Optical Frequency Domain Imaging-Quantified Intracoronary Thrombus Mass During Primary Percutaneous Coronary Intervention, Its Relationship With Antiplatelet Pretreatment Effect And Its Impact On Myocardial Reperfusion
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 63
- 试验地点
- 1
- 主要终点
- the volume of residual intrastent mass measured by OCT
研究概览
简要总结
The management of ST-elevation myocardial infarction in the acute phase requires an optimal antiaggregation combining aspirin and a P2Y12 inhibitor (clopidogrel, prasugrel or ticagrelor). Primary percutaneous coronary intervention must be performed within 2 hours of first medical contact. However, even with the new P2Y12 inhibitors, effective platelet inhibition which is required to inhibit the progression of intracoronary thrombus, is present only in half of the patients at 2 hours.
Optical coherence tomography (OCT) is the reference method for visualizing and quantifying intracoronary thrombus. The post-stenting intracoronary residual mass evaluated in OCT was associated with altered myocardial reperfusion indices, which were themselves associated with the prognosis of the patient. However, the determinants of this post-stenting residual mass -mostly thrombotic- remain unknown.
Measurement of platelet reactivity (expressed as P2Y12 Reaction Unit and Aspirin Reaction Unit) by simple turbidimetric tests (VerifyNow) is available in the cathlab. Enhanced platelet reactivity is reported in patients with acute coronary syndrome and represents a high-risk situation for recurrent coronary events in this setting.
The study aims to:
- to evaluate the relationship between the post-stenting residual intracoronary mass evaluated in OCT and the platelet response at the time of the PCI evaluated by Verify Now
- to confirm the impact of the residual mass measured by OCT on the EKG and angiographic myocardial reperfusion indices
- identify patients with high thrombotic risk who may require more intensive antithrombotic therapy
- identify simple biological markers associated with the residual mass measured by OCT
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •primary PCI with successful stenting for ST-elevation myocardial infarction
- •pretreated with ticagrelor, aspirin and enoxaparin
- •OCT and verifyNow performed in the acute phase
排除标准
- •stent thrombosis
- •known coagulation disorder
- •clinical instability
- •pregnancy
结局指标
主要结局
the volume of residual intrastent mass measured by OCT
时间窗: day 0
volume of the residual mass in mm3
the platelet reactivity assessed by VerifyNow
时间窗: day 0
P2Y12 and aspirin reaction units, assessed by VerifyNow
次要结局
- fibrinogen(day 0)
- albumin(day 0)
- Corrected Timi Frame count(day 0)
- angiographic pre-stenting thrombus grade(day 0)
- regression of EKG ST-segment elevation(day 0)
- Myocardial blush grade(day 0)
- troponin(day 0)