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临床试验/NCT03780335
NCT03780335已完成不适用

EARLY Microvascular Dysfunction Prediction Using Quantitative Flow Ratio After ST-segment Elevation MYOcardial Infarction (EARLY-MYO-QFR I)

RenJi Hospital0 个研究点目标入组 162 人开始时间: 2015年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
162
主要终点
Cardiac magnetic resonance (CMR)

研究概览

简要总结

The study intends to provide important data on whether the noval method using quantitative flow ratio could predict microvascular dysfunction.

详细描述

Microvascular dysfunction (MVD) is a serious complication of PCI, which happens frequently after STEMI and always correlates with a poor prognosis. However, precise and simplified assessment of MVD is difficult, especially in the acute phase of STEMI patients. Resent studies suggested that FFR could be overestimated when MVD exists. But whether the overestimated value of FFR caused by CMR defined MVO could reflect microcirculation function is still unclear.

This study is a retrospective study using STEMI patients with TFG 2/3 of the infarct vessel on initial angiography and presumed culprit lesion ≥50% as the population. Contrast-enhanced CMR was performed 5 days after PCI as the reference standard.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Retrospective

入排标准

性别
All
接受健康志愿者

入选标准

  • STEMI patients treated with revasculation within 12 hours from onset of symptoms to PCI time and received CMR 5 days afterwards. STEMI was defined as a combination of the following: chest pain for more than 30min, electrocardiographic (ECG) changing with ST segment elevation of >2 mm in at least 2 precordial leads and >1 mm in limb leads, and abnormal troponin levels or CKMB levels higher than twice the upper limit of normal.
  • Patients with TFG 2/3 in the initial angiography of the culprit vessel.

排除标准

  • Patients with left bundle branch block in the presenting ECG, cardiogenic shock, PCI or bypass surgery history.
  • Patients with residual stenosis <50%.
  • Patients with unqualified coronary angiographic images with problems such as ostial lesion, severe vessel tortuosity and diffuse long lesions.

结局指标

主要结局

Cardiac magnetic resonance (CMR)

时间窗: Five days after PCI

Cardiac magnetic resonance (CMR) is a non-invasive test for MVO assessing

次要结局

  • TIMI Flow Grade (TFG)(One mins after PCI)
  • TIMI Myocardial Perfusion Grade (TMPG)(One mins after PCI)

研究者

申办方类型
Other
责任方
Sponsor

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