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临床试验/NCT02517255
NCT02517255Unknown不适用

Salvage of Myocardial Infarction Documented by Magnetic Resonance Imaging in Patients Undergoing Rescue Percutaneous Coronary Intervention

Federal University of São Paulo2 个研究点 分布在 1 个国家目标入组 72 人开始时间: 2015年7月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
72
试验地点
2
主要终点
Microvascular obstruction - percentage of left ventricular mass displaying a lack of contrast uptake in the core of an area showing delayed enhancement.

研究概览

简要总结

Atherosclerotic disease is responsible for one third of all deaths annually and is a major cause of comorbidities. While atherosclerosis is by itself a benign disease, it often leads to complications such as acute myocardial infarction with ST-segment elevation. Rescue angioplasty is indicated if thrombolytic therapy fails. However, the benefits in reducing mortality and the amount of myocardium effectively saved are not well established. The development of new tools, including cardiac magnetic resonance imaging to identify myocardial area at risk and infarcted increased diagnostic accuracy. However, unlike the context of primary angioplasty, little is known about the relation between coronary epicardial and microvascular flow after rescue angioplasty and myocardial salvage. The objective of this study is to evaluate whether there is a relation between these flows and myocardial salvage identified by Magnetic Resonance Imaging (MRI). At the end of this research, the investigators hope to contribute to a better understanding of coronary flow and its relation to the amount of heart muscle saved after rescue angioplasty. This is an important information that can help understand which cases benefit most from rescue angioplasty.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

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

  • Patients with ST segment elevation myocardial infarction (STEMI) who underwent Thrombolysis within 12 hours of chest pain and present clinical and/or electrocardiogram (EKG) signs of failed thrombolysis with indication of rescue percutaneous coronary intervention (PCI).

排除标准

  • Patients with contraindication to Cardiac Magnetic Resonance Imaging (MRI) (pacemaker, aneurysm clip, claustrophobia, hemodynamic instability, etc).
  • Allergy or contraindication to Gadolinium.
  • Contraindication to dual anti-platelet therapy.

研究组 & 干预措施

Cardiac Magnetic Resonance Imaging

Experimental

Cardiac MRI will be performed within 7 days of rescue percutaneous coronary intervention (PCI) and after 3 and 6 months.

干预措施: Cardiac Magnetic Resonance Imaging (Device)

结局指标

主要结局

Microvascular obstruction - percentage of left ventricular mass displaying a lack of contrast uptake in the core of an area showing delayed enhancement.

时间窗: 6 months

次要结局

  • Infarct size - percentage of left ventricular mass with signal intensity 2 standard deviations above the mean signal obtained in the remote non-infarcted myocardium.(6 months)

研究者

发起方
Federal University of São Paulo
申办方类型
Other
责任方
Principal Investigator
主要研究者

Luiz Fernando Ybarra

MD

Federal University of São Paulo

研究点 (2)

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