Association Between Radial Artery Intervention and Development of Neuropathy in the Hand - A Prospective Study - The ACCESS IV Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- Neurophysiological measurements
研究概览
简要总结
Evaluation of potential nerve damage after radial CAG/PCI.
详细描述
Prospective patients scheduled for radial CAG/ PCI will be enrolled in the study. Prior to the procedure, sensory and motor nerve examination is performed at the wrists in both arms / hands. The examination is performed on both the median nerve and the ulnar nerve. Each patient acts as their own control. The nerve test is repeated bilaterally 1 month after the procedure. This creates 2 groups, A and B.
Patients will be asked to complete 2 questionnaires in relation to hand and arm symptoms. The patients ability to perform certain activities before and after the CAG/PCI procedure are also addressed. In addition, a diagnostic tool (Katz chart) will be completed, also before and after the CAG/PCI procedure.
Hypothesis
Radial access is associated with an increased risk of pain and an increased incidence of nerve damage similar to the median nerve at the carpal tunnel or the ulnar nerve at the Guyon's canal.
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
- •The patient must be able to give informed consent
排除标准
- •Pregnancy
- •Negative Barbeau test
结局指标
主要结局
Neurophysiological measurements
时间窗: Aprox 1 hour
The primary aim is the incidence/presence of electrofysiological signs of median and/or ulnar nerve lesion at the wrist and the presence of carpaltunnel syndrom. The electrodiagnosis of carpaltunnelsyndrom will be determined from the clinical picture and signs of prolonged distal motor lantency and reduced motor and sensory nerveconduction velocity across the wrist and/or reduced amplitudes of the median nerve and normal ulnar nerve at the wrist.
次要结局
- Severity of hand symptoms and hand dysfunction(10 min)
研究者
Christian Juhl Terkelsen
Professor, Professor, Chief Physician, PhD.
Aarhus University Hospital Skejby