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临床试验/NCT01605045
NCT01605045已完成4 期

Efficacy of Fluoroscopy-save Function During Cardiac Catheterization

NYU Langone Health1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2012年4月最近更新:
适应症

试验速览

阶段
4 期
状态
已完成
入组人数
50
试验地点
1
主要终点
Measure of radiation exposure to the patient

研究概览

简要总结

The aim of this study is to evaluate the effects of screening using the fluoroscopy-save function on reduction of radiation exposure and quality of angiogram during cardiac catheterization when compared to traditional cinematography-guided coronary angiography.

详细描述

The study will be a prospective, randomized study of patients undergoing clinically-indicated coronary angiograpy in the New York University (NYU) Langone Medical Center cardiac catheterization laboratory. Patients will be randomized to one of two coronary angiography protocols: (1) Coronary anatomy visualized under fluoroscopy, documented using the fluoroscopy-save function, and further visualized using cinematography only when higher quality is necessary (fluoroscopy-save technique) versus (2) Coronary anatomy visualized and documented using cinematography alone (standard technique). The primary outcome will be a measure of radiation exposure to the patient, surface peak skin dose, as measured by the Gafchromic XR RV3 film strip, which is placed under the patient's back during the procedure. Other outcome measures will include radiation output recorded by the fluoroscopy machine, amount of contrast used, and quality of angiograms performed. To determine if the quality of the angiograms performed using the fluoroscopy-save technique is non-inferior to the standard technique, one extra picture will be taken at random using the mode that the study was not randomized to. For example, in the fluoroscopy-save group, a picture that was not visualized under cinematography during the study will be repeated and documented under cinematograpy. In the standard group, a picture will be repeated and documented using the fluoroscopy-save function. These 2 pictures from each study will then be collated and put together in no particular order with all identifiers removed. These single pictures will be read by 2 interventional cardiologists not involved in the study in a blinded fashion. The degree of coronary artery disease as determined by these 2 readers will be compared between the fluoroscopy-save picture and cinematography picture.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
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

入选标准

  • Patients will be recruited from the cardiac catheterization laboratory at the NYU Langone Medical Center.
  • Patients will be eligible if they are more than 18 years of age and are referred for coronary angiography.

排除标准

  • Patients will be excluded if they have reduced renal function since they must receive as minimal of contrast amount as possible, and if their abdominal circumference is > 45 inches since the quality of images under fluoroscopy alone is poorer in patients with increased abdominal girth.

结局指标

主要结局

Measure of radiation exposure to the patient

时间窗: During coronary angiography

Surface peak skin dose, as measured by the Gafchromic XR RV3 film strip, which is placed under the patient's back during the procedure.

次要结局

  • Dose area product from coronary angiography system(During coronary angiography)
  • Quality of angiograms
  • 30-day events(30 days post-procedure)

研究者

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

James Slater

Director of Cardiac Catheterization Laboratory

NYU Langone Health

研究点 (1)

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