Safety and Tolerability of Topical Nitroglycerin to Dilate the Radial Artery Prior to Transradial Coronary Angiography
试验速览
- 阶段
- 早期 1 期
- 入组人数
- 20
- 主要终点
- Change in systolic blood pressure
研究概览
简要总结
Phase 1, single-center, open-label clinical study to assess the safety and efficacy of topical nitroglycerin on dilation of the radial artery. Subjects will receive nitroglycerin ointment prior to scheduled PCI and radial artery measurements will be performed to determine mean increase in radial artery diameter at several time points. There will be 20 subjects enrolled in this study.
详细描述
This is a phase I study evaluating the safety, tolerability, and efficacy of topical nitroglycerin prior to percutaneous coronary intervention (PCI). Although the ultimate plan is to evaluate this intervention vs placebo, it is important to first determine whether topical nitroglycerin not only is safe for patients, but whether it effectively dilates the radial artery. Given that patients who receive topical nitroglycerin applied to the chest for other reasons (angina or acute coronary syndrome, hypertension, etc) have reported headaches and/or have experienced decreased blood pressure, it is important to determine whether these noted side effects are present when nitroglycerin ointment is applied to the arm. Prior to initiating any study procedures, we will perform a Barbeau test to determine normal blood flow through the radial artery and collateral circulation from the ulnar artery through the palmar arch. After the ointment is applied, we will also be measuring the dimensions of the radial artery for the degree of dilation in order to determine whether topical nitroglycerin is indeed a possible method for increasing the rate of PCI performed using the transradial approach (TRA).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 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
- 是
入选标准
- •Scheduled to undergo PCI using TRA in the cardiac catheterization laboratory
排除标准
- •Known nitrate allergy
- •Baseline hypotension with systolic blood pressure <90mmHg
- •Absence of radial artery blood flow in one or both arms
- •Presence or history of liver, rheumatologic, or chronic kidney disease
- •Current treatment with any vasodilator therapy (eg. Sildenafil)
- •Radial artery catheterization <30 days prior to enrollment
- •Active site infection
- •AV-fistula or prior radial artery harvest for bypass surgery
- •Abnormal Barbeau test
研究组 & 干预措施
Treatment Group
Subjects who receive the intervention
干预措施: Nitroglycerin ointment (Drug)
结局指标
主要结局
Change in systolic blood pressure
时间窗: 45 minutes
Changes in blood pressure measured by upper arm cuff pressure
Incidence of headache
时间窗: 45 minutes
Rate and severity of headache, determined by subject-reported symptoms.
Hematoma
时间窗: 45 minutes
Incidence of forearm hematoma development
次要结局
- Radial artery dilation(45 minutes)
- Transradial conversions to transfemoral approach(45 minutes)
- Punctures required(45 minutes)
