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临床试验/NCT00366886
NCT00366886终止不适用

Retrospective Review of 22 Patients With NMDA Biomarker Data Following Cardiac Surgery

Children's Healthcare of Atlanta1 个研究点 分布在 1 个国家目标入组 22 人开始时间: 2006年8月21日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
22
试验地点
1

研究概览

简要总结

The purpose of this current retrospective study is to perform follow-up analysis on the 22 children from the study # 621-2004 It is important to examine whether an elevated biomarker of brain ischemia before and/or following cardiac surgery has any clinical or functional implications as the child ages.

详细描述

The N-Methyl-D-Aspartate (NMDA) receptor is unique to the brain. With brain injury or ischemia, fragments of the NMDA receptor (NR2) break off and appear in the bloodstream. These NR2 fragments generate an antibody response (NR2 ab) from the body. A recently developed blood test (CIS-Biotech, Inc) is able to measure these fragments (NR2) and the antibody (NR2 ab) response. In adult patients who suffer from ischemic stroke, elevated blood levels of NR2 ab correlate with the amount of brain damage on brain magnetic resonance imaging.

The purpose of the past prospective study, "Blood Markers of Brain Injury from Cardiopulmonary Bypass and Deep Hypothermic Circulatory Arrest in Infants and Children", Emory #621-2004, was to observe the expression of blood markers of brain ischemia, NMDA receptor fragment (NR2) and antibody (NR2 ab) in infants with congenital heart disease before and after cardiac surgery.

Our intent is to review hospital medical records, the cardiothoracic surgical database and neurological database at Children's Healthcare of Atlanta to assess their clinical and functional outcomes. We will review surgery information, clinic visits to Sibley Heart Center Cardiology, and echo, MRI and neurological testing results as well as mortality for these patients. No patient will be contacted. This retrospective study is important as a follow-up to the initial prospective pilot study as it will provide information regarding the clinical outcome of the patients.

研究设计

研究类型
Observational
观察模型
Defined Population
时间视角
Retrospective

入排标准

年龄范围
— 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • participated in previous 621-2004 blood marker study for infants and children having open-heart surgery with cardiopulmonary bypass with or without hypothermic circulatory arrest

排除标准

  • Those who do not meet inclusion criteria

研究者

申办方类型
Other

研究点 (1)

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