
timeFrame: 6 weeks postoperative
measure: Stroke or TIA during the first three postoperative months
timeFrame: 3 months postoperative
measure: Delirium during hospital stay
timeFrame: Until hospital discharge
measure: Quality of life
timeFrame: 6 weeks and 1 year after the intervention
measure: Number of "HITS" detected by Transcranial Doppler
timeFrame: peroperive
measure: Incidence of Near Infrared Spectrography desaturations (NIRO 2000)
timeFrame: Peroperative
measure: Short psychometric test
timeFrame: 6 weeks after intervention
Other outcomes:
Locations:
Study officials:
affiliation: Isala
name: Arno Nierich, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: