跳至主要内容
临床试验/NCT02788396
NCT02788396已完成不适用

The Impact of Post Stenting Balloon Dilatation on Coronary Microcirculation in ST Segment Elevation Myocardial Infarction (STEMI) Patients Undergoing Primary Percutaneous Coronary Intervention (PPCI)

Mid and South Essex NHS Foundation Trust1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2016年5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
30
试验地点
1
主要终点
Delta index of microcirculatory resistance (dIMR)

研究概览

简要总结

This study aims to assess the impact of NC balloon post-dilatation on coronary microcirculation in patients with ST segment elevation myocardial infarction (STEMI) undergoing primary percutaneous coronary intervention (PPCI).

详细描述

Suboptimal stent deployment can lead to future stent failure. Thus, optimising stent deployment with non-compliant balloons (NC balloon) post dilatation (PD) at high pressures is an established strategy. In the context of ST segment elevation myocardial infarction (STEMI), PD has been correlated anecdotally with the no reflow phenomenon.

This study aims to determine the impact of stent post-dilation (PD) with NC balloons at high pressures on coronary microcirculation during PPCI by measuring the index of microcirculatory resistance (IMR) pre and post stent post-dilatation. Pre and post PD, an optical coherence tomography (OCT) study will be performed to assess stent deployment and identify parameters that predict the changes in IMR.

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

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Delta index of microcirculatory resistance (dIMR)

时间窗: index procedure

Delta index of microcirculatory resistance (dIMR) \[dΙΜΡ = IMR post post-dilation (post IMR) - IMR pre post-dilation (pre IMR)\]

次要结局

  • Stent edge dissections(index procedure)
  • Stent expansion(index procedure)
  • Minimum stent area (MSA)(index procedure)
  • Stent mal-apposition(index procedure)
  • Intra-stent plaque protrusion and thrombus(index procedure)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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