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临床试验/NCT00208884
NCT00208884终止不适用

Terminal Graft Failure: A Combined Pathologic and Clinical Study

Emory University1 个研究点 分布在 1 个国家目标入组 19 人开始时间: 2003年10月最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
19
试验地点
1

研究概览

简要总结

One of the risks associated with heart transplantation is failure of the graft. A graft is where the new heart is attached to the original vessels in the body. Approximately 10% of children suffer graft failure which, leads to heart failure and possible death. The problem is that we do not know some of the causes of graft failure thus, it is difficult to diagnose early and treat. Due to graft failure, lots of children are placed back on the transplant list and receive another new heart.

In this study, we plan to perform a retrospective chart review looking to see if we can correlate graft failure with a problem with the vessels called coronary allograft vasculopathy or rejection. In order to do this, we will collect data from patient's charts that have been diagnosed with graft failure and compare their clinical presentation/data to pathology reports of the explanted hearts from these children. Explanted hearts are the old transplanted hearts that are removed in order to put a new heart into the body. Explanted hearts at our institution are always sent to pathology for analysis thus it will be quite easy to perform this review.

详细描述

The objectives are to describe the pathology findings from the examination of the explanted heart and correlate them with clinical variables such as catheterization data.

Children's Healthcare of Atlanta performs approximately 12-15 heart transplants a year. To date, there have been 19 re-transplantations for late graft failure at Children's. The pathologic and clinical records of these 19 patients will be studied. All data collected will be entered into a database for future analysis.

Data Collection

A retrospective review of standard pathology findings from the examination of the explanted hearts will be conducted in order to determine the following:

  1. Evidence of CAV (coronary allograft vasculopathy)
  2. Evidence of Endocardial fibroelastosis
  3. Evidence of Rejection (acute and chronic)
  4. Evidence of Myocardial infarction
  5. Evidence of Fibrosis
  6. Evidence of Fatty infiltration

研究设计

研究类型
Observational
时间视角
Retrospective

入排标准

性别
All
接受健康志愿者

入选标准

  • retransplanted at Children's Healthcare of Atlanta for late graft failure

排除标准

  • 未提供

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

William T. Mahle, MD

Principal Investigator

Emory University

研究点 (1)

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