Nicardipine to Avoid Spasm in Trans Radial Percutaneous Coronary Intervention
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 1,500
- 试验地点
- 1
- 主要终点
- Number of Participants in which radial artery spasm occurred
研究概览
简要总结
Radial artery is the recommended route for percutaneous coronary intervention for it significantly reduces net adverse clinical events compared to the femoral approach. The success of the radial approach is therefore of a paramount importance. However, radial artery spasm (RAS) remains one of the major limitations of transradial approach (TRA) and the most frequent cause of TRA failure. Several recommendations has been issued to improve success rate when using the radial route.
In the Tunisian difficult economic context, the use of low end equipment, the unavailability of nitroglycerine and calcium antagonist verapamil, has led to the general feeling that RAS and TRA failure has subsequently increased.
The standard and only used protocol by the Tunisian interventional cardiologist, consists of administrating 1 mg isosorbide dinitrate through the arterial sheath immediately after radial arterial puncture, therefore limiting the options to prevent RAS.
Nicardipine is the only injectable calcium antagonist available in Tunisia. Its spasmolytic action on radial artery has been well demonstrated when used in CABG. However, it has been very poorly investigated in trans radial percutaneous coronary intervention.
Investigators believe that the concomitant use of nicardipine with isorbide might significantly reduce RAS and TRA failure when compared to isosorbide dinitrate only.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients scheduled for coronary intervention will be eligible for screening (coronarography or coronary angioplasty).
- •Participant is willing and is able to give informed consent for participating in the trial.
- •Male or Female, aged 18 years or above.
排除标准
- •Planned femoral approach because no radial pulse was perceived
- •Cardiogenic shock
- •Coronary intervention for ST elevation myocardial infarction during the night shift.
研究组 & 干预措施
nicardipine and isosorbide dinitrate
A Cocktail of 1 mg of Isosorbide Dinitrate associated to 1 mg of nicardipine will be put in a syringe than diluted in saline serum to have a volume of 3cc.
The obtained solution will be administered in an intra-arterial fashion via the trans-radial sheath after randomization.
干预措施: Nicardipine (Drug)
isosorbide dinitrate
Isosorbide Dinitrate: 1 mg will be diluted in saline solution as to have a 3cc volume The obtained solution will be administered in an intra-arterial fashion via the trans-radial sheath after randomization
干预措施: Nicardipine (Drug)
结局指标
主要结局
Number of Participants in which radial artery spasm occurred
时间窗: 24 hours
Significant limitation of the catheter movement perceived by the operator together with mild to severe pain in the forearm of the patient or the need of repeating vasodilator administration
次要结局
- Number of Participants in which severe radial artery spasm occurred(24 hours)
研究者
Pr. Semir Nouira
MD
University of Monastir