Clinical trial NCT03753139: Identification of Arrhythmias With One-time ECG
Official title: Identification of Arrhythmias With One-time ECG
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Atrial Fibrillation
Heart Rate Fast
Heart Rate Low
Keywords: Atrial fibrillation; detection; portable device; algorithms
Lead sponsor: Kuopio University Hospital
Sponsor class: OTHER
Collaborators: name: University of Eastern Finland
First posted: 2018-11-26
Enrollment: 260
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: A total of 300 patients will be recruited in the research: 100 patients with normal sinus rhythm, 100 with atrial fibrillation, 50 with rapid rhythm (tachycardia, resting heart rate \> 100 bpm) and 50 slow rhythms (bradycardia, resting heart rate\< 50bpm).

Brief summary: In Western countries, every sixth person in their lifetime and 15,000 people in Finland have a new stroke each year. About every fourth stroke is based on cardiac embolism. Atrial fibrillation causes formation of thrombi in the left atrium with ensuing embolization in the cerebral and peripheral circulation.

This study investigates the suitability of measurement techniques and new calculation methods used in sport/wellness technology for the screening and diagnosis of atrial fibrillation and other arrhythmias. New measurement technologies, the one-time ECG measurement and pulse wristband measurement, are studied for their characteristics, data quality and rhythm recognition. Identifying latent arrhythmias with new self-monitoring technologies can significantly reduce the number of strokes (the latent arrhythmias causes about 25% of strokes).

The research will be accomplished in cooperation with the Kuopio University Hospital Emergency Department, the Heart Center, the Department of Applied Physics of the University of Eastern Finland and Heart2Save Ltd.

The results of the research project will be published in the scientific journals of medicine and medical technology and will be presented at scientific conferences of the respective fields. The research results of the project can be utilized by all companies in the medical technology industry, in particular companies that produce ECG measuring instruments and companies that produce rhythm recognition software.

Detailed description: The research aims to solve the following medical problems:

1. Identifying and defining the type of atrial fibrillation is problematic due to its spontaneous occurrence and latency.
2. Measurement devices for screening atrial fibrillation are poorly available.

The main research questions are:

1. Can a single-lead ECG measurement be used to detect arrhythmias

   1. Find out the measurement locations (ECG leads) for single-lead ECG self-monitoring and evaluate the impact of measurement locations on usability and signal quality.
   2. Find out the measurement locations for single-lead ECG monitoring when the measurement is performed by another person (nurse or relative) and evaluate the impact of measurement locations on usability and signal quality.
   3. Find out the reliability of single-lead ECG measurement for the identification of atrial fibrillation.
   4. Find out the reliability of single-lead ECG measurement for identification of rapid (tachycardia) and slow heart rate (bradycardia).
2. Can a wristband based on optical pulse registration be able to obtain reliable information about arrhythmias

   1. Find out the usability of the pulse wristband for the identification of atrial fibrillation.
   2. Find out the usability of the pulse wristband for the identification of rapid (tachycardia) and slow heart rate (bradycardia).

The purpose of the study's method development is to evaluate reliability of heart rate measurement in single-lead ECG and pulse wave measurement with healthy and patients with heart problems. The study develops computing methods based on lightweight measurement technology to reliably identify the most common cardiac arrhythmia, atrial fibrillation. The diagnosis and treatment of atrial fibrillation are decisive factors for preventing strokes.

Research patients have already undergone a 12-channel clinical ECG registration included in the normal treatment process. This 12-channel ECG is used for the identification of patients suitable for research and dividing to subgroups (normal rhythm, atrial fibrillation, rapid or slow rhythm).

In actual study measurements, a Holter-ECG device is attached on patient's chest using five wet electrodes to be used as golden standard for rhythm monitoring. The lightweight measurement methods are compared with the result of the Holter-ECG registration. In addition, photopletysmogram is placed on patient's wrist for PPG registration. Figure 1 shows illustrative examples of the study's measurements.

The researcher measures one minute recordings from two different measuring positions (flank and chest) with a one-time ECG measuring device. After that, the patient performs one minute self-monitoring measurements with one-time ECG device from the all three positions (thumbs, flank and chest) and also from the chest with jewel-ECG.

The study compares the ability of these lightweight measurement methods to detect different heart rhythms compared to the Holter registration.

The devices used for the measurement are:

1. Faros 360 EKG sensor with wet electrodes (figure 1, device 1) (Mega Elektroniikka, http://www.megaemg.com/ Kuopio Suomi). Faros 360 Holter is CE and FDA 510(k) cleared class 2a medical device, which is attached to the patient's chest with five single-use wet electrodes.
2. Suunto Movesense one-time ECG device (Suunto Oy, http://www.suunto.com Vantaa Suomi). Movesense is CE cleared consumer device, which is used with two dy electrodes to the ECG measurement (Figure 1 devices 2 and 3). Movesense case; jewel and one-time ECG case.

   1. In the previous study (Afib24h), Valvira was reported and the research received permission for the clinical device study (Movesense + chest strap combination).
   2. For this study, Valira is reported for a clinical device study (Movesense + one-time ECG device combination)
3. Empatica E4 activity bracelet (Empatica Ltd http://www.empatica.com Milan Italia), which is CE cleared consumer device. Empatica E4 is also a photopletysmogram, which measures optically the amount of blood circulating in the blood vessel (Figure 1 device 4).
4. Samsung Gear S3 wearable (Samsung Electronics, Co., Ltd., www.samsung.com Soul Etelä-Korea) which is CE cleared consumer device. Gear S3 is also a photopletysmogram, which measures optically the amount of blood circulating in the blood vessel.

The researcher attaches devices to the patient. After that, the researcher starts a 10-minute registration with Faros 360 (device 1) and Empatica E4 (device 4) devices. During a 10-minute measurement, the researcher measures one minute recordings from two different measuring positions with the Movesense ECG (device 2) 1. from the chest, sternum perpendicularly 2. from the chest, along the sternum. The patient then carries out one minute self-monitoring measurements 1. from the chest, sternum perpendicularly 2. from the chest, along the sternum 3. from the lower part of the flank 4. from thumbs and 5. from the chest with a jewel-ECG.

Heart rate detection by ECG measurement is most commonly done by the detection of QRS complexes. Numerous of these QRS detectors have been developed in recent decades. ECG measurement with dry electrodes involves considerably more movement disturbances, compared to the wet electrode measurements, as even the small movements of the device induce major changes to the ECG signal. In addition, especially when using thumbs as a measurement points, the EMG noise from the muscles is remarkably high compared to the wet electrode measurements.

This project utilizes the methods developed in the earlier mobile-ECG-project for noise and QRS detection to allow reliably detection of QRS complexes and heart rate irregularities in the dry electrode measurements.

In this study, the previously developed heart rate detection methods are validated by study's measurements of normal sinus rhythm, atrial fibrillation, and slow (bradycardia) and rapid (tachycardia) heart rate.

This study examines capability of pulse detection in detection of atrial fibrillation. The photopletysmogram measures the absorption of light in the tissue. The absorption of light into the blood is greater than the absorption into the surrounding tissue. When the heart beats, capillaries expand and contract based on blood volume changes. Photopletysmography allows the heart rate measurement by detecting changes in absorption.

Photopletysmgram, like a mobile-ECG device, is particularly sensitive to motion, even the small motion of led/photodiode induce major change in light intensity.

Also, physiological changes cause a disturbance in heart rate measurement, for example, as the vascular elasticity changes, the pulse time changes, resulting a disturbance in measurement.

Unlike the high-frequency pierced QRS complex, the pulse wave is a low-frequency up-down variation, which causes its own challenges for accurate heart rate measurement.

The atriums work insufficiently in atrial fibrillation therefore the ventricles are not completely filled with blood. In addition, atrial fibrillation causes the irregular conduction of impulses from atriums to the ventricles leading to pulse irregularity. The amount of blood pumped varies from one stroke to stroke, which makes the pulse wave detection challenging.

This project develops methods for accurate heart rate measurement from a pulse wave series.

The method development aims to take account of disturbances due to the motion of the meter, pulse wave irregularities typical of atrial fibrillation, and the challenges of slow (bradycardia) and rapid (tachycardia) heart rate detection.

The main goal of the method development is to determine the pulse so precisely that pulse irregularity due to atrial fibrillation can be distinguished from normal sinus rhythm and reliably detect rapid and slow heart rhythms.

In atrial fibrillation, electrical impulses conduct randomly to the ventricles, causing the heart rate to be irregular and uneven. A large campaign by the Heart Association "Feel your pulse - prevent the stroke" is based on heart rate or pulse recognition. Pulse recognition is of course the cheapest method to detect atrial fibrillation, but this method produces a large number of false positives. By ECG measurement, the detection of atrial fibrillation is much more reliable. Automated atrial fibrillation detection algorithms have been developed for this purpose.

Identification of the atrium activation in long-term Holter-ECG measurements is generally very challenging due to the poor signal-noise-ratio (motion, muscle-artefacts and partly overlapping much stronger ventricular activity). For this reason, most atrial fibrillation detection algorithms are based on the identification of pulse irregularity. For parametrization of the irregularity of the heart rate (RR-interval) has been introduced several relatively simple but reliable time-level methods. As an example, A RdR-based method wherein the RR intervals (heart rate) are represented as a function of consecutive RR interval changes (heart rate change) (Lian et al. 2011). The RdR-graph defines the fragmentation of the pattern resulting from irregular heart rate changes. In addition, there are methods that estimate RR time series internal coherence (Lee et al. 2011). Various nonlinear methods have also been introduced to parametrization of the heart rate variation, enabling the dynamics of the heart rate variation to be described more broadly (without limitation of the linearity assumption). One class of nonlinear methods are different entropy quantities, these are particularly interesting for the identification of atrial fibrillation and the irregular heart rate. Entropy quantities can be used to estimate the regularity and predictability of the RR time series. Typically, the reliable calculation of the entropy quantities requires a relatively long measurement time, but also entropy quantities that are suitable for the analysis of short measurements have been introduced (Lake \& Moorman 2011).

This research project develops new atrial fibrillation detection algorithms for the mobile-ECG measurement and pulse wave measurement on the basis of already existing methods. Algorithms must take into account atrial and ventricular premature complexes. Ignoring of these increases the irregularity of the RR time series and thus increases the number of false positive atrial fibrillation.

Eligibility criteria: Inclusion Criteria:

* Patients treated for any reason in the emergency department of Kuopio University Hospital.

Exclusion Criteria:

* body mass index (BMI) over 35, implanted heart pacemaker device and a medical condition requiring immediate treatment that would be delayed by the study measurements.

Primary outcomes:
measure: Heart rhythm monitoring with single-lead ECG
timeFrame: 30 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Kuopio
country: Finland
facility: Kuopio university hospital
state: Eastern-Finland
Study officials:
affiliation: Kuopio University Hospital
name: Tero J Martikainen, MD. PhD
role: PRINCIPAL_INVESTIGATOR
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