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临床试验/NCT01569334
NCT01569334Unknown不适用

Identification of Non Invasive Biomarkers of Immune Endothelial Injury and Repair Associated With Cardiac Allograft Vasculopathy

Assistance Publique Hopitaux De Marseille1 个研究点 分布在 1 个国家目标入组 170 人开始时间: 2011年2月最近更新:
适应症

试验速览

阶段
不适用
入组人数
170
试验地点
1
主要终点
Analysis of endothelial lesion-repair biomarkers

研究概览

简要总结

Heart transplantation is the best option for patients with end-stage heart failure. Cardiac allograft vasculopathy (CAV) is the leading cause of death following cardiac transplantation and is not managed by current therapies. Its pathogenesis traduces in an accelerated form of coronary artery disease (CAD) with similarities to atherosclerosis but also particular features of endothelial dysfunction associated to the alloimmune conflict and humoral responses toward the graft. Intravascular ultrasound (IVUS) is the validated invasive method for late CAV diagnosis, but occurs lesions are established. Identification of reliable non-invasive early endothelial injury biomarkers that reflect mechanisms of cardiac damage thus remain a major challenge to optimize therapeutic management of post transplant morbidity. Endothelial dysfunction is a central feature of both CAV and CAD and results from a desquilibrium in the balance of endothelial lesion and repair that is partly controlled by recipient immune system. Through their expression of receptors sensing antibodies (FcR CD16) and endothelial stress-induced signals (CX3CR1 fractalkine receptor and NKG2D MICA receptors), Natural Killer (NK) cells represent effector cells with unique potential to generate both humoral and innate immune injury of graft endothelium.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
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

  • Subject > 18 years at the time of the inclusion,
  • Subject having benefited from a heart transplant more than 11 months ago in the service of cardiac surgery concerned whatever is the treatment to immunosuppresseur current
  • Subject benefiting from a coronarography within the framework of their surveillance comment-Clerk's Office beyond 12 months
  • Subject having given their consent
  • Affiliated to the Social Security
  • * HTC with Cardiac allograft vasculopathy:
  • Subject with coronaropathies diagnosed by the coronarography
  • * TC without Cardiac allograft vasculopathy:
  • Subject without coronaropathies diagnosed by the coronarography
  • * untransplanted
  • Untreated Subject by immunosuppresseurs
  • Subject without antécédaent of transfusion
  • Subject without history of transplantations
  • Subject with coronaropathies diagnosed by a coronarography

排除标准

  • Presenting a contraindication to the coronarography
  • Subject refusing to practise the examination of coronarography
  • Subject reaches(affects) of a cancer other one than cutaneous
  • Subject achieves of hepatic Incapacity (ALAT and\or ASAT > 3N)

结局指标

主要结局

Analysis of endothelial lesion-repair biomarkers

时间窗: 24 MONTHS

through phenotypic and quantitative analysis of circulating endothelial progenitors subsets and (repair potential)

次要结局

  • Analysis of anti endothelial NK innate immune responses parameters(24 MONTTHS)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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