Primary FIbrinolysis and Secondary STenting Versus immEdiate Stenting in ST-segment Elevation Myocardial Infarction (FISSTEMI)-- A Prospective Randomized Trial of Stent Implantation Strategy After Thrombolytic Therapy
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 240
- 试验地点
- 1
- 主要终点
- Complete microvascular perfusion of subepicardial and myocardial tissues-TIMI flow grade 3
研究概览
简要总结
This prospective, multicenter, randomized, controlled, open-label clinical study has a target enrollment of 240 subjects. It will explore whether STEMI patients transferred to a PCI center following thrombolytic therapy and expected to have stent implantation might benefit from an alternative treatment strategy and the use of new technologies designed to improve myocardial protection throughout the medical care process.
详细描述
Eligible patients with STEMI who meet the Inclusion/Exclusion Criteria will receive thrombolytic therapy, and then be transferred to the PCI center for coronary angiography (CAG). Patients having a target vessel with TIMI grade 3 flow as shown by CAG, and and ≥ 50% angiographic stenosis after thrombus aspiration, will be randomized in a 1:1 ratio to either an immediate stenting group or a deferred stenting group. Patients assigned to the immediate stenting group will undergo appropriate stent implantation based on characteristics of the lesions. Patients assigned to the deferred stenting group will be sent back to the ward after PCI to receive standard anticoagulant and antiplatelet therapies, and the CAG will be repeated 5 to 7 days after initial intervention, followed by treatment with stent implantation.
All subjects will be recorded postoperative microcirculation perfusion and ST-segment drop of electrocardiogram and followed up by telephone or in the clinic at 1, 6, and 12 months after discharge from the hospital to obtain information including their general condition, chief complaints or discomforts, details of taking their oral medications, recent relevant test results, and to evaluate the primary endpoint, secondary endpoints.
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
盲法说明
This study is a prospective, multicenter, randomized, controlled, open-label clinical study.
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Inpatients who meet all of the following criteria can be included in the study:
- •Age: 18-75 years old;
- •A confirmed diagnosis of STEMI with symptom onset within 12 h;
- •STEMI criteria:
- •Patient has a history of chest pain/discomfort;
- •ST elevation ≥ 0.1 mV in at least two contiguous leads of an ECG on admission (> 30 minutes; ≥ 0.2 mV required for V2 and V3 ) or the development of new left bundle branch block (LBBB);
- •an increase in cardiac biomarkers (troponin, CK-MB) above the 99th percentile of the laboratory upper reference limit;
- •Time from FMC to wire crossing estimated to be > 120 min;
- •Has a target vessel with TIMI grade 3 flow shown as by CAG and ≥ 50% angiographic stenosis after thrombus aspiration;
- •Has culprit lesions identified as primary lesions;
- •Signed the written informed consent form.
排除标准
- •Patients are not eligible for enrollment if they meet any of the following criteria:
- •A contraindication to thrombolysis;
- •An estimated survival time ≤ 12 months;
- •Known heart failure of Killip class III or above, or mechanical complications such as heart rupture;
- •Known to be participating in any other clinical trial;
- •Pregnant or lactating women, or women experiencing their menstrual period;
- •Weight < 40 Kg or > 125 Kg;
- •Known allergies to drugs that are required during the study such as contrast agents, antiplatelet drugs, and anticoagulants;
- •A target vessel with TIMI grade 0-2 flow as revealed by the initial CAG;
- •Having lesions located in the LMCA or root of the LAD, or with severe multiple vessel disease.
结局指标
主要结局
Complete microvascular perfusion of subepicardial and myocardial tissues-TIMI flow grade 3
时间窗: one minute after the end of the each procedure
Complete microvascular perfusion of subepicardial and myocardial tissues: TIMI flow grade 3 and TMP grade 3 and complete ST resolution on an ECG at 60 minutes after study intervention (STR ≥ 70%). For the immediate stenting group, the TIMI flow grade will be evaluated immediately after stent implantation. For the deferred stenting group, the TIMI flow grade will be evaluated after the first and second operations.
Complete microvascular perfusion of subepicardial and myocardial tissues-complete ST resolution on an ECG
时间窗: within 60 minutes after PCI.
Complete microvascular perfusion of subepicardial and myocardial tissues: TIMI flow grade 3 and TMP grade 3 and complete ST resolution on an ECG at 60 minutes after study intervention (STR ≥ 70%). All patients will have an 18-lead ECG within 60 minutes after PCI.
Complete microvascular perfusion of subepicardial and myocardial tissues-TMP grade 3
时间窗: one minute after the end of the each procedure
Complete microvascular perfusion of subepicardial and myocardial tissues: TIMI flow grade 3 and TMP grade 3 and complete ST resolution on an ECG at 60 minutes after study intervention (STR ≥ 70%). For the immediate stenting group, the TMP grade will be evaluated immediately after stent implantation. For the deferred stenting group, the TMP grade will be evaluated after the first and second operations.
次要结局
- TIMI myocardial perfusion frame count (TMPFC)(before and after each operation)
- TIMI myocardial perfusion (TMP) grade for infarct-related arteries(one minute after the end of the each procedure)
- Corrected TIMI frame count (cTFC) for infarct-related arteries(one minute after the end of the each procedure)
- Myocardium salvage index (MSI)(five to seven days after the last intervention (prior to discharge))
- TIMI flow grade for infarct-related arteries(one minute after the end of the each procedure)
- Measurement of ST resolution on an ECG(60 minutes after PCI)
- Myocardial infarct size(five to seven days after the last intervention (prior to discharge))
- TIMI myocardial blush grade (MBG) for infarct-related arteries(one minute after the end of the each procedure)
研究者
Yu Bo
The Second Affiliated Hospital of Harbin Medical University
Harbin Medical University