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Non-invasive Prediction of EArly Cardiac rEjection (PEACE)

2026年8月17日 更新者：Jonathan Soslow、Vanderbilt University Medical Center

Predictive Modeling of Acute Rejection in Pediatric Heart Transplant Recipients

Acute rejection remains a major cause of morbidity and mortality in pediatric patients after heart transplant. In order to screen for rejection, most centers perform heart catheterizations with endomyocardial biopsies frequently in the first year post transplant and then every 1-2 years thereafter; these biopsies are associated with complications, can cause significant anxiety in patients and family members, and are a significant cost for the healthcare system. This project will evaluate non-invasive methods of detecting rejection using cardiac magnetic resonance imaging and blood testing with a goal to reduce the required number of cardiac catheterizations.

研究概览

地位

招聘中

条件

详细说明

Despite significant advances in the care of pediatric heart transplant (PHTx) patients, acute rejection (AR) remains one of the leading causes of death. Cardiac catheterization with endomyocardial biopsy (biopsy) is the standard of care for diagnosing AR and is performed when there is a clinical suspicion for AR or during routine surveillance. Unfortunately, biopsy is invasive and associated with potential risks, including: complications from anesthesia or sedation, valve damage, injury to the conduction system, vascular damage or occlusion, and cardiac perforation. These potential complications are magnified in the pediatric population. Non-invasive methods of detecting AR, such as blood biomarkers and cardiac magnetic resonance imaging (CMR), could decrease the frequency of biopsy. Blood biomarkers, such has donor fraction cell-free DNA and microRNA, have shown potential for diagnosis of AR but have not yet gained widespread adoption in PHTx. Advanced CMR parametric mapping sequences quantify myocardial fibrosis and edema, and our preliminary data suggest a potential for these sequences to diagnose AR. While CMR parametric mapping has significant promise, focusing simply on the average properties across an entire left ventricular plane or region ignores the spatial patterns of disease, resulting in a loss of information and an impaired ability to use the imaging data to direct care. Here we propose advanced image analysis methods that are more granular than plane analysis, including texture analysis, as a means for objectively analyzing different patterns of myocardial disease and developing predictive models that would allow improved clinical decision making. The central hypothesis of this grant is that non-invasive cardiac magnetic resonance and blood biomarkers can detect myocardial abnormalities consistent with acute rejection in pediatric heart transplant recipients and can predict the need for endomyocardial biopsy. To address this hypothesis, Aim 1 will develop and validate a comprehensive predictive model for identifying PHTx recipients having suspected AR and requiring cardiac catheterization. Aim 2 will evaluate whether blood biomarkers improve the CMR model developed in Aim 1. SubAims will include assessment of cost to determine the most cost-efficient screening protocol. Aim 3 will expand modeling to determine severity of AR as defined histologically. This multi-PI proposal is a prospective, multicenter study to perform CMR in PHTx with and without AR who are also undergoing clinical biopsy. The innovation of this study is the use of advanced CMR, texture analysis, and blood biomarkers for the non-invasive detection of AR. This proposal leverages the support of the Congenital/Pediatric Research Committee within the Society of Cardiovascular Magnetic Resonance (SCMR). Application of these data to clinical practice could improve quality of life and decrease associated morbidity by ensuring that only patients with a high probability of rejection undergo biopsy.

研究类型

观察性的

注册 (估计的)

200

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

  • 姓名：Jonathan Soslow, MD MSCI
  • 电话号码：615-322-7447
  • 邮箱：PEACE@vumc.org

学习地点

  • 美国
    • Arkansas
      • Little Rock、Arkansas、美国、72202
        • 招聘中
        • Arkansas Children's Hospital
        • 接触：
          • Study Coordinator
          • 电话号码：501-364-4000
          • 邮箱：peac@vumc.org
    • California
      • Los Angeles、California、美国、90027
        • 招聘中
        • Children's Hospital of Los Angeles
        • 接触：
          • Study Coordinator
          • 电话号码：323-361-2461
      • Los Angeles、California、美国、90095
        • 招聘中
        • UCLA
        • 接触：
          • Study Coordinator
          • 电话号码：310-267-7667
          • 邮箱：peace@vumc.org
      • Palo Alto、California、美国、94304
        • 招聘中
        • Lucile Packard Children's Hospital at Stanford
        • 接触：
          • Study Coordinator
          • 电话号码：650-337-3766
          • 邮箱：peace@vumc.org
      • San Diego、California、美国、92123
        • 招聘中
        • Rady Children's Hospital
        • 接触：
          • Study Coordinator
          • 电话号码：858-966-5855
          • 邮箱：peace@vumc.org
    • Colorado
      • Denver、Colorado、美国、13123
        • 招聘中
        • Children's Hospital Colorado
        • 接触：
          • Study Coordinator
          • 电话号码：720-777-6820
          • 邮箱：peace@vumc.org
    • Florida
      • Gainesville、Florida、美国、32608
        • 招聘中
        • University of Florida
        • 接触：
          • Study Coordinator
          • 电话号码：(352) 273-7770
          • 邮箱：peace@vumc.org
      • Hollywood、Florida、美国、33021
        • 招聘中
        • Joe DiMaggio Children's Hospital
        • 接触：
          • Study Coordinator
          • 电话号码：954-265-3437
          • 邮箱：peace@vumc.org
    • Georgia
      • Atlanta、Georgia、美国、30322
        • 招聘中
        • Children's Hospital of Atlanta
        • 接触：
          • Study Coordinator
          • 电话号码：404-256-2593
          • 邮箱：peace@vumc.org
    • Illinois
      • Chicago、Illinois、美国、02115
        • 招聘中
        • Lurie Children's Hospital
        • 接触：
          • Study Coordinator
          • 电话号码：312-227-4000
          • 邮箱：peace@vumc.org
    • Indiana
      • Indianapolis、Indiana、美国、46202
        • 招聘中
        • Riley Children's Hospital
        • 接触：
          • Study Coordinator
          • 电话号码：317-944-8906
          • 邮箱：peace@vumc.org
    • Massachusetts
      • Boston、Massachusetts、美国、02115
        • 招聘中
        • Boston Children's Hospital
        • 接触：
          • Study Coordinator
          • 电话号码：617-355-6000
          • 邮箱：peace@vumc.org
    • Michigan
      • Ann Arbor、Michigan、美国、48109
        • 招聘中
        • University of Michigan
        • 接触：
          • Study Coordinator
          • 电话号码：734-764-5176
          • 邮箱：peace@vumc.org
    • Missouri
      • St Louis、Missouri、美国、63110
        • 招聘中
        • Washington University
        • 接触：
          • Study Coordinator
          • 电话号码：314-454-6095
          • 邮箱：peace@vumc.org
    • New York
      • New York、New York、美国、10032
        • 招聘中
        • Columbia University
        • 接触：
          • Study Coordinator
          • 电话号码：212-305-4432
          • 邮箱：peace@vumc.org
      • New York、New York、美国、10029
        • 招聘中
        • Mount Sinai Kravis Children's Hospital
        • 接触：
          • Study Coordinator
          • 电话号码：212-241-9500
          • 邮箱：peace@vumc.org
    • Ohio
      • Columbus、Ohio、美国、43205
        • 招聘中
        • Nationwide Children's Hospital
        • 接触：
          • Study Coordinator
          • 电话号码：614-722-2530
          • 邮箱：peace@vumc.org
    • Tennessee
      • Nashville、Tennessee、美国、37232
        • 招聘中
        • Vanderbilt University Medical Center
        • 接触：
    • Texas
      • Houston、Texas、美国、77030
        • 招聘中
        • Texas Children's Hospital
        • 接触：
          • Study Coordinator
          • 电话号码：832-824-3278
          • 邮箱：peace@vumc.org
      • Houston、Texas、美国、77030
        • 招聘中
        • UT Health Houston
        • 接触：
          • Study Coordinator
          • 电话号码：713-486-6755
          • 邮箱：peace@vumc.org
    • Washington
      • Seattle、Washington、美国、98105
        • 招聘中
        • Seattle Children's Hospital
        • 接触：
          • Study Coordinator
          • 电话号码：206-987-2000
          • 邮箱：peace@vumc.org
    • Wisconsin
      • Milwaukee、Wisconsin、美国、53226
        • 招聘中
        • Medical College of Wisconsin
        • 接触：
          • Study Coordinator
          • 电话号码：414-266-6457
          • 邮箱：peace@vumc.org

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 孩子
  • 成人

接受健康志愿者

不

取样方法

非概率样本

研究人群

Pediatric heart transplant recipients undergoing endomyocardial biopsy either for concerns of rejection or for routine surveillance.

描述

Inclusion Criteria:

  • Received heart transplant at age < 21 years old
  • > 2 months from transplant
  • ≥6 years old and ≤ 25 years old and able to undergo cardiac MRI (CMR)
  • CMR can be scheduled within 5 days from heart biopsy*
  • Heart catheterization with biopsy is scheduled "for cause" to confirm suspected AR or Heart catheterization with biopsy is scheduled for surveillance

Exclusion Criteria:

  • No endomyocardial biopsy scheduled
  • Other illness or disease process that could potentially lead to myocardial edema or fibrosis
  • Contraindication to CMR with contrast
  • Previously enrolled in this study, UNLESS previous enrollment was heart biopsy scheduled for surveillance with no suspicion of AR AND final study status was documented as "no AR" AND current enrollment is heart biopsy is scheduled "for cause" to confirm suspected AR
  • Multiple transplanted organs
  • Requires anesthesia for CMR

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

队列和干预

团体/队列
Healthy pediatric heart transplant recipients
Pediatric heart transplant recipients not having rejection
Pediatric heart transplant recipients with acute rejection
Pediatric heart transplant recipients with acute rejection (ACR or AMR) as defined by the the core pathologist.
Healthy controls
Healthy control patients retrospectively enrolled at each site to standardize parametric mapping.

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
Acute rejection
大体时间：time of enrollment
Rejection is defined as a clinical event that results in augmentation of immunosuppression. Core pathology laboratory will determine biopsy positive vs biopsy negative rejection.
time of enrollment

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Vanderbilt University Medical Center

合作者

National Heart, Lung, and Blood Institute (NHLBI)

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2023年3月29日

初级完成 (估计的)

2027年2月1日

研究完成 (估计的)

2027年6月30日

研究注册日期

首次提交

2026年8月12日

首先提交符合 QC 标准的

2026年8月12日

首次发布 (实际的)

2026年8月18日

研究记录更新

最后更新发布 (实际的)

2026年8月20日

上次提交的符合 QC 标准的更新

2026年8月17日

最后验证

2026年6月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • 220773
  • R01HL164995 (美国 NIH 拨款/合同)

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

是的

IPD 共享时间框架

Study conclusion

IPD 共享访问标准

We will honor requests for sharing of requested data for non-profit research purposes.

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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