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临床试验/NCT04023838
NCT04023838Unknown不适用

Randomized Comparison of Radiation Exposure in Coronary Angiography Between Right Conventional and Left Distal Radial Artery Approach: The DOSE Trial

Chonnam National University Hospital0 个研究点目标入组 100 人开始时间: 2019年8月最近更新:
适应症

试验速览

阶段
不适用
入组人数
100
主要终点
Radiation dose of the operator (µSv)

研究概览

简要总结

Randomized comparison of radiation exposure in coronary angiography between right conventional and left distal radial artery approach

详细描述

The left snuffbox approach is expected to be easier to perform because of less severe tortuosity of the clavicle artery. However, clinical validation of the snuffbox approach was not completed compared with the conventional radial approach. Especially, there is no clinical data on the comparison of the radiation dose in both approaches. To date, there have been some studies on the radiation dose between the left and right radial artery and femoral artery puncture site, but no studies have been conducted on the left snuffbox approach.

The purpose of this study was to compare the radiation doses of the two interventional radiologists by randomly assigning coronary angiography to the left snuffbox approach and right conventional radial approach.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
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

  • Patients who are a palpable right radial artery and left distal radial artery
  • The decision to participate voluntarily in this study and the written consent of the patient

排除标准

  • Patients who are not palpable right radial artery and left distal radial artery
  • Patients who have arteriovenous fistula
  • Patients presenting with acute myocardial infarction
  • Patients who need to perform coronary angiography via femoral approach, such as shock state
  • Patients who have atrioventricular block on the electrocardiogram
  • Patients who have a plan to perform Ergonovine provocation test
  • Patients who need percutaneous coronary intervention
  • Patients who are not appropriate for this study

结局指标

主要结局

Radiation dose of the operator (µSv)

时间窗: Through procedure completion, up to 6 hours

Radiation dose (µSv) of the operator's head, hand, and body will be compared between right conventional radial artery approach and left snuffbox approach group.

次要结局

  • Fluoroscopy time for coronary angiography (second)(Through procedure completion, up to 6 hours)
  • Dose-area product (mGy*cm2)(Through procedure completion, up to 6 hours)
  • Success rate of radial puncture (%)(Through procedure completion, up to 6 hours)
  • Hemostasis duration (minute)(During hospitalization, up to 1 month)
  • Cannulation time (second)(Through procedure completion, up to 6 hours)
  • Puncture site complication after hemostasis(During hospitalization, up to 1 month)

研究者

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

Myung Ho Jeong

Professor

Chonnam National University Hospital

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