Impact of Donor and Recipient ST2 / IL-33 Pathway After Heart Transplantation (ISIDORE)
Impact of Donor and Recipient ST2 / IL-33 Pathway on Recipient Survival and Acute Rejection After Heart Transplantation
研究概览
地位
条件
详细说明
Soluble protein sST2 has recently become a prognostic biomarker in the context of acute myocardial infarction and chronic heart failure, and recent studies also show that sST2 is involved in acute rejection of the cardiac graft in recipients. Experimental studies confirm that the ST2 / IL-33 pathway is involved in the process leading to cardiac transplant rejection in animals. In particular, administration of IL-33 would have a positive effect on pre-clinical cardiac graft survival. No study have looked at the level of ST2 / IL-33 of the donor, with the purpose that it might reflect the condition of the transplanted heart and its initial level of Immune tolerance and maybe predict the risk of subsequent dysfunction.
In this non-interventional study, several blood samples will be taken on donors before organ procurement and on recipients prior to grafting, on day 7 and at the time of each myocardial biopsy (approximately 16 myocardial biopsies the first year). Serum level of sST2 and IL-33 will then be determined according to the ELISA method on each blood sample.
Fifty consecutive couple donors/ recipients will be included in the study. This number of subjects is calculated to detect a doubling of the donor sST2 level between the two recipient groups with 30-day mortality and without mortality (potency: 90%, alpha risk: 0.05, bilateral).
研究类型
注册 (预期的)
联系人和位置
学习地点
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Paris、法国、75013
- 招聘中
- Department of Thoracic and Cardiovascular Surgery, Cardiac Institute, Groupe Hospitalier La Pitié Salpêtrière
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接触：
- Antonella Galeone, MD, PhD
- 电话号码：0033664841652
- 邮箱：a.galeone@email.it
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
描述
Inclusion Criteria:
- Consenting recipients
- Consenting donors to organ/tissue donation for the purpose of scientific research
Exclusion Criteria:
- Non consenting recipients
- Non consenting donors to organ/tissue donation for the purpose of scientific research
- Multi-organ transplantation
学习计划
研究是如何设计的？
设计细节
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Survival
大体时间：30 days
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Compare mean donor sST2 serum levels in recipients who died at 30 days versus mean donor sST2 serum levels in recipients who survived at 30 days.
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30 days
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Survival and Rejection and IL-33
大体时间：1 year
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1 year
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Survival and Rejection and sST2
大体时间：1 year
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1 year
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合作者和调查者
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (预期的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他研究编号
- CIC-1421-16-01
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
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