跳至主要内容
临床试验/NCT05239013
NCT05239013Unknown早期 1 期

Safety and Tolerability of Topical Nitroglycerin to Dilate the Radial Artery Prior to Transradial Coronary Angiography

Thomas Jefferson University0 个研究点目标入组 20 人开始时间: 2022年5月1日最近更新:
适应症
干预措施
相关药物

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

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

Experimental

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)

研究者

申办方类型
Other
责任方
Sponsor

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