RATATOUILLE Study (inteRnATional hAnd funcTiOn stUdy Following dIstaL radiaL accEss)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Prevalence of hand dysfunction
研究概览
简要总结
Traditionally, coronary angiograms are performed through the radial artery which is accessed above the palm of the 'right' hand. In recent years, some cardiologists are performing this procedure from the back of the wrist in as the radial artery courses through the anatomical snuffbox (distal radial access). The aim of this study is to determine the prevalence of hand dysfunction following coronary angiography via the distal radial artery.
详细描述
In this multi centre observational registry, we will recruit patients undergoing planned invasive coronary angiography. Inclusion criteria include:
- Age ≥ 18 years.
- The distal radial artery must be palpable and non-occlusive flow must be confirmed by Doppler ultrasound.
- Patient should be able to comply with the protocol.
- Provide written informed consent before study participation.
The primary endpoint is the overall prevalence of hand dysfunction defined as any significant reduction from baseline score in any of the following five domains:
DASH score Levine Katz score VAS score Sensory function Pinch grip strength.
Specifically hand function will be assessed at 4 time points using simple tests of hand strength, sensation and ultrasound to assess the arterial latency.
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
- •Age ≥ 18 years.
- •The distal radial artery must be palpable and non-occlusive flow must be confirmed by Doppler ultrasound.
- •Patient should be able to comply with the protocol.
- •Provide written informed consent before study participation.
排除标准
- •Obligatory femoral or forearm radial access
- •Previous ipsilateral forearm radial artery occlusion.
- •Undergoing another procedure involving the ipsilateral radial artery, performed between the index procedure and the follow-up date.
- •Enrolment in another study that competes or interferes with this study.
- •Poor clinical condition like cardiogenic shock, that prohibits pre- and postprocedural function tests.
- •Any other condition which, in the opinion of the investigator or operator, may pose a significant hazard to the subject if he or she is enrolled in the study.
- •Co-morbidity that excludes patient follow-up.
结局指标
主要结局
Prevalence of hand dysfunction
时间窗: 1 month
Any significant deterioration from baseline in hand function according to the 5 studied domains.
次要结局
- Hemostasis duration(Day 0)
- Success of distal radial access(Day 0)
- Vascular access complications (other than occlusion and bleeding)(Day 0)
- Puncture time(Day 0)
- Radial artery occlusion - including level of occlusion (prox/distal)(0-12 months)
- Fluoroscopy time(Day 0)
研究者
Dr Thomas J Ford
Honorary Clinical Lecturer
University of Glasgow