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临床试验/NCT02220023
NCT02220023已完成早期 1 期

Dynamic Assessment of Right Ventricular Function With Inhaled Nitric Oxide During Cardiac MRI

Vanderbilt University1 个研究点 分布在 1 个国家目标入组 17 人开始时间: 2014年7月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
早期 1 期
状态
已完成
入组人数
17
试验地点
1
主要终点
Right ventricular ejection fraction (RVEF) before and after inhaled nitric oxide exposure

研究概览

简要总结

The purpose of the study is to measure RV ejection fraction (RVEF), pulmonary flow, and pulmonary perfusion before and after exposure to inhaled nitric oxide in patients with pulmonary arterial hypertension (PAH) who are known to be vasodilator-responsive based on invasive catheterization as well as healthy subjects. Measurements will also be made after high flow oxygen alone to test the relative vasodilatory effect of oxygen and NO. The investigators hypothesize is that inhaled nitric oxide during cardiac MRI can be used to measure dynamic changes in RV-pulmonary vascular function in patients with vasodilator-responsive PAH.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
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

  • Patients age 18 or older of the Vanderbilt Center for Pulmonary Vascular Disease. Vasodilator-responsive patients will be identified based on prior response to inhaled nitric oxide during invasive right heart catheterization
  • Healthy subjects age 18 or older not known to have cardiopulmonary disease

排除标准

  • Standard conventional contraindications for cardiac magnetic resonance (CMR) imaging
  • Allergy or contraindication to Magnevist (gadopentetate dimeglumine) contrast
  • Concurrent intravenous epoprostenol infusion in whom performance of CMR is cumbersome
  • Pregnant women

研究组 & 干预措施

Nitric Oxide

Experimental

40 ppm, one time administration, inhaled.

干预措施: INOmax Inhalation (Drug)

结局指标

主要结局

Right ventricular ejection fraction (RVEF) before and after inhaled nitric oxide exposure

时间窗: At time of procedure

次要结局

  • Pulmonary transit time(At baseline, after 4 minutes high flow oxygen, after 4 minutes high flow oxygen plus nitric oxide)
  • Pulmonary flow(Baseline, after 4 minutes high flow oxygen, after 4 minutes high flow oxygen plus nitric oxide)
  • Pulmonary perfusion(Baseline, after 4 minutes of high flow oxygen, after 4 minutes of high flow oxygen plus nitric oxide)
  • Estimates of pulmonary vascular resistance(At Baseline, after 4 minutes of high flow oxygen, after 4 minutes of high flow oxygen plus nitric oxide)
  • Pulmonary artery compliance(At baseline, after 4 minutes high flow oxygen, after 4 minutes high flow oxygen plus nitric oxide)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Evan Brittain

Assistant Professor

Vanderbilt University

研究点 (1)

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