The Role of Oral Verapamil in Preventing Radial Spasm During Transradial Angiography
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Number of Participants With Clinical Radial Artery Spasm (RAS)
研究概览
简要总结
Coronary angiography (CAG) is an invasive imaging method performed to determine the degree of coronary artery disease. Radial artery spasm (RAS) is one of the most common complications during coronary angiography performed via the transradial approach, causing patient discomfort or sometimes interrupting the procedure. There are many studies on RAS, and various pharmacoagents administered intravenously (intraarterial) to prevent RAS have been described. However, there is limited data in the literature regarding oral pharmacoagents that will prevent this complication. In our study, the preventive effect of Verapamil, given orally 2 hours before coronary angiography, on radial artery spasm will be investigated.
详细描述
Transradial access (TRA) has emerged as the preferred modality for vascular access in coronary interventions worldwide, prompting growing interest in its potential applications across other interventional specialties, especially in neurovascular procedures. Radial artery spasm (RAS) remains the most common complication of TRA, often causing procedural difficulties, patient discomfort, and an increased risk of access site crossover. The incidence of radial artery spasm reported in the literature varies widely, with estimates ranging from 4% to over 51.3%, influenced by factors such as definitions, patient selection, and the operator's experience.
After puncturing the radial artery (Puncture-induced RAS) and inserting the sheath-but before administering intra-arterial spasmolytics-local discomfort and pain may trigger a sympathetic vasoconstrictive response, potentially leading to the onset of RAS.
A previous study has stated that preventing RAS is more effective than treating it after it has been established. In this context, we will conduct a randomized controlled trial to evaluate the efficacy of 120 mg of oral verapamil administered two hours before radial artery puncture in reducing the incidence of radial artery spasm (RAS)
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
- None
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who undergo daily coronary angiography
- •Whose Allen test is normal.
- •Must be able to swallow tablets
排除标准
- •Allen test results are distorted,
- •No pulse in the radial artery,
- •Patients who have previously undergone radial angiography and whose hemodynamics are compromised will be excluded from the study.
- •Patients with known contraindications to verapamil (significant aortic stenosis, heart rate <50/min, high-grade atrioventricular block, myocardial infarction) complicated with cardiogenic shock, or left ventricular ejection fraction <35%).
研究组 & 干预措施
Placebo
No other vasodilating drug such as nitrate will be given intravenously
干预措施: Verapamil (Drug)
Verapamil
Verapamil will be given orally at least 2 hours before angiography
干预措施: Verapamil (Drug)
结局指标
主要结局
Number of Participants With Clinical Radial Artery Spasm (RAS)
时间窗: During the coronary angiography procedure (up to 2 hours from sheath insertion)
Clinical RAS defined as presence of at least 2 of the following: (1) forearm pain ≥ 4/10, (2) pain during catheter manipulation, (3) catheter movement restriction, (4) pain during sheath removal, (5) difficulty in sheath removal.
Number of Participants With Ultrasonographically Confirmed Radial Artery Spasm (Ultrasonographic RAS)
时间窗: During the procedure, immediately after catheterization (within 2 hours)
Radial artery spasm (RAS) was defined as luminal narrowing of ≥50% as measured by ultrasonography at the access site.
次要结局
- Number of Participants With Procedural Success(During the procedure (from sheath insertion to procedure completion))
- Mean Volume of Contrast Media Used (mL) (mL)(During the procedure (from sheath insertion to procedure completion))
- Mean of the Dose Area Product (DAP)(During the procedure (from sheath insertion to procedure completion))
- Mean of the Fluoroscopy Time(During the procedure (from sheath insertion to procedure completion))
研究者
Sefa Sural
MEDICAL DOKTOR( Principal investigator)
Mersin Medicalpark Hastanesi