Comparing the consistency of electrocardiogram interval measurements by resting ECG versus 12-lead Holter
Boaz Mendzelevski1, Christopher S Spencer2, Anne Freier2
1Cardiac Safety Consultants Ltd, London, UK.
Insights
Continuous Holter monitoring offers a more accurate cardiac electrical activity assessment than standard ECGs in clinical trials. Manual review remains crucial for data quality and artifact removal.
Area of Science:
- Cardiology
- Clinical Pharmacology
- Biomedical Engineering
Background:
- Traditional 12-lead resting electrocardiograms (ECGs) in clinical trials have limitations due to infrequent recordings, potentially missing critical cardiac events.
- Holter recorders offer continuous ECG monitoring, reducing patient burden and optimizing clinical trial staff resources.
- Comparative data between Holter monitoring and standard resting ECGs in clinical trials is limited.
Purpose of the Study:
- To compare the efficacy of continuous 12-lead Holter recordings versus standard 12-lead resting ECGs in capturing cardiac electrical activity.
- To evaluate the accuracy and data quality of Holter monitoring in a thorough QT study setting.
- To identify potential differences in detecting sex-specific cardiac parameters between the two methods.
Main Methods:
- A randomized, double-blind, four-period, crossover thorough QT study was conducted in 40 healthy subjects.
- Continuous 12-lead Holter recordings were compared against parallel standard 12-lead resting ECGs.
- Heart rate and QT interval data were averaged from three consecutive heartbeats, with outliers (>5% deviation) excluded.
Main Results:
- Visual comparison showed good correlation between Holter ECG waveforms and resting ECGs at corresponding timepoints.
- Continuous Holter recordings provided a more accurate reflection of cardiac electrical activity changes over 24 hours.
- Resting ECGs revealed sex differences (e.g., longer QTcF in women, lower heart rate in men) not evident in Holter data analysis without specific adjudication.
Conclusions:
- Continuous Holter monitoring is superior for reflecting dynamic changes in cardiac electrical activity over extended periods.
- While Holter monitoring offers advantages, manual adjudication is essential for ensuring ECG data quality and differentiating true signals from artifacts.
- Further research may be needed to optimize Holter data analysis for detecting subtle sex-specific differences in cardiac parameters.
Abstract:
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.
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