STaged Interventional Strategies for Acute ST-seGment Elevation Myocardial Infarction Patient With Multi-vessel Disease （STAGED）
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,586
- 试验地点
- 1
- 主要终点
- Major adverse cardiac event (MACE), defined as cardiovascular death, MI, ischemia-driven revasculrization (for both culprit and non-culprit lesions).
研究概览
简要总结
An investigator-initiated, randomized, multicenter, two-arm, open-label study of consecutive patients presenting with STEMI and MVD Objectives: The present study aimed to investigate the difference in major adverse cardiac event (MACE) between Early staged PCI versus Late staged PCI groups among patients with ST-segment elevated myocardial infarction （STEMI and multi-vessel Disease（MVD) who underwent primary PCI using DES for culprit lesions.
Background: In patients with STEMI with MVD who underwent primary PCI, complete revascularization for non-culprit lesions has proved to reduce the risk of cardiovascular death and myocardial infarction. However, the ideal timing point for staged PCI for nonculprit lesions remains uncertain.
详细描述
A total of 1586 subjects with STEMI who met inclusion criteria and had no any exclusion criterion will be randomized (at a 1:1 ratio) to Early staged PCI group and Late staged PCI group. After successful percutaneous coronary intervention for culprit lesion, staged PCI for all non-culprit vessel with significant lesion defined at least 80% diameter stenosis by visual estimation and accompanied by a QFR measurement of less than or equal to 0.80 will be performed. Patients will be ranmized to the following groups at 1:1 ratio:
- Patients randomized to the in-hospital staged PCI (Early group) will undergo PCI for all significant non-culprit lesions at 7±3 days after revascularization of the culprit lesion.
- Patients randomized to out-hospital staged complete revascularization (Late group) will undergo PCI for all significant non-culprit lesions at 30±15 days after primary PCI.
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
- Double (Care Provider, Outcomes Assessor)
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
- •Provision of informed consent prior to any study specific procedures;
- •Established indication to PPCI according to the guidelines of American Heart Association and American College of Cardiology;
- •Spontaneous acute STEMI (patients presenting within 24 hours of symptom onset) with MVD after successful revascularization of the culprit artery;
- •De novo coronary lesion,
- •TIMI Flow 3 ( Cases with TIMI flow 2 need to perform angiographic again in 24h ensured TIMI flow 3 for enrolling case )after revascularization of the culprit artery, residual stenosis ≤20% and no coronary dissection greater than or equal to type C leading to (threatening) vessel closure.
- •At least one non-culprit coronary stenosis ≥ 80% and accompanied by QFR ≤0.8 in a vessel with a lumen diameter ≥2.5;
排除标准
- •Age <18 yr and >80 yr;
- •Cardiac shock, multiple organ failure, cerebral hemorrhage, severe aortic stenosis and myocardial infarction complications(cardiac rupture, ventricular septal rupture and papillary muscle rupture);
- •Killip classification >3, cardiognic shock, shore-infarction of culprit artery after emergency PCI in 24 hours;
- •Previous documented allergic reaction to drug and device of this study;
- •Planned major surgery within 6 weeks in which impact DAPT;
- •Participation in another clinical study, interfering with this protocol Uncertain;
- •Life expectancy < 1 year;
- •Any condition likely to interfere with study processes including follow-up visits or increase of risk accessed by researcher.
结局指标
主要结局
Major adverse cardiac event (MACE), defined as cardiovascular death, MI, ischemia-driven revasculrization (for both culprit and non-culprit lesions).
时间窗: 12 months
The difference in MACE will be calculated from randomisation to 12 months.
次要结局
- Rate of contrast-induced nephropathy（CIN）(12 months)
- All-cause death(12 months)
- Cardiovascular death(12 months)
- Heart failure-induced rehospitalization(12 months)
- Stroke(12month)
- Rate of contrast-induced nephropathy（CIN）(12 months)
- Myocardial Infarction (MI)(12 months)
- Revascularization(12 months)
研究者
Yan Wang
Prof
Xiamen Cardiovascular Hospital, Xiamen University