Thrombus Aspiration in ThrOmbus Containing culpRiT Lesions in Non-ST-Elevation Myocardial Infarction (TATORT-NSTEMI)
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 400
- 试验地点
- 7
- 主要终点
- Extent of late microvascular obstruction assessed by cardiac magnetic resonance imaging (CMR)
研究概览
简要总结
Whereas thrombus aspiration in patients with ST-elevation myocardial infarction (STEMI) is recommended by current guidelines, there are insufficient data to unequivocally support thrombectomy in patients with non-STEMI (NSTEMI). The Thrombus Aspiration in ThrOmbus containing culpRiT lesions in Non-ST-Elevation Myocardial Infarction (TATORT-NSTEMI) trial is a 400 patient, prospective, controlled, multicenter, randomized, open-label trial. The hypothesis is that under the background of early revascularization, adjunctive thrombectomy in comparison to conventional percutaneous coronary intervention (PCI) alone leads to less microvascular obstruction (MO) assessed by cardiac magnetic resonance imaging (CMR) in patients with NSTEMI. Patients will be randomized in a 1:1 fashion to one of the two treatment arms. The primary endpoint is the extent of MO assessed by CMR. Secondary endpoints include infarct size and myocardial salvage assessed by CMR, enzymatic infarct size as well as angiographic parameters, such as Thrombolysis in Myocardial Infarction-flow post-PCI and myocardial blush grade. Furthermore, clinical endpoints including death, myocardial reinfarction, target vessel revascularization and new congestive heart failure will be recorded at 6 and 12 months. Safety will be assessed by bleeding and stroke. In summary, the TATORT-NSTEMI trial has been designed to test the hypothesis that thrombectomy will improve myocardial perfusion in patients with NSTEMI and relevant thrombus burden in the culprit vessel reperfused by early 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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ischemic symptoms such as angina pectoris >20 minutes
- •occurrence of last symptoms <72 h before randomization
- •cardiac troponin T or I levels above the 99th percentile
- •culprit lesion containing thrombus (TIMI-thrombus grade 2-5 within the lesion) and intended early PCI
排除标准
- •cardiogenic shock
- •no identifiable culprit lesion or a TIMI-thrombus grade <2
- •coronary morphology ineligible for thrombectomy (e.g. very tortuous vessels, severe calcification)
- •indication for acute bypass surgery
- •age <18 and >90 years
- •contraindications for treatment with heparin, aspirin or thienopyridines
- •pregnancy
- •current participation in another clinical study
- •co-morbidity with limited life expectancy <6 months
- •contraindications to CMR at study entry
结局指标
主要结局
Extent of late microvascular obstruction assessed by cardiac magnetic resonance imaging (CMR)
时间窗: CMR performed within day 1 to 4 after randomization
次要结局
- Myocardial salvage assessed by cardiac magnetic resonance imaging (CMR)(CMR performed within day 1 to 4 after randomization)
- Troponin T(24 and 48 hours after randomization)
- Left ventricular ejection fraction assessed by cardiac magnetic resonance imaging (CMR)(CMR performed within day 1 to 4 after randomization)
- Thrombolysis in Myocardial Infarction (TIMI)-flow post-PCI(Immediately after percutaneous coronary intervention)
- Combined clinical endpoint(Follow-up performed at 6, 12 and approximately 60 months after randomization)
- Assessment of quality of life(6, 12 and approximately 60 months after randomization)
- Myocardial blush grade(Immediately after percutaneous coronary intervention)
- Infarct size assessed by cardiac magnetic resonance imaging (CMR)(CMR performed within day 1 to 4 after randomization)
- Stroke and bleeding(Participants will be followed for the duration of hospital stay (an expected average of 5 days))
研究者
Holger Thiele
Co-Director, Department of Internal Medicine/Cardiology, Heart Center Leipzig, University of Leipzig, Germany
University of Leipzig