Cardiac Safety Consultants Ltd, London, UK.
Richmond Research Institute, St George's University of London, London, UK.
Ann Noninvasive Electrocardiol. 2021 Sep;26(5):e12851. doi: 10.1111/anec.12851. Epub 2021 May 4.
In clinical trials, traditionally only a limited number of 12-lead resting electrocardiograms (ECGs) can be recorded and, thus, long intervals may elapse between assessment timepoints and valuable information may be missed during times when patients' cardiac electrical activity is not being monitored. These limitations have led to the increasing use of Holter recorders which provide continuous data registrations while reducing the burden on patients and freeing up time for clinical trial staff to perform other tasks. However, there is a shortage of data comparing the two approaches. In this study, data from a randomized, double-blind, four-period, crossover thorough QT study in 40 healthy subjects were used to compare continuous 12-lead Holter recordings to standard 12-lead resting ECGs which were recorded in parallel. Heart rate and QT interval data were estimated by averaging three consecutive heartbeats. Values exceeding the sample average by more than 5% were tagged as outliers and excluded from the analysis. Visual comparisons of the ECG waveforms of the Holter signal showed a good correlation with resting ECGs at matching timepoints. Resting ECG data revealed sex differences that Holter data did not show. Specifically, women were found to have a longer QTcF of 20 ms, while men had a lower heart rate. We found that continuous recordings provided a more accurate reflection of changes in cardiac electrical activity over 24 hr. However, manual adjudication is still required to ensure the quality and accuracy of ECG data, and that only artifacts are removed thereby avoiding loss of true signals.
在临床试验中，传统上只能记录有限数量的 12 导联静息心电图（ECG），因此，评估时间点之间可能会间隔很长时间，并且在患者心脏电活动未被监测的时间段内可能会错过有价值的信息。这些限制导致越来越多地使用 Holter 记录器，它提供连续的数据记录，同时减轻患者的负担，并为临床试验人员腾出时间执行其他任务。然而，目前缺乏比较这两种方法的数据。在这项研究中，使用了一项随机、双盲、四期、交叉全面 QT 研究中的 40 名健康受试者的数据，比较了连续 12 导联 Holter 记录与平行记录的标准 12 导联静息 ECG。通过平均三个连续心跳来估计心率和 QT 间期数据。超过样本平均值 5%的数值被标记为异常值并从分析中排除。Holter 信号的心电图波形的视觉比较显示与匹配时间点的静息 ECG 具有良好的相关性。静息 ECG 数据显示出 Holter 数据未显示的性别差异。具体来说，女性的 QTcF 延长 20ms，而男性的心率较低。我们发现，连续记录更准确地反映了 24 小时内心脏电活动的变化。然而，仍然需要手动判断来确保 ECG 数据的质量和准确性，并仅去除伪影，从而避免真实信号的丢失。
