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临床试验/NCT02425358
NCT02425358已完成2 期

Timing for Intracoronary Administration of Bone Marrow Mononuclear Cells After Acute ST-elevated Myocardial Infarction: a Pilot Study

The First Affiliated Hospital of Dalian Medical University0 个研究点目标入组 104 人开始时间: 2005年2月1日最近更新:
适应症

试验速览

阶段
2 期
状态
已完成
发起方
入组人数
104
主要终点
Change of left ventricular eject factor (LVEF) from the baseline

研究概览

简要总结

Most studies on intracoronary bone marrow mononuclear cell (BMC) transplantation for acute myocardial infarction (AMI) involve treatment 3-7 days after primary percutaneous coronary intervention (PCI); however, the optimal timing is unknown. The present study assessed the therapeutic effect at different times after ST-elevation myocardial infarction (STEMI).

详细描述

On the basis of experimental studies that bone marrow mononuclear cells (BMCs) transfer in the injured tissue can promote regional myocardial perfusion and improved cardiac function, several clinical trials have shown that intracoronary bone marrow mononuclear cell (BMC) transplantation in acute myocardial infarction (AMI) patients several days after myocardial reperfusion is safe and may enhance the improvement of left ventricular ejection fraction (LVEF). The timing of BMC administration, baseline LVEF, dosage of BMC and other factors has been linked to improvement in LVEF after BMC transplantation. In our previous work, we gave BMCs within 24 hours after emergency percutaneous coronary intervention (PCI) and found that it was safe and effective . In addition, there are another report about longer time from symptom onset to BMC infusion (2-4 weeks), which also appeared effective . The timing of intracoronary stem cell administration may have a critical effect on cell engraftment and may be responsible for the various biological and functional responses to therapy. However, few studies have directly addressed the optimal timing of cell injections. Therefore, in this prospective randomized study, BMCs were given at different times (within 24 hours, 3 to 7 days, or 7 to 30 days after reperfusion) to investigate whether the timing of therapy affects the therapeutic response of AMI patients.

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 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • a history of first acute ST-elevation myocardial infarction
  • treatment with successful PCI two to twelve hours after symptom onset
  • LVEF less than 50% on angiography immediately after emergency PCI or rescue PCI

排除标准

  • previous Q-wave myocardial infarction
  • cardiogenic shock
  • severe coexisting conditions such as acute and chronic heart failure, malignant
  • arrhythmia, renal failure and severe bleeding that interfered with the ability of the
  • patient to comply with the protocol

结局指标

主要结局

Change of left ventricular eject factor (LVEF) from the baseline

时间窗: 12 months

次要结局

  • Change of left ventricular end-diastolic volume (LVESV) from the baseline(12 months)
  • Change of left ventricular end-systolic volume (LVEDV) from the baseline(12 months)
  • Change of myocardial perfusion from the baseline(12 months)

研究者

发起方
The First Affiliated Hospital of Dalian Medical University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Rchuang

Professor

The First Affiliated Hospital of Dalian Medical University

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