Comparison of Clinical Outcomes of Intravascular Ultrasound (IVUS) -Guided and Angiography-Guided Primary Percutaneous Intervention (PCI) in Patients With Acute ST Segment Elevated Myocardial Infarction (STEMI)
试验速览
- 阶段
- 不适用
- 状态
- Available
- 发起方
- 试验地点
- 1
研究概览
简要总结
To compare the long-term clinical outcomes of IVUS-guided vs angiography-guided PCI in patients with acute STEMI
详细描述
This study is a prospective, multicenter, randomized controlled trial, led by the second hospital affiliated to zhejiang university school of medicine, A total of 10 hospitals in zhejiang province interventional cardiovascular center to participate in, plan to recruit 200 STEMI patients.
Subjects according to the proportion of 1:1 were randomly allocated to two treatment groups.(Experimental group (IVUS) steering group or control group (imaging) steering group.) Plan 10 centers in 200 men and women aged 18 and older patients, according to the American heart association and the United States The college of cardiology interventional treatment guidelines for the participants.
Each center recruiting number does not exceed 40% of the total plan recruitment.
研究设计
- 研究类型
- Expanded Access
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 (CI) Criteria: CI. Age > 18 years C
- •Onset of STEMI > 30 minutes, but < 12 hours C
- •ST segment elevation in at least 2 contiguous leads of≥ 1mm or newly developed LBBB on ECG C
- •Willing and able to provide informed consent
- •Angiographic Inclusion (AI) Criteria (visual estimate) AI
- •Having at least one infarct-related coronary artery of which
- •the Culprit lesion is suitable for stenting
- •the reference diameter of culprit vessel is ≥ 2.5 mm but ≤ 4 mm
- •the TIMI flow is ≤ 1 in culprit lesion segment prior to guide wire crossing AI
- •No excessive tortuosity and calcification in the culprit lesion segment that allowing stent implantation
排除标准
- •Clinical Exclusion (CE) Criteria CE
- •Contraindicating to any concomitant study medications CE
- •Having cardiogenic shock with hemodynamic instability CE
- •A history of bleeding diathesis or known coagulopathy CE
- •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 CE
- •Planned surgery which may cause discontinuation of ADP-receptor antagonist CE
- •Other serious illness (e.g., cancer) that may reduce life expectancy to less than 1 year CE
- •Repeated MI within 7 days of hospitalization for acute MI
- •Angiographic Exclusion (AE) Criteria (visual estimate) AE
- •Bifurcated lesion unable to identify the culprit lesion AE
- •The culprit lesion is located in the left main artery. AE
- •Diffusive lesions without distinguishable culprit lesion AE
- •Previous stent implantation in the culprit lesion segment or STEMI caused by stent thrombosis AE
- •Likely CABG procedure within 30 days