EUCTR2015-003260-37-GB进行中（未招募）不适用
Can Ivabradine attenuate post-revascularisation microcirculatory dysfunction in flow limiting coronary artery disease? - Ivabradine and PCI related microcirculatory dysfunction
iverpool Heart and Chest Hospital0 个研究点开始时间: 2016年3月21日最近更新:
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试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1.1.Symptoms of Angina Pectoris
- •2.Angiographic evidence of epicardial coronary artery stenosis referred for PCI
- •3.Flow limiting lesion (Fractional Flow Reserve =0.80) in one of following locations (as defined in SYNTAX trial):
- •a.Proximal or mid left anterior descending artery (LAD)
- •b.Proximal or mid dominant right coronary artery (RCA)
- •c.Proximal left circumflex artery (LCx) or 1ST Obtuse marginal Vessel
- •4.Existing beta blocker prescription
- •5.Echocardiogram performed within preceding 12 months
- •6.Patient consent
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 70
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 10
排除标准
- •1.1.Previous myocardial infarction (MI) in target vessel myocardial territory or any MI in preceding 12 months (defined by patient history, ECG changes and evidence of regional wall motion abnormalities on echocardiography)
- •2.FFR>0.80 in target vessel at time of procedure
- •3.Requirement for Multi-vessel intervention in a single procedure
- •4.Any chronic total occlusion (100% epicardial occlusion) on angiography
- •5.Distal coronary artery stenosis or that affecting non-dominant RCA
- •6.Heart Rate <60 bpm at inclusion (assessed by 12 lead ECG after minimum 10 minutes rest period)
- •7.Any rhythm other than sinus rhythm
- •8.Sick sinus syndrome or high grade atrio-ventricular block
- •9.Permanent Pacemaker in situ
- •10.Congenital QT Syndrome
- •11.Intolerance or allergy to beta-blockers
- •12.Intolerance to Ivabradine
- •13.Additional (other than angina pectoris) indication for beta-blocker treatment e.g. ventricular tachycardia
- •14.Concurrent required use of rate-limiting drugs other than beta-blockers
- •15.The necessity of combination therapy with Ivabradine and bisoprolol to achieve heart rate control
- •16.Contraindication to Magnetic Resonance Imaging or IV adenosine
- •17.Severe impairment of renal function (eGFR<30ml/min)
- •18.Severe Liver Disease (Any worse than Grade A by Child-Pugh Classification)
研究者
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