Topical Nitroglycerine Treatment for Radial Artery Spasm Prevention
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Radial Artery Spasm
研究概览
简要总结
The primary objective of the study is to determine the role of transdermal vasodilators as an adjunct to parenteral vasodilators in reducing radial artery spasm, improving patient comfort, and post procedure radial artery patency during transradial coronary angiograms and interventions. The study hypothesis is that transdermal vasodilators will increase radial artery size and reduce radial artery spasm as well as improve patient comfort and post procedure radial artery patency. This is a single-center, double-blind, randomized, placebo-controlled study comparing the effect of transdermal preparations of lidocaine + nitroglycerine and lidocaine + placebo on radial artery spasm in patients undergoing transdermal coronary angiograms. Prior to the procedure, each patient will be randomized into either the control arm, lidocaine + placebo, or study arm, lidocaine + nitroglycerine.
详细描述
Background:
Vascular access site complications (VASC) during cardiac catheterizations are significantly higher in femoral access compared to radial access. Main disadvantage in radial access is the restriction in size of catheters as well as incidence of radial artery spasm. Radial spasm is identified by pain in the forearm aggravated by movement of the catheter/sheath; difficulty in manipulating the catheter; loss of radial pulse or damping of radial arterial pressure. Tortuosity and loops in upper extremity arterial tree could mimic some findings of radial artery spasm. Incidence of radial spasm has been reported to range between 4% and 20%. Risk factors include smaller radial artery diameter, atherosclerotic lesions, entrance of guidewires into side branches, vessel tortuosity, larger arterial sheath diameters, procedure duration, female sex, younger age, lower BMI, Diabetes, number of catheters used, volume of contrast, unsuccessful access at first attempt, fear and anxiety. Mean size of radial artery is reported at 2.44 mm. Women and persons of south Asian descent tend to have smaller radial arteries with means of 1.91mm and 2.00 mm respectively. Outer diameters of commonly used 5 French (5F) and 6 French (6F) sheaths are 2.16 mm and 2.62 mm respectively. Ratio of radial artery to sheath size affects post-procedural radial artery flow.
Transdermal vasodilators prior to vascular access would increase chance for successful arterial access in first attempt and increase radial artery to sheath size ratio both of which should have additive benefit to intraarterial (IA) vasodilators in reducing spasm. Transdermal lidocaine would reduce pain during subcutaneous lidocaine, which can further ameliorate the risk of radial artery spasm. Use of transdermal nitroglycerine has been shown to safely increase radial artery size without significant hypotension.
Aim:
To study the role of transdermal vasodilators as an adjunct to parenteral vasodilators, in reducing radial artery spasm and improving patient comfort and post procedure radial artery patency during radial coronary angiograms and interventions.
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
- Double (Participant, Investigator)
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
- •Age: 18 years or older
- •Radial artery catheterization
排除标准
- •Hypersensitivity or contraindication to lidocaine
- •Hypersensitivity or contraindication to nitroglycerine
- •Recent use of phosphodiesterase 5 inhibitors (<24 hours after sildenafil or vardenafil; <48 hours after tadalafil)
- •Baseline weak radial pulse (0 or 1+)
- •Baseline hypotension SBP < 100 mmHg at the time of enrollment
- •Dizziness or light-headedness at the time of enrollment
- •Severe Aortic Stenosis or Hypertrophic obstructive cardiomyopathy
- •Previous unknown bypass grafts or known left internal mammary graft
- •Chest pain within 6 hours of IP administration
- •More than 2 episodes of chest pain within 24 hours prior to IP administration
- •Use of sublingual, transdermal, or intravenous nitroglycerine within 6 hours prior to IP administration
- •Likely need for use of nitroglycerine for non-study indication
- •Narcotic or sedative within 4 hours of enrollment
- •Women who are suspected or known to be pregnant or breastfeeding
研究组 & 干预措施
Study
40 mg of topical lidocaine and 30 mg of topical nitroglycerine is applied to the wrist overlying radial pulse (centered approximately 1 inch proximal to the radial styloid process) at least 60 minutes before arterial puncture. Immediately prior to sterile preparation of access site, transdermal preparation will be removed in the cath lab.
干预措施: Topical Nitroglycerine (Drug)
Study
40 mg of topical lidocaine and 30 mg of topical nitroglycerine is applied to the wrist overlying radial pulse (centered approximately 1 inch proximal to the radial styloid process) at least 60 minutes before arterial puncture. Immediately prior to sterile preparation of access site, transdermal preparation will be removed in the cath lab.
干预措施: Topical Lidocaine (Drug)
Control
40 mg of topical lidocaine and placebo is applied to the wrist overlying radial pulse (centered approximately 1 inch proximal to the radial styloid process) at least 60 minutes before arterial puncture. Immediately prior to sterile preparation of access site, transdermal preparation will be removed in the cath lab.
干预措施: Topical Lidocaine (Drug)
结局指标
主要结局
Radial Artery Spasm
时间窗: Intraprocedural: From procedure start to application of radial band. Approximate time 30 to 90 minutes.
Incidence of radial artery spasm indicated by a Radial artery spasm score of 1 or more. Radial artery spasm score is sum of: 1. Intraprocedural pain in the forearm aggravated by movement of the catheter/sheath - Absent :0; Present:1 2. Difficulty in manipulating the catheter- Absence :0; Present:1 3. Difficulty with sheath removal: Absent: 0; Present:1 4. Additional use of intraarterial nitroglycerine or verapamil after the initial vasodilator cocktail- No:0; Yes:1
次要结局
- Change in Radial Artery Dimension Measured in mm^2.(Application of nitroglycerine / placebo until prior to arterial puncture. Approximate 60 to 120 minutes)
- Number of Patients With Procedural Failure(Intraprocedural: From procedure start to application of radial band. Approximate time 30 to 90 minutes.)
- Patient Discomfort or Pain During Procedure (Visual Analog Scale 0-10)(Intraprocedural: From procedure start to application of radial band. Approximate time 30 to 90 minutes.)
- Radial Pulse at End of Procedure(At the end of transradial cardiac catheterization after sheath removal)
研究者
Prabhakaran Gopalakrishnan
Prabhakaran Gopalakrishnan, MD
Aultman Health Foundation