Prevention of Radial Artery Occlusion After Transradial Access Using Nitroglycerin
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 2,040
- 试验地点
- 3
- 主要终点
- Radial Artery Occlusion
研究概览
简要总结
The radial approach for a coronary angiography has became popular in several centers because of its simplicity and fewer complications. The radial artery occlusion (RAO) is the main inconvenient and impose a limitation of future use of the radial artery as an access site for catheterization in the future. Several strategies have been used to decrease the incidence of RAO (heparin, patent hemostasis, etc). Nitrates in intra-arterial have been widely studied in prevention of this spasm. Current data show that nitroglycerin intra-arterial at the end of the procedure reduce the incidence of RAO. The hypothesis that use of nitroglycerin at the start of catheterization would have the same effect was not tested.
详细描述
Transradial access (TRA) has been increasingly adopted for diagnostic and interventional cardiovascular procedures in many centers worldwide. This is largely driven by the evidence supporting an unequivocal reduction in access site-related complications associated with TRA compared with transfemoral access, as well as reduction in cost and increased patient comfort. The radial artery occlusion (RAO) is the main inconvenient and impose a limitation of future use of the radial artery as an access site for catheterization in the future. RAO is the most commun complication of transradial access, and its incidence continues to reach up to 12%.
Nitrates in intra-arterial have been widely studied in prevention of this spasm. Nitroglycerin binds to the surface of endothelial cells and undergoes two chemical reductions to form nitric oxide (NO). The nitric oxide then moves out of the endothelial cell and into an adjacent smooth muscle cell, where it promotes the formation of cyclic guanosine monophosphate (cGMP), which then promotes muscle relaxation. Current data show that nitroglycerin intra-arterial at the end of the procedure reduce the incidence of radial artery occlusion.
A big sheath to artery size ratio could reduce the incidence of RAO, so the main objective of this study is to evaluate whether administration of nitroglycerin at the start of a transradial procedure may preserve the patency of the radial artery; as well, confirm if nitroglycerin administration just before sheet removal helps to keep the radial artery patency.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 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
- •Indication for cardiac catheterization;
- •Suitable candidates for transradial approach;
- •Use of 5 or 6 French sheath in the procedure;
- •Signed informed consent.
排除标准
- •Unable to tolerate nitrates or known allergy to nitrates;
- •Use of any nitrate, by any route of administration, up to 1 hour before the procedure;
- •ST-segment elevation acute myocardial infarction patients during the first 12 hours of sympton onset;
- •Intubated patients (on mechanical ventilation);
- •Complications before or during procedure (cardiac arrest, pulmonary edema, cardiogenic shock, stroke);
- •Prior inclusion in this trial.
研究组 & 干预措施
Placebo I/Placebo II
0,9% Saline 10 mL was given intra-arterially through the sheath at the start of a transradial procedure (right after sheath placement) and 0,9% Saline 10 mL was given intra-arterially through the sheath at the end of procedure (just before sheath removal).
干预措施: Placebo I (Drug)
Placebo I/Placebo II
0,9% Saline 10 mL was given intra-arterially through the sheath at the start of a transradial procedure (right after sheath placement) and 0,9% Saline 10 mL was given intra-arterially through the sheath at the end of procedure (just before sheath removal).
干预措施: Placebo II (Drug)
Nitroglycerin I/Placebo II
500 microgram of Nitroglycerin (in 10 mL saline) was given intra-arterially through the sheath at the start of a transradial procedure (right after sheath placement) and 0,9% Saline 10 mL was given intra-arterially through the sheath at the end of procedure (just before sheath removal).
干预措施: Nitroglycerin I (Drug)
Nitroglycerin I/Placebo II
500 microgram of Nitroglycerin (in 10 mL saline) was given intra-arterially through the sheath at the start of a transradial procedure (right after sheath placement) and 0,9% Saline 10 mL was given intra-arterially through the sheath at the end of procedure (just before sheath removal).
干预措施: Placebo II (Drug)
Placebo I /Nitroglycerin II
0,9% Saline 10 mL was given intra-arterially through the sheath at the start of a transradial procedure (right after sheath placement) and 500 microgram of Nitroglycerin (in 10 mL saline) was given intra-arterially through the sheath at the end of procedure (just before sheath removal).
干预措施: Placebo I (Drug)
Placebo I /Nitroglycerin II
0,9% Saline 10 mL was given intra-arterially through the sheath at the start of a transradial procedure (right after sheath placement) and 500 microgram of Nitroglycerin (in 10 mL saline) was given intra-arterially through the sheath at the end of procedure (just before sheath removal).
干预措施: Nitroglycerin II (Drug)
Nitroglycerin I /Nitroglycerin II
500 microgram of Nitroglycerin (in 10 mL saline) was given intra-arterially through the sheath at the start of a transradial procedure (right after sheath placement) and 500 microgram of Nitroglycerin (in 10 mL saline) was given intra-arterially through the sheath at the end of procedure (just before sheath removal).
干预措施: Nitroglycerin I (Drug)
Nitroglycerin I /Nitroglycerin II
500 microgram of Nitroglycerin (in 10 mL saline) was given intra-arterially through the sheath at the start of a transradial procedure (right after sheath placement) and 500 microgram of Nitroglycerin (in 10 mL saline) was given intra-arterially through the sheath at the end of procedure (just before sheath removal).
干预措施: Nitroglycerin II (Drug)
结局指标
主要结局
Radial Artery Occlusion
时间窗: 2 to 24 hours after procedure
Incidence of radial artery occlusion as confirmed by absence of antegrade flow in vascular doppler ultrasound
次要结局
- Late Radial Artery Occlusion(30 days after procedure)
- Pain Assessment(up to 24 hours after procedure)
- Spasm (Operator Evaluation)(During the realization of the procedure)
- Procedure Duration(Duration of the procedure)
- Radiation Exposure(During the procedure)
研究者
Roberto Léo da Silva
Intervencional cardiologist
Instituto de Cardiologia de Santa Catarina