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临床试验/NCT00237471
NCT00237471终止4 期

Impact of Tight Glycaemic Control With Insulin on Novel Vascular Disease Risk Factors and Myocardial Function and Perfusion in Acute Myocardial Infarction Patients With Hyperglycaemia

Melbourne Health2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2005年10月最近更新:
适应症
相关药物

试验速览

阶段
4 期
状态
终止
入组人数
40
试验地点
2
主要终点
Difference in the change in wall motion score index between admission, day 3-5 and after 3 months in the two treatment arms.

研究概览

简要总结

To determine whether tight glycaemic control with insulin improves myocardial function and myocardial perfusion (measured by myocardial contrast echocardiography) and novel vascular risk factors in patients with acute myocardial infarction and hyperglycaemia.

详细描述

We will randomise patients with acute myocardial infarction and blood glucose levels (BGLs) >=10mmol/L within 24 hours of pain onset, to either tight glucose control (aiming BGLs 4.5 - 7mmol/L) with an insulin infusion (for 24 hours) followed by subcutaneous insulin or standard control (BGL 6 - 12mmol/L) without the use of an insulin infusion. Serial myocardial contrast echocardiography will measure changes in myocardial perfusion and function from baseline to 3 months between each group. We will also measure changes in inflammatory and endothelial markers over this time to see whether tight glucose control improves these surrogate endpoints.

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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age >=18years
  • Acute Myocardial Infarction
  • Blood Glucose Level >=10mmol/L
  • Wall motion abnormality on baseline echocardiogram

排除标准

  • Active infection/inflammation
  • Cardiac shunt
  • Cognitive Impairment
  • Insulin allergy

结局指标

主要结局

Difference in the change in wall motion score index between admission, day 3-5 and after 3 months in the two treatment arms.

次要结局

  • Changes in inflammatory/endothelial markers and myocardial perfusion from admission, day 3-5 and after 3 months between the two treatment arms

研究者

申办方类型
Other

研究点 (2)

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