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Chest CT With Iterative Reconstruction as an Alternative to Conventional Chest X-ray Prior to Heart Surgery (CRICKET)

2020年6月8日 更新者:Annemarie den Harder、UMC Utrecht

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

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.

研究概览

详细说明

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.

研究类型

介入性

注册 (实际的)

866

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

      • Budapest、匈牙利
        • Heart and Vascular Center Semmelweis University
      • Rotterdam、荷兰
        • Erasmus Medical Center
      • Utrecht、荷兰、3508GA
        • University Medical Center Utrecht

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:诊断
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
无干预:Control
Routine clinical care (which includes a conventional chest X-ray).
实验性的:CT scan
Routine clinical care, which includes a chest x-ray, with an additional ultra low-dose non contrast enhanced chest CT with IR (performed preoperatively).
The intervention group receives both standard care (chest x-ray) and an ultra low dose CT thorax without contrast.
其他名称:
  • CT检查

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Postoperative stroke
大体时间: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.
Participants will be followed for the duration of hospital stay, an expected average of 5 days

次要结果测量

结果测量
措施说明
大体时间
Altered surgical approach
大体时间:The surgery will take place the day after hospital administration.
Percentage of patients in which the surgical approach is altered based on information derived from the preoperative chest CT.
The surgery will take place the day after hospital administration.

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

调查人员

  • 首席研究员:Ricardo PJ Budde, MD, PhD、Erasmus MC Rotterdam

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2014年9月1日

初级完成 (实际的)

2019年10月1日

研究完成 (实际的)

2020年6月1日

研究注册日期

首次提交

2014年6月17日

首先提交符合 QC 标准的

2014年6月24日

首次发布 (估计)

2014年6月25日

研究记录更新

最后更新发布 (实际的)

2020年6月11日

上次提交的符合 QC 标准的更新

2020年6月8日

最后验证

2020年6月1日

更多信息

与本研究相关的术语

其他研究编号

  • NL47293.041.13
  • 837001403 (其他赠款/资助编号:ZonMw)

计划个人参与者数据 (IPD)

研究数据/文件

  1. 研究协议
    信息评论:Ultra low-dose chest ct with iterative reconstructions as an alternative to conventional chest x-ray prior to heart surgery (CRICKET study): Rationale and design of a multicenter randomized trial.

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