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

Coronary Artery Atherosclerosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01310608
• Other study ID #: A-View 3
• Status: Completed
• Phase: Phase 3
• First received: March 7, 2011
• Last updated: August 7, 2012
• Start date: March 2011
• Est. completion date: June 2011

Study information

• Verified date: August 2012
• Source: Isala
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: Medical Ethics Review Committee (METC)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: June 2011
• Est. primary completion date: March 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Atherosclerosis
• Coronary Artery Atherosclerosis
• Coronary Artery Disease
• Myocardial Ischemia

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Isala	Zorgvernieuwing

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	New diffusion-weighted lesions on cerebral MRI		3 - 4 Days after intervention	No
Secondary	The number, size, and location of new ischemic lesions on the postoperative DW-MRI		3 - 4 Days after intervention	No
Secondary	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		6 weeks postoperative	No
Secondary	Stroke or TIA during the first three postoperative months		3 months postoperative	No
Secondary	Delirium during hospital stay		Until hospital discharge	No
Secondary	Quality of life		6 weeks and 1 year after the intervention	No
Secondary	Number of "HITS" detected by Transcranial Doppler		peroperive	No
Secondary	Incidence of Near Infrared Spectrography desaturations (NIRO 2000)		Peroperative	No
Secondary	Short psychometric test		6 weeks after intervention	No