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

NCT01310608 | Completed Phase 3 DMC

• 1 other identifier: A-View 3
• Study Type: interventional
• Target: 32
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Coronary Artery Atherosclerosis

Keywords

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

Outcome Measures

Primary Outcomes (1)

• New diffusion-weighted lesions on cerebral MRI

  3 - 4 Days after intervention

Secondary Outcomes (8)

• The number, size, and location of new ischemic lesions on the postoperative DW-MRI

  3 - 4 Days after intervention

• 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

• Stroke or TIA during the first three postoperative months

  3 months postoperative

• Delirium during hospital stay

  Until hospital discharge

• Quality of life

  6 weeks and 1 year after the intervention

Study Arms (2)

A-View

EXPERIMENTAL

Other: A-View

No A-View

NO INTERVENTION

Interventions

A-View OTHER

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

Also known as: The A-View®, Aortic-view®, Modified transoesophageal echocardiography, FDA: 070515

A-View

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Isolated CABG
• Elective surgery
• Stroke Risk Index \<75(Newman, '96)

You may not qualify if:

• Other than isolated CABG
• Contra-indication for TEE
• Contra-indication for A-View
• Contra-indication for MRI

Sponsors & Collaborators

• Isala: lead
• Zorgvernieuwing: collaborator

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Arno Nierich, MD, PhD

  Isala

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD. PhD

Study Record Dates

• First Submitted: March 7, 2011
• First Posted: March 8, 2011
• Study Start: March 1, 2011
• Primary Completion: March 1, 2011
• Study Completion: June 1, 2011
• Last Updated: August 9, 2012

Record last verified: 2012-08