Efficacy of Intravenous Regadenoson Versus Intravenous Adenoscan® for Fractional Flow Reserve Measurements
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Comparing Measurement of Fractional Flow Reserve (FFR)
研究概览
简要总结
The purpose of this study is to demonstrate that intravenous regadenoson is equivalent to intravenous Adenoscan® for the physiological assessment of intermediate coronary lesions.
详细描述
This is a prospective open label, single center pilot trial that will evaluate regadenoson compared to Adenoscan® to be given IV in the assessment of Fractional Flow Reserve. Forty eight subjects will be enrolled and get Adenoscan® administered via IV followed by Regadenoson IV.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- 否
入选标准
- •Patients undergoing elective left heart catheterization
- •Age ≥ 18 years (female not of child bearing potential)
- •Able to provide written informed consent
排除标准
- •Contraindications to administration of either Adenoscan® or Regadenoson
- •High degree AV block, sick sinus syndrome without a functioning pacemaker
- •Symptomatic bradycardia
- •Recent STEMI (< 5 days)
- •Recent NSTEMI (<5 days) if the peak CK is > 1000 IU
- •Dipyridamole use within 24 hours
- •Adenoscan® is contraindicated (hypersensitivity to Adenoscan®, Regadenoson, or aminophylline
- •Known severe bronchoconstrictive lung disease
研究组 & 干预措施
Adenoscan
Subjects will have the FFR Measurement with IV Adenoscan®
干预措施: FFR Measurement with IV Adenoscan® then with Regadenoson (Drug)
Regadenoson
Subjects will have the FFR Measurement with IV Regadenoson
干预措施: FFR Measurement with IV Adenoscan® then with Regadenoson (Drug)
结局指标
主要结局
Comparing Measurement of Fractional Flow Reserve (FFR)
时间窗: DAY 1
For the first measurement of FFR, the subject will receive Adenoscan® by IV infusion. Then the FFR measurements will be taken. When vital signs have returned to normal, after two minutes the line will be flushed with saline. The subject will then receive Regadenoson by IV infusion and repeat FFR measurements will be recorded. The subject will be administered aminophylline and the time duration it takes to return to baseline hemodynamic will be recorded.
次要结局
- Duration to Baseline Hyperemia After Aminophylline Injection(seconds)
研究者
Robert Bober, M.D.
Director of Nuclear Cardiology
Ochsner Health System