Development of a Novel Convolution Neural Network for Arrhythmia Classification

NCT ID: NCT03662802

Last Updated: 2020-11-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

25458 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-10-01

Study Completion Date

2020-10-01

Brief Summary

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Identifying the correct arrhythmia at the time of a clinic event including cardiac arrest is of high priority to patients, healthcare organizations, and to public health. Recent developments in artificial intelligence and machine learning are providing new opportunities to rapidly and accurately diagnose cardiac arrhythmias and for how new mobile health and cardiac telemetry devices are used in patient care. The current investigation aims to validate a new artificial intelligence statistical approach called 'convolution neural network classifier' and its performance to different arrhythmias diagnosed on 12-lead ECGs and single-lead Holter/event monitoring. These arrhythmias include; atrial fibrillation, supraventricular tachycardia, AV-block, asystole, ventricular tachycardia and ventricular fibrillation, and will be benchmarked to the American Heart Association performance criteria (95% one-sided confidence interval of 67-92% based on arrhythmia type). In order to do so, the study approach is to create a large ECG database of de-identified raw ECG data, and to train the neural network on the ECG data in order to improve the diagnostic accuracy.

Detailed Description

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Conditions

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Arrhythmias, Cardiac Cardiac Arrest Cardiac Arrythmias

Keywords

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artificial intelligence machine learning neural network cardiac arrhythmia ECG EKG

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

Study Groups

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ECG Data

Coded data including; wavelengths, amplitude, intervals, timing, frequence

Neural Network Classifier

Intervention Type OTHER

The convolutional neural network is configured to receive an electrocardiogram segment as an input and to generate an output indicative of whether the received electrocardiogram segment represents a cardiac arrhythmia. No specific features of the electrocardiogram are identified to the convolutional neural network, and the received electrocardiogram segment is not filtered, transformed, or processed prior to reception by the algorithm. The algorithm is trained in a similar manner - the electrocardiogram segments are the sole input to the convolutional neural network.

Interventions

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Neural Network Classifier

The convolutional neural network is configured to receive an electrocardiogram segment as an input and to generate an output indicative of whether the received electrocardiogram segment represents a cardiac arrhythmia. No specific features of the electrocardiogram are identified to the convolutional neural network, and the received electrocardiogram segment is not filtered, transformed, or processed prior to reception by the algorithm. The algorithm is trained in a similar manner - the electrocardiogram segments are the sole input to the convolutional neural network.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* All ECG data compiled from 12-lead ECG, single, and multiple lead databases

Exclusion Criteria

* None
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Scripps Clinic

OTHER

Sponsor Role lead

Responsible Party

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Sanjeev Bhavnani MD

Principal Investigator - Healthcare Innovation

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Sanjeev Bhavnani, MD

Role: PRINCIPAL_INVESTIGATOR

Scripps Clinic Medical Group

Locations

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Scripps Clinic

San Diego, California, United States

Site Status

Countries

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United States

References

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Reference Type BACKGROUND
PMID: 29880128 (View on PubMed)

Kiranyaz S, Ince T, Gabbouj M. Real-Time Patient-Specific ECG Classification by 1-D Convolutional Neural Networks. IEEE Trans Biomed Eng. 2016 Mar;63(3):664-75. doi: 10.1109/TBME.2015.2468589. Epub 2015 Aug 14.

Reference Type BACKGROUND
PMID: 26285054 (View on PubMed)

Bhavnani SP, Parakh K, Atreja A, Druz R, Graham GN, Hayek SS, Krumholz HM, Maddox TM, Majmudar MD, Rumsfeld JS, Shah BR. 2017 Roadmap for Innovation-ACC Health Policy Statement on Healthcare Transformation in the Era of Digital Health, Big Data, and Precision Health: A Report of the American College of Cardiology Task Force on Health Policy Statements and Systems of Care. J Am Coll Cardiol. 2017 Nov 28;70(21):2696-2718. doi: 10.1016/j.jacc.2017.10.018. No abstract available.

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Reference Type RESULT
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Reference Type RESULT
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Arvanaghi R, Daneshvar S, Seyedarabi H, Goshvarpour A. Fusion of ECG and ABP signals based on wavelet transform for cardiac arrhythmias classification. Comput Methods Programs Biomed. 2017 Nov;151:71-78. doi: 10.1016/j.cmpb.2017.08.013. Epub 2017 Aug 24.

Reference Type RESULT
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Figuera C, Irusta U, Morgado E, Aramendi E, Ayala U, Wik L, Kramer-Johansen J, Eftestol T, Alonso-Atienza F. Machine Learning Techniques for the Detection of Shockable Rhythms in Automated External Defibrillators. PLoS One. 2016 Jul 21;11(7):e0159654. doi: 10.1371/journal.pone.0159654. eCollection 2016.

Reference Type RESULT
PMID: 27441719 (View on PubMed)

Li Q, Rajagopalan C, Clifford GD. Ventricular fibrillation and tachycardia classification using a machine learning approach. IEEE Trans Biomed Eng. 2014 Jun;61(6):1607-13. doi: 10.1109/TBME.2013.2275000. Epub 2013 Jul 26.

Reference Type RESULT
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Lyon A, Minchole A, Martinez JP, Laguna P, Rodriguez B. Computational techniques for ECG analysis and interpretation in light of their contribution to medical advances. J R Soc Interface. 2018 Jan;15(138):20170821. doi: 10.1098/rsif.2017.0821.

Reference Type RESULT
PMID: 29321268 (View on PubMed)

Mjahad A, Rosado-Munoz A, Bataller-Mompean M, Frances-Villora JV, Guerrero-Martinez JF. Ventricular Fibrillation and Tachycardia detection from surface ECG using time-frequency representation images as input dataset for machine learning. Comput Methods Programs Biomed. 2017 Apr;141:119-127. doi: 10.1016/j.cmpb.2017.02.010. Epub 2017 Feb 10.

Reference Type RESULT
PMID: 28241963 (View on PubMed)

Xiong Z, Nash MP, Cheng E, Fedorov VV, Stiles MK, Zhao J. ECG signal classification for the detection of cardiac arrhythmias using a convolutional recurrent neural network. Physiol Meas. 2018 Sep 24;39(9):094006. doi: 10.1088/1361-6579/aad9ed.

Reference Type RESULT
PMID: 30102248 (View on PubMed)

Fan X, Yao Q, Cai Y, Miao F, Sun F, Li Y. Multiscaled Fusion of Deep Convolutional Neural Networks for Screening Atrial Fibrillation From Single Lead Short ECG Recordings. IEEE J Biomed Health Inform. 2018 Nov;22(6):1744-1753. doi: 10.1109/JBHI.2018.2858789. Epub 2018 Aug 7.

Reference Type RESULT
PMID: 30106699 (View on PubMed)

Warrick PA, Nabhan Homsi M. Ensembling convolutional and long short-term memory networks for electrocardiogram arrhythmia detection. Physiol Meas. 2018 Oct 30;39(11):114002. doi: 10.1088/1361-6579/aad386.

Reference Type RESULT
PMID: 30010088 (View on PubMed)

Shen CP, Freed BC, Walter DP, Perry JC, Barakat AF, Elashery ARA, Shah KS, Kutty S, McGillion M, Ng FS, Khedraki R, Nayak KR, Rogers JD, Bhavnani SP. Convolution Neural Network Algorithm for Shockable Arrhythmia Classification Within a Digitally Connected Automated External Defibrillator. J Am Heart Assoc. 2023 Apr 18;12(8):e026974. doi: 10.1161/JAHA.122.026974. Epub 2023 Mar 21.

Reference Type DERIVED
PMID: 36942628 (View on PubMed)

Other Identifiers

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027527

Identifier Type: -

Identifier Source: org_study_id