Distal vs. Proximal Radial Artery Access for Cardiac Catheterization and Intervention
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 300
- 试验地点
- 2
- 主要终点
- Quick Disabilities of the Arm Shoulder and Hand (DASH) Questionnaire Score (0-100)
研究概览
简要总结
This single-center, prospective, randomized study will evaluate distal radial artery (dRA) vs. proximal radial artery access (pRA) in regards to hand function and radial artery occlusion.
详细描述
Primary objective is to evaluate hand function following distal radial artery access compared to proximal artery access in patients undergoing cardiac catheterization.
Hand function will be assessed by:
- QuickDASH questionnaire
- Hand grip test
- Thumb forefinger pinch test utilizing a pinch gauge
Secondary objectives: Vascular access success rates, hematoma, bleeding, complications of vascular access and radial artery occlusion.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 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
- 否
入选标准
- •Age ≥ 18 years.
- •The distal and proximal 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.
- •Patient on therapeutic oral anticoagulation.
- •Very large hand/wrist anatomy that will preclude using the available hemostatic radial bands.
- •Enrolment in another study that competes or interferes with this study.
- •Poor clinical condition like cardiogenic shock, which prohibits pre- and post-procedural function tests.
- •Subject with planned complex PCI or procedure necessitating multiple intervention.
- •Any other condition or co-morbidity 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.
- •History of stroke with residual deficit that affects hand function.
- •Previous radial artery catheterization within 1 year.
结局指标
主要结局
Quick Disabilities of the Arm Shoulder and Hand (DASH) Questionnaire Score (0-100)
时间窗: 1 year
Hand function questionnaire, Range: 0 (no disability) to 100 (most severe disability)
Thumb and Forefinger Pinch Strength Test
时间窗: 1 year
Hand function: Thumb and forefinger pinch strength (kg)
Hand Grip Strength Test
时间窗: 1 month
Hand grip strength test (kg)
次要结局
- Radial Artery Occlusion(1 year)
- Re-intervention Using the Radial Artery(1 year)