NCT01236807已完成不适用
MR INFORM - a Randomized Non-inferiority Multicenter Trial Comparing MR Perfusion Imaging and Fractional Flow Reserve (FFR) to Guide Management of Patients With Stable Coronary Artery Disease
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 915
- 试验地点
- 1
- 主要终点
- Occurence of major adverse cardiac events (MACE)
研究概览
简要总结
The purpose of this study is to determine if MR Perfusion Imaging is non-inferior to coronary angiography with measurement of Fractional Flow Reserve (FFR) in guiding management of patients with stable chest pain.
- All patients will undergo an MR Perfusion Imaging test.
- Further management will be guided by the result of the cardiac MRI in half of the patients (chosen by random).
- The other half will undergo coronary angiography with measurement of FFR. The result of this test alone will guide their further management. The result of the initial MR Perfusion test will not be available to the treating doctors of this group.
- All patients will receive optimal medical therapy (OMT)
- All patients will undergo follow-up to find out if they have any relevant heart related events.
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
- Single (Outcomes Assessor)
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
- •Angina pectoris CCS class II and III and either
- •≥2 cardiovascular risk factors
- •or positive exercise treadmill test
- •Signed written informed consent
- •age: at least 18 years
排除标准
- •contraindication to MR
- •contraindication to adenosine infusion
- •inability to lie supine for 60 minutes
- •previous Coronary Artery Bypass Grafts
- •revascularization within the previous 6 months
- •cardiac arrhythmias (atrial fibrillation, >20 ectopic beats/min)
- •poor renal function (eGFR <30ml/min)
- •body weight > 140kg or waist perimeter > 95cm
- •known allergy to contrast media
研究组 & 干预措施
MR Inform
Active Comparator
Management guided by the result of the MR perfusion scan. Possible intervention: coronary artery revascularization.
干预措施: MR perfusion guidance (Procedure)
FFR Inform
Active Comparator
Management guided by the result of FFR measurement. Possible intervention: coronary artery revascularization.
干预措施: FFR guidance (Procedure)
结局指标
主要结局
Occurence of major adverse cardiac events (MACE)
时间窗: 1year
Composite of all cause death, myocardial infarction and repeat revascularisation.
次要结局
- changes in LV volumes and function(1 year)
- Individual MACE(1 year)
- Other adverse events(1 year)
- Course of symptoms (angina, breathlessness)(1 year)
- Cost comparison(1 year)
研究者
Eike Nagel
Global Chief Investigator
King's College London
研究点 (1)
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