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临床试验/NCT02173470
NCT02173470终止不适用

Ultra Low-dose Chest CT With Iterative Reconstructions as an Alternative to Conventional Chest X-ray Prior to Heart Surgery

UMC Utrecht4 个研究点 分布在 2 个国家目标入组 866 人开始时间: 2014年9月最近更新:
适应症

试验速览

阶段
不适用
状态
终止
发起方
UMC Utrecht
入组人数
866
试验地点
4
主要终点
Postoperative stroke

研究概览

简要总结

To assess if information about aortic calcification obtained from routine preoperative ultra low-dose chest CT lowers the postoperative stroke rate in patients undergoing heart surgery by optimizing surgical strategy compared to the normal work-up with a conventional chest X-ray.

详细描述

During heart surgery the aorta is clamped to initiate cardiopulmonary bypass. This may crush aortic calcifications causing them to embolize to the brain causing a stroke which is a devastating complication for the patient. A chest X-ray is routinely performed prior to heart surgery. It provides no information about aortic calcification. Imaging by a chest computed tomography (CT) scan provides detailed information on aortic calcification but has higher radiation exposure and thus is not used routinely. Recently iterative reconstruction (IR) techniques have become available that allow chest CT to be performed at markedly reduced dose with retained image quality. Routine use of low dose chest CT with IR prior to heart surgery may identify patients with a severely calcified aorta in which the surgery may subsequently adapted to minimize or avoid aortic manipulation which may reduce stroke rate.

In this multicenter randomized controlled clinical trial the effect of preoperative chest CT on postoperative stroke is investigated. In total 1724 patients will be included of whom 862 patients will receive an additional CT to standard care and 862 patients will receive routine care.

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
None

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

  • 18 years old or older
  • Scheduled to undergo heart surgery
  • Provide written informed consent

排除标准

  • Patient not meeting inclusion criteria
  • Pregnant women
  • Scheduled to undergo transcatheter aortic valve insertion procedure (since these patients receive a standard preoperative CT)
  • Chest or cardiac CT in the past three months
  • Emergency surgery
  • Concomitant or previous participation in a study that prohibits the patient from participating in a study that exposed the patient to radiation
  • Unwillingness to be informed about unrequested findings on the CT scan

结局指标

主要结局

Postoperative stroke

时间窗: Participants will be followed for the duration of hospital stay, an expected average of 5 days

Percentage of patients suffering from in-hospital postoperative stroke (central neurological defect that either recovers spontaneously or is permanent) after heart surgery.

次要结局

  • Altered surgical approach(The surgery will take place the day after hospital administration.)

研究者

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

Annemarie den Harder

MD

UMC Utrecht

研究点 (4)

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