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Published on: December 11, 2019
Electrocardiographic reference ranges derived from 79,743 ambulatory subjects
Jay W Mason1, Douglas J Ramseth, Dennis O Chanter
1Covance Cardiac Safety Services, Inc, Reno, NV 89521, USA. jay.mason@covance.com
Current electrocardiogram (ECG) reference ranges are outdated and do not reflect true age- and sex-related values. This study establishes new, modernized ECG reference ranges based on a large population using digital technology.
Area of Science:
- Cardiology
- Medical Diagnostics
- Biostatistics
Background:
- Existing electrocardiogram (ECG) reference ranges are not representative of large populations and lack modern technological basis.
- Current norms for ECG intervals, heart rate, and QRS axis may not accurately reflect diverse age and sex demographics.
Purpose of the Study:
- To establish updated, age- and sex-specific reference ranges for ECG parameters using modern digital interpretation methods.
- To compare new reference ranges with existing norms and assess the impact of age and sex on ECG values.
Main Methods:
- Analysis of 79,743 baseline ECGs from clinical trials, interpreted digitally by cardiologists.
- Identification of a subgroup (n=46,129) with low cardiovascular disease probability for reference range determination.
- Calculation of reference ranges using 2nd and 98th percentiles for heart rate, PR, QRS, QRS axis, QT, and QTc intervals.
Main Results:
- Significant age- and sex-related variations were observed in all measured ECG parameters.
- New reference ranges were established: heart rate (48-98 bpm), PR interval (113-212 ms), QRS interval (69-109 ms), QRS axis (-40° to 91°), QT interval (325-452 ms), QTc-Bazett (361-457 ms), QTc-Fridericia (359-445 ms).
- Digital interpretation showed minimal differences compared to paper tracings and computer algorithms.
Conclusions:
- Modernized ECG reference ranges are significantly different from previously reported norms and general use values.
- Age and sex profoundly influence normal ECG values, necessitating updated reference standards.
- Large cohort studies are crucial for comprehensive assessment, and ECG reference ranges require modernization.
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