Topical Nitroglycerin Prior to Trans-radial Coronary Angiography: a Phase 2, Randomized Controlled Trial
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 256
- 主要终点
- Crossover rate
研究概览
简要总结
Phase 2, single-center, randomized, blinded clinical study to assess the safety and efficacy of topical nitroglycerin on ease of TRA during scheduled PCI. We will compare topical nitroglycerin to placebo applied prior to planned, non-urgent PCI to determine if nitroglycerin is associated with decreased number of arterial puncture attempts made, decreased time to radial access, and lower crossover rate to TFA. Subjects will be randomized to receive either topical nitroglycerin ointment or placebo prior to scheduled PCI. There will be 256 subjects enrolled in this study with 1:1 randomization.
详细描述
Percutaneous coronary intervention (PCI) procedures performed by entering the radial artery, or the transradial approach (TRA), is associated with reduced vascular access site complications, bleeding, and length of hospital stay, as well as greater patient satisfaction when compared to the transfemoral approach. One of the major challenges to a successful TRA remains the small size of the radial artery. The potential need for larger catheters during PCI has been one factor limiting broader adoption of TRA and a common reason for crossover from TRA to femoral access intraprocedurally. Additionally, multiple unsuccessful attempts to access the radial artery leads to unnecessary bleeding and may lead to severe arterial vasospasms. Nitroglycerin, a vasodilator, is available in a topical form and may be used prior to PCI to dilate the radial artery and potentially increase the rate of successful TRA.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 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
- 是
入选标准
- •Male or non-pregnant female > 18 years of age at the time of consent
- •Scheduled to undergo PCI using TRA in the cardiac catheterization laboratory
- •Able to provide informed consent with capacity, given in English.
- •Exclusion Criteria
- •Patients with any of the following characteristics or conditions will not be included in the study:
- •Known nitrate allergy
- •Allergy to CeraVe Moisturizing lotion
- •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
排除标准
- 未提供
研究组 & 干预措施
Placebo arm
Subject will get placebo
干预措施: Placebo (Drug)
Nitro arm
Subject will get Nitrobid
干预措施: NitroBid (Drug)
结局指标
主要结局
Crossover rate
时间窗: 1 year
• Evaluate number of attempts needed prior to successful radial artery cannulation and need for conversion to transfemoral approach
次要结局
未报告次要终点