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

Effect of Preoperative Imaging of the Ascending Aorta With Modified Transoesophageal Echocardiography on New Dw-MRI Lesions After Cardiac Surgery

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01310608
Enrollment
32
Registered
2011-03-08
Start date
2011-03-31
Completion date
2011-06-30
Last updated
2012-08-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary Artery Atherosclerosis

Keywords

Atherosclerosis aorta, A-View, Distal ascending aorta, Transoesophageal echocardiography, CABG, Cerebral embolisation

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.

Interventions

OTHERA-View

Pre-operative imaging of the thoracic aorta with A-View technique

Sponsors

Zorgvernieuwing
CollaboratorOTHER
Isala
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

Design outcomes

Primary

MeasureTime frame
New diffusion-weighted lesions on cerebral MRI3 - 4 Days after intervention

Secondary

MeasureTime frame
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 deficit6 weeks postoperative
Stroke or TIA during the first three postoperative months3 months postoperative
Delirium during hospital stayUntil hospital discharge
The number, size, and location of new ischemic lesions on the postoperative DW-MRI3 - 4 Days after intervention
Number of HITS detected by Transcranial Dopplerperoperive
Incidence of Near Infrared Spectrography desaturations (NIRO 2000)Peroperative
Short psychometric test6 weeks after intervention
Quality of life6 weeks and 1 year after the intervention

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026