Remote noninvasive allograft rejection monitoring for heart transplant recipients: study protocol for the novel evaluation with home electrocardiogram and remote transmission (NEW HEART) study.
Remote noninvasive allograft rejection monitoring for heart transplant recipients: study protocol for the novel evaluation with home electrocardiogram and remote transmission (NEW HEART) study.
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DOI：
10.1186/1471-2261-12-14
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发表时间：
2012-03-02
影响因子：
2.1
通讯作者：
Drew BJ
中科院分区：
文献类型：
--
作者：
Doering LV;Hickey K;Pickham D;Chen B;Drew BJ
急性同种异体移植排斥是成人心脏移植后第一年早期死亡的主要原因。尽管心内膜心肌活检（EMB）并不是正确诊断急性同种异体移植排斥反应的完美“金标准”，但它被认为是最好的可用测试，因此是当前的标准做法。不幸的是，EMB 是一种侵入性且昂贵的手术，并非没有风险。最近的证据表明，急性同种异体移植排斥会导致心室复极延迟，从而增加细胞动作电位持续时间，导致心电图 (ECG) 上的 QT 间期更长。迄今为止，还没有前瞻性研究调查 QT 间期的这种增加是否可以提供急性同种异体移植排斥的早期检测。因此，在家庭心电图和远程传输的新颖评估（NEW HEART）研究中，我们计划研究每日家庭 QT 间期监测对预测急性同种异体移植排斥的潜在益处。 NEW HEART 研究是一项前瞻性、双盲、多中心描述性研究。移植后六周内将从美国的三个地点招募 325 名成年心脏移植受者样本。受试者将收到 HeartView™ 心电图记录仪及其配套的互联网发射器，该发射器将受试者的心电图传输到核心实验室。将指示受试者在 6 个月内每天记录和传输心电图记录。 QTC 间隔较前一天增加至少 25 毫秒并连续 3 天将被视为异常。将在移植手术后一年内收集急性同种异体移植排斥反应的次数和级别以及全因死亡率。这项研究将提供“真实世界”的前瞻性数据，以确定 QTC 作为移植受者在移植后第一年细胞排斥的早期非侵入性标志物的敏感性和特异性。心脏移植受者早期同种异体移植排斥反应的非侵入性指标有可能通过减少排斥反应监测的时间和成本以及缩短识别排斥反应的时间来限制排斥反应的次数和严重程度。 ClinicalTrials.gov：NCT01365806
Acute allograft rejection is a major cause of early mortality in the first year after heart transplantation in adults. Although endomyocardial biopsy (EMB) is not a perfect "gold standard" for a correct diagnosis of acute allograft rejection, it is considered the best available test and thus, is the current standard practice. Unfortunately, EMB is an invasive and costly procedure that is not without risk. Recent evidence suggests that acute allograft rejection causes delays in ventricular repolarization and thereby increases the cellular action potential duration resulting in a longer QT interval on the electrocardiogram (ECG). No prospective study to date has investigated whether such increases in the QT interval could provide early detection of acute allograft rejection. Therefore, in the Novel Evaluation With Home Electrocardiogram And Remote Transmission (NEW HEART) study, we plan to investigate the potential benefit of daily home QT interval monitoring to predict acute allograft rejection. The NEW HEART study is a prospective, double-blind, multi-center descriptive research study. A sample of 325 adult heart transplant recipients will be recruited within six weeks of transplant from three sites in the United States. Subjects will receive the HeartView™ ECG recorder and its companion Internet Transmitter, which will transmit the subject's ECG to a Core Laboratory. Subjects will be instructed to record and transmit an ECG recording daily for 6 months. An increase in the QTC interval from the previous day of at least 25 ms that persists for 3 consecutive days will be considered abnormal. The number and grade of acute allograft rejection episodes, as well as all-cause mortality, will be collected for one year following transplant surgery. This study will provide "real world" prospective data to determine the sensitivity and specificity of QTC as an early non invasive marker of cellular rejection in transplant recipients during the first post-transplant year. A non-invasive indicator of early allograft rejection in heart transplant recipients has the potential to limit the number and severity of rejection episodes by reducing the time and cost of rejection surveillance and by shortening the time to recognition of rejection. ClinicalTrials.gov: NCT01365806
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影响因子：
0.9
作者：
Fiorelli, A. I.;Coelho, G. H. B.;Stolf, N. A. G.
通讯作者：
Stolf, N. A. G.
影响因子：
8.9
作者：
Vrtovec, B;Radovancevic, R;Radovancevic, B
通讯作者：
Radovancevic, B
影响因子：
8.9
作者：
Überfuhr, P;Frey, AW;Schwaiger, M
通讯作者：
Schwaiger, M
影响因子：
2.8
作者：
Jalowiec, Anne;Grady, Kathleen L.;White-Williams, Connie
通讯作者：
White-Williams, Connie
影响因子：
158.5
作者：
Pham, Michael X.;Teuteberg, Jeffrey J.;Valantine, Hannah A.
通讯作者：
Valantine, Hannah A.