COmparison of the HaNd DysFunction in Coronary Diagnosis and INtervention Via Distal vs Conventional Radial AccEss: Randomized Controlled Trial (CONFINE)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 640
- 主要终点
- Hand Numbness
研究概览
简要总结
Randomized controlled trial for comparison of the hand dysfunction in coronary diagnosis and intervention via distal vs conventional radial access
详细描述
Coronary diagnosis and intervention via distal radial access has gradually become an alternative access to the conventional radial access because of its advantages of reducing radial artery occlusion (RAO), shortening compression time, and decreasing patient discomfort. However, as awareness of distal radial access has increased, some patients have been found to have symptoms such as abnormal hand sensation and inflexibility after the procedure.
The primary objective is to assess hand function after coronary diagnosis and intervention via distal vs conventional radial access at 24 hours and 1 month.
Hand sensory and motor dysfunction will be assessed by:
- Consultation and physical examination
- Hand grip test
- Hand pinch test (lateral pinch)
- Monofilament sensory test
- Quick DASH questionnaire
- High-frequent ultrasound The other endpoints include the success rate of puncture, the success rate of single-attempt puncture, time of puncture, procedural duration, duration of hemostasis, vascular complication, etc.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Indications for coronary diagnosis and intervention
- •Distal and conventional radial artery pulsation are palpable
- •Patient should be able to comply with the protocol
排除标准
- •Age < 18 years or ≥ 90 years
- •Height ≥ 185 cm
- •Acute STEMI
- •Haemodynamic instability
- •Contraindications to puncture at the puncture site (such as infection, scarring or indwelling needles)
- •Enrollment in another study that competes or interferes with this study
研究组 & 干预措施
Distal radial artery access group
Subjects randomized to experimental group were underwent coronary diagnosis and intervention via distal radial artery access.
干预措施: Distal radial artery access (Procedure)
Conventional radial artery access group
Subjects randomized to active comparator group were underwent coronary diagnosis and intervention via conventional radial artery access.
干预措施: Conventional radial artery access (Procedure)
结局指标
主要结局
Hand Numbness
时间窗: 24 hours after procedure
Number of participants with the hand numbness is evaluated through clinical consultations at 24 hours after procedure.
次要结局
- Thumb and Index Finger Pinch Test(24 hours before and after procedure, 1 month after procedure)
- Hand Paresthesia(24 hours and 1 month after procedure)
- Hand Clumsiness(24 hours and 1 month after procedure)
- Nerve Injury(24 hours and 1 month after procedure)
- Hand Grip Test(24 hours before and after procedure, 1 month after procedure)
- Late-term Hand Numbness(1 month after procedure)
- Quick Disabilities of the Arm Shoulder and Hand (DASH) Questionnaire (0-100)(24 hours before procedure and 1 month after procedure)
- Visual Analogue Scale (VAS) Scale (0-10)(24 hours after procedure)