跳至主要内容
临床试验/NCT02892539
NCT02892539Unknown不适用

A Prospective Multicenter Case Study to Evaluate Radiation Exposure and Risk Factors in Patients During Coronary Angiography

Fan Liu1 个研究点 分布在 1 个国家目标入组 4,000 人开始时间: 2016年8月最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
4,000
试验地点
1
主要终点
Radiation exposure of the patients

研究概览

简要总结

The purpose of this study is to evaluate the radiation exposure in patients undergoing coronary angiography, and to identify reference values for the main radiation doses parameters.

详细描述

Exposure of patients to X-rays during interventional coronary procedures may have deleterious effects, including an increased risk of developing cancer.Individual justification for the procedure and its optimization are the cornerstones of dose-reduction for patients.Radiation exposure is influenced by a variety of technical and clinical factors.Few multicenter data from large populations exist concerning the radiation doses to which patients are exposed during interventional coronary procedures.The aims of this prospective, multicenter survey is to: 1) evaluate the radiation exposure in 4000 patients undergoing coronary angiography by monitoring the parameters of Air kema,fluoroscopy Dose-area product and total Dose-area product; 2) analyze factors associated with variation in radiation dose in everyday clinical practice, such as number of frames, body surface area, sex, age, BMI, arterial approach, fluoroscopy time and so on.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

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 need to perform coronary angiography

排除标准

  • Contrast medium reactions Severe cardiopulmonary insufficiency Uncontrolled severe arrhythmia Uncorrected kaliopenic, digitalism and acid-base imbalance Severe liver and renal dysfunction Hemorrhagic disease Severe infection disease Others who were unwilling to participate the study

结局指标

主要结局

Radiation exposure of the patients

时间窗: during coronary angiography procedure

次要结局

  • Reference values for the main radiation doses parameters(during coronary angiography procedure)

研究者

发起方
Fan Liu
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Fan Liu

Director of Department of Cardiology

The Second Hospital of Hebei Medical University

研究点 (1)

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