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临床试验/NCT02258620
NCT02258620已完成不适用

Prevention and Comparison of Different Forms of Administration of Nitrates in the Risk of Radial Spasm During Coronary Angiography.

Brugmann University Hospital1 个研究点 分布在 1 个国家目标入组 442 人开始时间: 2013年6月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
442
试验地点
1
主要终点
Radial artery diameter

研究概览

简要总结

The radial approach for a coronary angiography is currently adopted by several centers because of its simplicity. The radial artery spasm is the main inconvenient. Nitrates in intra-arterial have been widely studied in prevention of this spasm. No studies have compared the different routes of administration of nitrates as a patch and a continuous intravenous injection.

详细描述

The radial approach is favored for coronary angiography due of several advantages: reduction of local bleeding risk, even in the most hemorragiparic situations, decreased downtime and time reduction of hospitalization, improved patient ulterior comfort. However, this approach is subject to an immediate major complication that is the radial artery spasm (RAS) which, according to the criteria used, has an average incidence of 30%. The administration of a vasodilator just before coronary angiography procedure enables an increase of the radial artery diameter and thus a decrease of friction probes. Theoretically this prevents the occurrence of the RAS.

The literature re-counts several vasodilator product tests (DN calcic blocker, magnesium sulfate, alpha-adrenergic antagonist ...) and various routes of administration (direct intravenous route (IV), subcutaneous injected route, direct intra-arterial route (IA)). Overall intra-arterial DN appears to be more efficient. The downside is a brief, painful thermal sensation but intense and notably unpleasant. IV injection is better tolerated but it was a direct injection and without proof of its superiority over IA. The para-radial subcutaneous injection has only been studied to facilitate access to the radial artery. The investigators randomized study compares, for the first time, the effectiveness of the transdermal administration of trinitrine (D) and continuous intravenous of dinitrate isosorbide (V) to dinitrate isosorbide intraarterial (A) standard.

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

入选标准

  • Patients > 18 ans.
  • Patients with hemodynamic stability.
  • Patients informed consent was signed by each individual. The study obtained approval from the local ethics committee.

排除标准

  • 'Test d'Allen' negative
  • Pregnancy.
  • Hemodynamic Instability : PAS < 100 mmHg, FC > 100 bpm, tachycardia uncontrollable.
  • Allergy of nitrates.

研究组 & 干预措施

dinitrate isosorbide (intra arterial)

Experimental

dinitrate isosorbide 5 mg by direct administration intra arterial

干预措施: dinitrate isosorbide (Drug)

dinitrate isosorbide (intra venous)

Experimental

dinitrate isosorbide by continuous intra venous injection (1 à 5 mg/h)

干预措施: dinitrate isosorbide (Drug)

nitroglycerine (transdermic)

Experimental

nitroglycerine dermal patch15 mg/24h soit 67,2 mg/21 cm2

干预措施: nitroglycerine (Drug)

结局指标

主要结局

Radial artery diameter

时间窗: Day of administration

With the help of an arterial doppler, measure of the radial artery diameter after injection of dinitrate isosorbide at the beginning and at the end of the procedure (objective measure)

Probe friction

时间窗: Day of administration

Probe friction, as experienced by the operator (subjective measure)

Pain

时间窗: Day of administration

Pain felt by the patient in the forearm (subjective measure)

Radial artery occlusion

时间窗: 3 months post procedure

Evaluation of the radial artery occlusion 3 months post procedure

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

José Castro

Chef de Clinique

Brugmann University Hospital

研究点 (1)

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