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临床试验/NCT03264859
NCT03264859Unknown不适用

Neutrophil Gelatinase-associated Lipocalin (NGAL) and Its Association With the No-reflow Phenomenon in ST-elevation Myocardial Infarction

Sheba Medical Center1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2017年9月15日最近更新:
适应症

试验速览

阶段
不适用
入组人数
100
试验地点
1
主要终点
No-reflow phenomenon after STEMI

研究概览

简要总结

The aim of this study is to investigate the association between NGAL plasma levels in ST-elevation myocardial infarction and the no-reflow phenomenon, adverse events during hospitalization and at 30-day follow-up.

详细描述

Neutrophil Gelatinase-associated Lipocalin (NGAL) is a acute phase protein which is elevated in conditions like acute kidney injury and myocardial infarction. When a coronary artery is occluded, detrimental changes occur in myocardial vessels. After relief of the occlusion, blood flow to the heart may still be impeded, a phenomenon known as "no-reflow". Data is lacking on factors associated with early detection of patients at risk for this phenomenon, and early stratification of this group seems vital since the no-reflow phenomenon is associated with worse outcomes. The investigators hypothesized that there might be an association between higher NGAL levels and the occurrence of no-flow findings, and that NGAL might serve as a marker of worse prognosis in this population. The investigators also hypothesized that NGAL levels might serve as a marker of early acute kidney injury and that there might be specific patterns of NGAL levels over time in different subsets of patients. The aim of the study is to determine the association between NGAL levels at admission and during the first days after a ST-elevation myocardial infarction, the occurrence of the no-reflow phenomenon, the extent of myocardial damage ascertained by cardiac imaging techniques (echocardiography and cardiac resonance imaging). Data regarding patients' clinical, laboratory, electrocardiogram, coronary angiography and percutaneous coronary intervention, in-hospital and 30-day follow-up after discharge will be recorded.

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

  • Patients > 18 years old presenting with ST-elevation myocardial infarction and undergoing urgent coronary angiography with or without PCI.
  • Signed informed consent to participate in the study.

排除标准

  • Inability to sign written informed consent.
  • Chronic renal failure (eGFR < 30 ml/min/1.73m2).

结局指标

主要结局

No-reflow phenomenon after STEMI

时间窗: During hospitalization

No-reflow phenomenon as defined by electrocardiographic, angiographic and cardiac magnetic resonance imaging criteria.

次要结局

  • In-hospital MACE(major adverse cardiac events)(Average day 5 of hospitalization and before discharge)
  • The need for renal replacement therapy after STEMI(In-hospital (usually 5 days))
  • 30-day MACE(30-day follow-up)
  • Serial creatinine level(On admission and at fixed time intervals (first 3 hours after admission, 12 hours, 24 hours and every 24 hours or before if indicated))
  • Recurrent hospitalization(30 days)

研究者

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

Dr. Shlomi Matetzky

Head, Intensive Care Care Unit

Sheba Medical Center

研究点 (1)

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