Comparison of Regadenoson (Rapiscan) and Central Intravenous Adenosine for Measurement of Fractional Flow Reserve
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- the accuracy of Regadenoson to induce maximal and steady state hyperemia
研究概览
简要总结
The aim of the study is to test the accuracy of Regadenoson to induce maximal and steady state hyperemia as compared to central venous infusion of adenosine for assessing fractional flow reserve. (adenosine is considered to be the gold standard)and to investigate the time intervals of maximum hyperemia induced by centrally and peripherally administered Regadenoson.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-80 years
- •Scheduled for invasive measurement of FFR for diagnostic and interventional purposes in proximal or mid segments of a coronary artery
排除标准
- •Severe aortic valve stenosis
- •History of severe COPD
- •Syncope or bradycardia (less than 50 beats/min)
- •Known conduction disturbances (2nd-3rd degree heart-block, sick sinus without pacemaker or long QT-syndrome)
- •Severe hypotension (RR <90 mmHg)
- •Patients in whom no access to the coronary circulation can be obtained by the femoral artery or in whom femoral access was problematic
- •Coronary anatomy not suitable for FFR measurement (extremely tortuous or calcified coronary vessels)
- •Previous coronary bypass surgery
- •Recent ST elevation myocardial infarction (<5 days)
- •Recent non-ST elevation myocardial infarction (<5 days) if the peak CK is >1000 IU
- •Inability to provide informed consent
- •Pregnancy
- •Use of methylxanthines (in the last 12 hours)
- •Use of Dipyridamol (in the last 48 hours)
研究组 & 干预措施
Regadenoson central - peripheral
First bolus regadenoson administered central, second bolus administered peripheral
干预措施: Regadenoson central - peripheral (Drug)
Regadenoson central - peripheral
First bolus regadenoson administered central, second bolus administered peripheral
干预措施: Adenosine (Drug)
Regadenoson peripheral - central
First bolus regadenoson administered peripheral, second bolus administered central
干预措施: Regadenoson peripheral - central (Drug)
Regadenoson peripheral - central
First bolus regadenoson administered peripheral, second bolus administered central
干预措施: Adenosine (Drug)
Regadenoson central - central
First bolus regadenoson administered central, second bolus administered central
干预措施: Regadenoson central -central (Drug)
Regadenoson central - central
First bolus regadenoson administered central, second bolus administered central
干预措施: Adenosine (Drug)
Regadenoson peripheral - peripheral
First bolus regadenoson administered peripheral, second bolus administered peripheral
干预措施: Regadenoson peripheral - peripheral (Drug)
Regadenoson peripheral - peripheral
First bolus regadenoson administered peripheral, second bolus administered peripheral
干预措施: Adenosine (Drug)
结局指标
主要结局
the accuracy of Regadenoson to induce maximal and steady state hyperemia
时间窗: participants will be followed up during hospital stay, an expected average of 1 day
To test the accuracy of Regadenoson to induce maximal and steady state hyperemia as compared to central venous infusion of adenosine for assessing fractional flow reserve. (adenosine is considered to be the gold standard).
次要结局
- time intervals of maximum hyperemia(participants will be followed up during hospital stay, an expected average of 1 day)
研究者
Lokien van Nunen
MD
Catharina Ziekenhuis Eindhoven