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临床试验/NCT01310608
NCT01310608已完成3 期

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

Isala0 个研究点目标入组 32 人开始时间: 2011年3月1日最近更新:
适应症

试验速览

阶段
3 期
状态
已完成
发起方
Isala
入组人数
32
主要终点
New diffusion-weighted lesions on cerebral MRI

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

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

结局指标

主要结局

New diffusion-weighted lesions on cerebral MRI

时间窗: 3 - 4 Days after intervention

次要结局

  • 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)
  • Number of "HITS" detected by Transcranial Doppler(peroperive)
  • Incidence of Near Infrared Spectrography desaturations (NIRO 2000)(Peroperative)
  • Short psychometric test(6 weeks after intervention)

研究者

发起方
Isala
申办方类型
Other
责任方
Principal Investigator
主要研究者

Arno P. Nierich

MD. PhD

Isala

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