NCT03562572进行中（未招募）不适用
Ischemia (FFR) Driven Complete Revascularization Versus Usual Care in Patients With Non-ST Elevation Myocardial Infarction and Multivessel Diseases: The South Limburg Myocardial Infarction Study Group The SLIM Study
Zuyderland Medisch Centrum9 个研究点 分布在 3 个国家目标入组 476 人开始时间: 2018年6月7日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 476
- 试验地点
- 9
- 主要终点
- The incidence of MACE at 12 months
研究概览
简要总结
To compare FFR guided complete revascularization during the index procedure with usual care in non-STEMI patients with multivessel disease.
详细描述
Background:
Patients with non-ST elevation myocardial infarction (non-STEMI), as compared with STEMI patients, have a higher risk profile, more often MVD and less favourable outcome. Recent studies showed that complete revascularization in STEMI patients is feasible and effective. However, there is no clear evidence regarding the role of complete coronary revascularization by PCI in patients with non-STEMI with MVD.
Objective:
To compare FFR guided complete revascularization during the index procedure with usual care in non-STEMI patients with multivessel disease.
Design:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged between 18-85 years presenting with non-STEMI according to current guidelines, who will be treated with PCI of the culprit and have at least one stenosis of >50% in a non-IRA on QCA or visual estimation of baseline angiography and judged feasible for treatment with PCI by the operator.
- •Non-IRA stenosis amenable for PCI treatment (operator's decision)
- •Signed informed consent
排除标准
- •Left main disease (stenosis > 50%)
- •Chronic total occlusion of a non-IRA
- •Indication for or previous coronary artery bypass grafting
- •Uncertain culprit lesion
- •Complicated IRA treatment, e.g. extravasation, permanent no re-flow after IRA treatment (TIMI flow 0-1) and inability to implant a stent
- •Known severe cardiac valve dysfunction that will require surgery or TAVI in the follow-up period.
- •Killip class III or IV during the completion of culprit lesion treatment.
- •Life expectancy of < 1 year.
- •Intolerance to Aspirin, Clopidogrel, Prasugrel, Ticagrelor or Heparin.
- •Gastrointestinal or genitourinary bleeding within the prior 3 months.
- •Planned elective surgical procedure necessitating interruption of thienopyridines during the first 6 months post enrolment.
- •Patients who are actively participating in another drug or device investigational study, which have not completed the primary endpoint follow-up period.
- •Pregnancy
结局指标
主要结局
The incidence of MACE at 12 months
时间窗: 12 months
MACE = The composite endpoint of all cause death, non-fatal Myocardial Infarction, any revascularisation and stroke at 12 months.
次要结局
- All-cause mortality or Myocardial infarction at 12, 24 and 36 months.(12, 24 and 36 months)
- The incidence of MACE in subgroups at 12 and 24 months.(12 and 24 months)
- Composite endpoint of Net Adverse Clinical Events (NACE) defined as composite endpoint of Cardiac death, Myocardial Infarction, any Revascularisation, Stroke and major bleeding at 12, 24 and 36 months.(12, 24 and 36 months)
- Stent thrombosis at 12, 24 and 36 months.(12, 24 and 36 months)
- Bleeding (major and minor) at 48 hours and 12 months.(48 hours and 12 months)
- Composite endpoint hospitalisation for heart failure and unstable angina pectoris at 12, 24 and 36 months.(12, 24 and 36 months)
- Any revascularisation at 12, 24 and 36 months.(12, 24 and 36 months)
- The incidence of MACE at 36 months as well as outcomes of each component of MACE at 12 and 24 and 36 months.(12, 24 and 36 months)
- Left ventricular ejection fraction at 12 and 24 and 36 month (MIBI scan, MRI or Echocardiography).(12, 24 and 36 months)
研究者
Saman Rasoul
Principal Investigator
Zuyderland Medisch Centrum
研究点 (9)
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