A Randomised, Double-blind, Parallel Group, Efficacy and Safety Study of Transdermal Patch Nitroglycerin in the Prevention of Coronary Artery Spasm, During Coronary Angiography/ Angioplasty (NURSE-TTS - Nitrate Use to Obtain Radial Spasm Embarrassment)
试验速览
- 阶段
- 3 期
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Successful radial puncture
研究概览
简要总结
Transradial cardiac catheterization and percutaneous coronary intervention are increasingly being performed worldwide in elective and emergency procedures, with many centres adopting the transradial route as their first choice of arterial access. One of the most common complications encountered during transradial procedures is radial artery spasm. The aim of this study is to evaluate the Efficacy and Safety of the use of transdermal Glyceryl trinitrate patches applied to skin before cardiac catheterization to prevent the occurrence of radial artery spasm during transradial access cardiac catheterization.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female 18 -85 years old who has been admitted for scheduled coronary angiography by radial artery
排除标准
- •Prior same radial artery catheterization
- •Positive Allen test
- •Severe Hypotension (SBP<100 mmHg)
- •Pregnancy
- •Ongoing Acute Myocardial Infarction
- •Ongoing cardiogenic shock
- •Known History of Nitrates intolerance/allergy
研究组 & 干预措施
Transdermal glyceryl trinitrate patches
干预措施: Transdermal glyceryl trinitrate 10mg patches (Drug)
Transdermal placebo patches
干预措施: Placebo patches (Drug)
结局指标
主要结局
Successful radial puncture
时间窗: During radial puncture and catheterization
The success is defined by the fast radial puncture and catheterization and is measured by the time of radial catheterization
Radial Spasm occurrence
时间窗: Immediately after the end of the procedure
Radial spasm is measured by the exerting force (in Newton) removing the sheath from the patient
次要结局
- State-Trait Anxiety Inventory (STAI)(During the whole procedure)
- VRS-4 pain scale(During the whole procedure)
研究者
Fotios Oikonomou
Consultant Interventional Cardiologist - Head of Cath Lab
424 General Military Hospital