Chest CT With Iterative Reconstruction as an Alternative to Conventional Chest X-ray Prior to Heart Surgery (CRICKET)
Ultra Low-dose Chest CT With Iterative Reconstructions as an Alternative to Conventional Chest X-ray Prior to Heart Surgery
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
注册 (实际的)
阶段
- 不适用
联系人和位置
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
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
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:
|
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
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
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
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
-
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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