EARLY Microvascular Dysfunction Assessment Using Quantitative Flow Ratio After ST-segment Elevation MYOcardial Infarction (EARLY-MYO-QFR II)
试验速览
- 阶段
- 不适用
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Cardiac magnetic resonance (CMR)
研究概览
简要总结
The study intends to provide new data on whether the noval method using quantitative flow ratio could assess microvascular dysfunction based on the previous study EARLY-MYO-QFR-I.
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 microvascular obstruction (MVO) could reflect microvascular function is still unclear.
In the previous study EARLY-MYO-QFR-I, we have demonstrated that the relationship between Contrast-enhanced CMR defined MVO and QFR. While angiography images were collected on a retrospectively manner, and the study population were selected (STEMI patients with spontaneously recanalized culprit vessel before PCI) to verify our hypothesis.
This phase of study would be a prospective study. We tend to created a new study population by a temporary artificial stenosis inside the stent by partially inflating a balloon catheter during pharmacologic hyperemia in STEMI patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- Single (Investigator)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
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.
- •Stents were implanted whenever technically possible.
- •TFG 2/3 after PCI.
排除标准
- •Patients with left bundle branch block in the presenting ECG, cardiogenic shock, previous PCI or bypass surgery, previous AMI history.
- •Patients with trouble in partially inflating a balloon catheter during pharmacologic hyperemia.
- •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 minutes after PCI)
- TIMI Myocardial Perfusion Grade (TMPG)(One minutes after PCI)
- ST-segment resolution (STR)(90 minutes after PCI)