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临床试验/NCT05160311
NCT05160311Unknown不适用

Percutaneous Revascularization in Infarction With Late Presentation and Absence of Viability: Effects on Left Ventricular Remodeling and Contractility

Instituto Dante Pazzanese de Cardiologia1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2021年8月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
入组人数
70
试验地点
1
主要终点
Reverse myocardial remodeling after late recanalization in patients without viability

研究概览

简要总结

The purpose of this study is to evaluate whether late recanalization in patients with ST elevation myocardial infarction (STEMI) without Viability on Cardiovascular Magnetic Resonance Image (MRI) can reduce the reverse remodeling through the reduction of the End Systolic Volume (ESV) at 6 months.

详细描述

The purpose of this study is to evaluate whether late recanalization in patients with ST elevation myocardial infarction (STEMI) without Viability on Cardiovascular Magnetic Resonance can reduce the reverse remodeling through the reduction of the End Systolic Volume (ESV) at 6 months and through the improvement in segmental contractility of infarcted related artery at MRI.

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
None

入排标准

年龄范围
18 Years 至 80 Years(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

研究组 & 干预措施

Optimized Medical Treatment (OMT)

Other

The patient considered non-viable by MRI and randomized to Optimized Medical Treatment (OMT) will be treated according to Optimized Medical Treatment guidelines for Coronary Artery Disease (CAD)

干预措施: Optimized Medical Treatment (OMT) (Drug)

Angioplasty (PCI) and Optimized Medical Treatment (OMT)

Experimental

The patient considered non-viable and randomized to Coronary Angioplasty will be treated with drug-eluting stent (PCI) and Optimized Medical Treatment (OMT)

干预措施: Optimized Medical Treatment (OMT) (Drug)

Angioplasty (PCI) and Optimized Medical Treatment (OMT)

Experimental

The patient considered non-viable and randomized to Coronary Angioplasty will be treated with drug-eluting stent (PCI) and Optimized Medical Treatment (OMT)

干预措施: Drug Eluting Stent (DES) Coronary Angioplasty (Device)

结局指标

主要结局

Reverse myocardial remodeling after late recanalization in patients without viability

时间窗: 6 months

Evaluate reverse remodeling after late recanalization in patients without viability measuring End Systolic Volume (ESV) by MRI

次要结局

  • Assessement of Myocardial contractility(6 months)
  • Unplanned revascularization (Ischemia Driven and Not Ischemia Driven)(6 months)
  • Stroke Event(6 months)
  • Assessement of Left Ventricle Ejection Fraction (LVEF)(6 months)
  • Cardiovascular Death(6 months)
  • Evaluate Quality of Life(6 months)
  • Acute MI Event(6 months)
  • Cardiovascular-Related Hospitalization(6 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Barbara Porto Valente

Cardiology Physician

Instituto Dante Pazzanese de Cardiologia

研究点 (1)

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