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临床试验/NCT02618473
NCT02618473已完成不适用

Impact of a Motion Correction Algorithm on Image Quality and Diagnostic Utility in Patients Undergoing CT Angiography: A Randomized Controlled Trial

Odense University Hospital1 个研究点 分布在 1 个国家目标入组 140 人开始时间: 2013年1月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
140
试验地点
1
主要终点
images with non diagnostic image quality

研究概览

简要总结

The aim of this study was to investigate the effect of a new motion correction algorithm on image quality and diagnostic utility in unselected patients undergoing coronary cardiac computed tomography, and to investigate if this motion correction algorithm can compensate for the usual use of intravenously medication (beta-blockers) before the scan.

详细描述

Aims:

To investigate the motion correction algorithm Snapshot-Freeze(SSF) compared to standard reconstruction(STD) in patients randomized to receive beta-blockers(BB) or no beta-blockers(non-BB) before coronary CT angiography (CCTA), and to investigate if SSF can replace BB.

Methods:

The study included 140 consecutively recruited patients scheduled to CCTA to rule out coronary artery disease.

The inclusion criteria were: age ≥ 18 years, Glomerular filtration rate ≥ 60 mL/min, Heart Rate between 60 and 85 bpm before the scan. The exclusion criteria were: irregular heart rhythm or history of allergic reaction to contrast agents. Patients were randomized to the BB group or the non-BB group. The trial complied with the Declaration of Helsinki and was approved by the local ethics committee. Written informed consent was obtained from all patients.

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
否

入选标准

  • •age ≥ 18 years,
  • •glomerular filtration rate ≥ 60 mL/min,
  • •heart rate between 60 and 85 bpm before the scan

排除标准

  • •irregular heart rhythm
  • •history of allergic reaction to contrast agents

研究组 & 干预措施

seloken

No Intervention

In "seloken" arm, patients performs the cardiac CT procedure regarding the national scan guidelines, ande receive 5-10 intravenous seloken, until heart rate below 60 beats pr minit is achieved.

non-seloken

Experimental

Patients randomized to "non-seloken", do not receive any medication.

干预措施: non-seloken (Other)

结局指标

主要结局

images with non diagnostic image quality

时间窗: up to 1 year

number of non diagnostic images.

次要结局

  • images with Excellent image quality(up to 1 year)
  • motion artifacts(up to 1 year)

研究者

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

Hussam Mahmoud Sheta

M.D

Odense University Hospital

研究点 (1)

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