A Prospective, Open Label, Multicenter and Randomized Study of Clinical Outcomes of Intravascular Ultrasound -Guided and Angiography-Guided Primary Percutaneous Intervention in Patients With Acute ST Segment Elevated Myocardial Infarction
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Major adverse cardiac event (MACE) rate
研究概览
简要总结
To examine the impact of IVUS guidance on clinical outcomes in the patient with Acute ST Segment Elevated Myocardial Infarction.
详细描述
Intravascular ultrasound (IVUS) has been increasingly used as a guide for percutaneous coronary intervention (PCI) during elective as well as emergent clinical scenario. Recent small number randomized studies, large scale registries as well as meta-analysis have consistently demonstrated advantages of IVUS-guidance over angiography-guide alone with respect to the lower incident of death, myocardial infarction and target vessel revascularization.
There are sparse data available on the clinical impact of IVUS-guided PCI in the setting of acute myocardial infarction (AMI) and its use remains a matter of controversy as shown by previous studies. This study is to examine the impact of IVUS guidance on clinical outcomes in the patient with Acute ST Segment Elevated Myocardial Infarction (STEMI).
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical inclusion criteria:
- •Age > 18 years
- •Onset of STEMI > 30 minutes, but < 12 hours
- •ST segment elevation in at least 2 contiguous leads of≥ 1mm or newly developed LBBB on ECG
- •Willing and able to provide informed consent
- •Angiographic inclusion criteria:
- •Having at least one infarct-related coronary artery, of which (1) the Culprit lesion is suitable for stenting (2) the reference diameter of culprit vessel is ≥ 2.5 mm but ≤ 4 mm (3) the TIMI flow is ≤ 1 in culprit lesion segment prior to guide wire crossing
- •No excessive tortuosity and calcification in the culprit lesion segment that allowing stent implantation
排除标准
- •Clinical exclusion criteria:
- •Contraindicating to any concomitant study medications
- •Having cardiogenic shock with hemodynamic instability
- •A history of bleeding diathesis or known coagulopathy
- •A history of cerebrovascular accident (CVA) or transient ischemic attack (TIA) within the past 6 months; or a history of intracranial tumor, aneurysm or arteriovenous malformations; or a history of active peptic ulcer or active gastrointestinal (GI) bleeding within the past 2 months; or planned major procedure within 6 weeks; or known platelet count < 100,000 /mm3 or Hb < 10 g/dL
- •Planned surgery which may cause discontinuation of ADP-receptor antagonist
- •Other serious illness (e.g., cancer) that may reduce life expectancy to less than 1 year
- •Repeated MI within 7 days of hospitalization for acute MI
- •Anigographic Exclusion Criteria:
- •Bifurcated lesion unable to identify the culprit lesion
- •The culprit lesion is located in the left main artery
- •Diffusive lesions without distinguishable culprit lesion
- •Previous stent implantation in the culprit lesion segment or STEMI caused by stent thrombosis
- •Likely CABG procedure within 30 days
- •Renal failure requiring or during dialysis
研究组 & 干预措施
IVUS-guided PCI
Percutaneous intervention under IVUS-guidance
干预措施: IVUS-guided PCI (Procedure)
Angiography-guided PCI
Percutaneous intervention under angiograhy-guidance only
干预措施: Angiography-guided PCI (Procedure)
结局指标
主要结局
Major adverse cardiac event (MACE) rate
时间窗: 1 year
Defined as cardiac death, myocardial infarction (MI, Q-wave and non-Q-wave) and target vessel revascularization (TVR)
次要结局
- TVR rate(2-3 years)
- Target lesion failure (TLF) rate(2-3 years)
- MI (Q-wave and non-Q-wave) rat(2-3 years)
- Cardiac death rate(2-3 years)
- Non-cardiac death rate(2-3 years)
- Target vessel failure (TVF) rate(2-3 years)
- MACE rate(2-3 years)
- Target lesion revascularization (TLR) rate(2-3 years)
- All death (cardiac and non-cardiovascular) rate(2-3 years)
- Stent Thrombosis (ST) rate (ARC definite/probable)(2-3 years)