NCT05111496已完成不适用
Evaluation of the Radiological Dose Delivered to Risky Interventional Cardiology Patients (Optidose)
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
- 83
- 试验地点
- 2
- 主要终点
- Dose measured to the patient's skin at the entrance to the X-ray beam
研究概览
简要总结
The purpose of this study is therefore to study the actual doses of X-rays delivered to the patient's skin during recanalization of a coronary artery in a context of Chronic Total Occlusion
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 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
- 否
入选标准
- •Patient over 18 years-old
- •Patient requiring intervention with a predicted risk of exceeding the radiological threshold (Air Kerma> 3Gy): complex coronary dilation, coronary recanalization
- •Patient benefiting from a social protection insurance
- •Patient having been informed and not objecting to this research
排除标准
- •Patient refusal to participate in the study
- •Patient with known radiosensitivity factors (eg: Lupus)
- •Patient having had radiotherapy treatment of the thoracic region.
- •Patient whose sum of radiation doses to the skin> 0.5 Gy in the thoracic region in the 3 months preceding inclusion.
- •Patient participating in another clinical study
- •Protected patient: adult under guardianship, curatorship or other legal protection, deprived of liberty by judicial or administrative decision
- •Pregnant or breastfeeding woman
- •Patient hospitalized without consent.
研究组 & 干预措施
Patient requiring intervention (complex coronary dilation or coronary recanalization)
Patient requiring intervention with a predicted risk of exceeding the radiological threshold (Air Kerma> 3Gy): complex coronary dilation, coronary recanalization
干预措施: Gafchromic film (Radiation)
结局指标
主要结局
Dose measured to the patient's skin at the entrance to the X-ray beam
时间窗: 1 month
Dose expressed in Gy (Peak skin dose).
次要结局
未报告次要终点
研究者
研究点 (2)
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