Instantaneous Wave-free Ratio Guided Multi-vessel revascularizatiOn During Percutaneous Coronary intervEntion for Acute myocaRdial iNfarction (iMODERN)
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 1,146
- 试验地点
- 1
- 主要终点
- Composite end point of Major Adverse Cardiac Events
研究概览
简要总结
In patients with acute ST-elevation myocardial infarction (STEMI), 40-60% have multi-vessel disease with an increased cardiovascular morbidity and mortality. Although it is not recommended to revascularize noninfarct lesions during the acute intervention, recent investigations suggest the opposite and show improved outcome after direct revascularization of noninfarct lesions. It is undesirable to risk procedure-related complications by treating noninfarct lesions without impaired flow. It is currently unknown whether pressure guided revascularization of noninfarct lesions in the acute phase improves outcome compared to the current guidelines.
The iMODERN trial aims to compare an iFR-guided intervention of noninfarct lesions during the acute intervention with a deferred stress perfusion CMR-guided strategy during the outpatient follow-up, to determine the optimal therapeutic approach for STEMI patients with multivessel lesions.
详细描述
Study design:
The study is a prospective, randomized controlled, multicentre study.
Study population:
The research population will be recruited from the general patient population presenting with an acute STEMI. Patients treated with successful primary PCI and one or more additional significant coronary lesions in another coronary artery will be enrolled in the study. A total of 1,146 consecutive patients will be included.
Intervention:
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 years and older
- •Clinical presentation of STEMI and successful primary PCI within 12 hours from onset of symptoms
- •One or more other, noninfarct coronary artery lesions of >50% stenosis and feasible to be revascularized (i.e., minimal diameter 2mm)
排除标准
- •History of ST-elevation myocardial infarction or coronary artery bypass graft
- •Hemodynamic instability, respiratory failure, Kilips class ≥III
- •Known GFR<30 ml/min
- •Known contra-indications for stress CMR (e.g.: severe claustrophobia, metal implants, severe renal failure, severe astma)
- •Refusal or inability to provide informed consent
- •Life expectancy due to noncardiovascular co-morbidity of less than 12 months
- •Chronic total occlusion
- •Left main stem stenosis (>50%)
- •Residual noninfarct lesion in infarct coronary artery
- •Complex noninfarct target lesions
- •Pregnancy
研究组 & 干预措施
Deferred CMR-guided revascularization
Decision to treat the nonculprit coronary stenosis if perfusion defect visible in corresponding coronary territory as visualized on stress perfusion CMR imaging
干预措施: CMR (Diagnostic Test)
Active iFR-guided revascularization
Decision to treat the nonculprit coronary stenosis if there is a significant pressure drop over the stenosis, as measured by intracoronary iFR assessment
干预措施: iFR (Diagnostic Test)
结局指标
主要结局
Composite end point of Major Adverse Cardiac Events
时间窗: 3 years
All-cause death, recurrent myocardial infarction and hospitalization for heart failure
次要结局
- Composite end point of Major Adverse Cardiac Events(6 months, 12 months, and 5 years)
- Cardiac death(6 months, 12 months, 3 years, and 5 years)
- Myocardial infarction(6 months, 12 months, 3 years, and 5 years)
- Stroke(6 months, 12 months, 3 years, and 5 years)
- Transient ischemic attack(6 months, 12 months, 3 years, and 5 years)
- Major bleeding(6 months, 12 months, 3 years, and 5 years)
- Unstable angina(6 months, 12 months, 3 years, and 5 years)
- Revascularization(6 months, 12 months, 3 years, and 5 years)
- Coronary angiography(6 months, 12 months, 3 years, and 5 years)
- Stent thrombosis(6 months, 12 months, 3 years, and 5 years)
- Target lesion failure(6 months, 12 months, 3 years, and 5 years)
- Quality of life(From enrolment to 6 and 12 months, 3 and 5 years follow-up)
- Cost effectiveness analysis(6 and 12 months, 3 and 5 years)