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临床试验/NCT02510703
NCT02510703已完成不适用

Assessment of Coronary Endothelial Function in Diabetic Patients With Acute Coronary Syndrome Using 15O-water Positron Emission Tomography

University Hospital, Caen2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2011年3月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
40
试验地点
2
主要终点
Comparison of quantitative variables coronary endothelial function in PET according to the presence or absence of type 2 diabetes in patients investigated with the waning of a first heart attack

研究概览

简要总结

Type 2 diabetes is associated with early and diffuse abnormalities of endothelial function, especially in the coronary arteries, which are a factor of poor prognosis. Following acute coronary syndrome, the endothelial function abnormalities usually persist for several weeks before regressing. Their persistence 6-8 weeks after myocardial infarction is a poor prognostic factor. Investigators assume that global abnormalities of endothelial function in patients with diabetes may be additive with segmental abnormalities in revascularized myocardium, and contribute to worsening the prognosis in these patients. Furthermore, there is no published data showing any relationship between calcium score and endothelial function abnormalities in these patients. The investigators seek a relationship between calcium score and persistence of abnormalities of coronary endothelial function in these patients.

The main objective of this study was to compare coronary endothelial function by quantitative method (TEP at 15O-H2O) in diabetic patients and nondiabetic following acute coronary syndrome.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
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 a first myocardial infarction, type 2 diabetic or non-diabetic treated by angioplasty in acute phase (TIMI 3)
  • Myocardial viability test before discharge
  • Age over 18 years
  • Informed Consent dated and signed by the patient
  • Written and spoken French
  • Beneficiary of social security insurance

排除标准

  • Hypertension> 160/90 mmHg despite medical treatment
  • Lack of effective revascularization in acute phase of myocardial infarction (TIMI grade <3)
  • Significant three-vessel coronary artery disease (> 70% stenosis in the other two coronary arteries); occlusion of a coronary artery; schedule revascularization (percutaneous or surgical); left main coronary artery stenosis
  • Previous history of myocardial infarction
  • Mechanical complication (mitral regurgitation, ventricular septal rupture, left ventricular free wall rupture)
  • Heart failure
  • No myocardial viability test before discharge, for whatever reason
  • Type 1 diabetes
  • Pregnant and / or lactating
  • Age under 18 years or guardianship

结局指标

主要结局

Comparison of quantitative variables coronary endothelial function in PET according to the presence or absence of type 2 diabetes in patients investigated with the waning of a first heart attack

时间窗: baseline

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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