PRESERVE Radial: A PRospEctive Randomized Clinical Study Comparing Radial ArtERy Intimal Hyperplasia Following Distal Vs. ForEarm TransRadial Arterial Access for Coronary Angiography
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 64
- 试验地点
- 2
- 主要终点
- Radial artery intimal medial thickness following dTRA and fTRA
研究概览
简要总结
Prospective randomized non-blinded study to determine degree of vessel trauma and adverse remodeling of the proximal forearm radial artery following distal radial artery access (dTRA) for cardiac catheterization compared to standard forearm transradial access (fTRA).
详细描述
To determine degree of vessel trauma and adverse remodeling of the proximal forearm radial artery, using ultrahigh resolution (55 MHz) ultrasound, following distal radial artery access (dTRA) for cardiac catheterization compared to standard forearm transradial access (fTRA) at 90 days post-procedure. Secondary outcome measures will include metrics of procedural success at 24 hours, as well as functional assessment of pain and motor strength of the ipsilateral upper extremity at 90 days post-procedure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 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
- 是
入选标准
- •Consecutive patients undergoing elective and non-emergent TR LHC and/or PCI at the INOVA Heart and Vascular Institute
- •Able to provide informed consent.
- •Patients willing to complete a 90day post PCI radial artery ultrasound.
排除标准
- •Patients with previous cannulation of both the right and left forearm RA's for coronary angiography and/or PCI. In patients with prior cannulation of one RA, the contralateral arm may be used for this study.
- •Patients who are not willing to undergo the necessary follow-up ultrasound examinations.
- •ST elevation myocardial infarction or other emergent PCI
- •Inability to provide informed consent
结局指标
主要结局
Radial artery intimal medial thickness following dTRA and fTRA
时间窗: 90 days post-cardiac catheterization.
Intimal medial thickness (mm) of the forearm radial artery followed dTRA and fTRA as assessed using ultrahigh resolution 55 MHz ultrasound probe at 90 days post cardiac catheterization.
次要结局
- Duration of hemostasis(24 hours post-cardiac catheterization)
- Radial artery trauma followed dTRA and fTRA(90 days post-cardiac catheterization)
- Number of cannulation attempts(24 hours post-cardiac catheterization)
- Percutaneous Coronary Intervention Success(24 hours post-cardiac catheterization)
- Functional assessment of the ipsilateral upper extremity following dTRA and fTRA(90 days post-cardiac catheterization)
- Radial artery access time(24 hours post-cardiac catheterization)
- Access site crossover(24 hours post-cardiac catheterization)
- Total procedural time(24 hours post-cardiac catheterization)
- Incidence of hematomas(24 hours post-cardiac catheterization)
- Coronary dissection(24 hours post-cardiac catheterization)
- Myocardial infarction requiring revascularization(24 hours post-cardiac catheterization)
研究者
Dr. Wayne B. Batchelor M.D.
Director of Interventional Cardiology, Inova Heart and Vascular Institute
Inova Health Care Services