Identification of Arrhythmias With One-time ECG

NCT03753139 | Completed

• 1 other identifier: KUH507P002
• Study Type: observational
• Target: 260
• Locations: 1 country
• Sites: 1

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.

Conditions

Atrial Fibrillation; Heart Rate Fast; Heart Rate Low

Keywords

Atrial fibrillation; detection; portable device; algorithms

Outcome Measures

Primary Outcomes (1)

• Heart rhythm monitoring with single-lead ECG

  Sensitivity and Specificity for the atrial fibrillation detection

  30 minutes

Study Arms (2)

Atrial fibrillation

Patients with atrial fibrillation as recorded by Holter

Device: Heart rhythm monitoring with portable device

Sinus rhythm

Patients with sinus rhythm as recorded by Holter

Device: Heart rhythm monitoring with portable device

Interventions

Heart rhythm monitoring with portable device DEVICE

The study compares the ability of lightweight measurement methods to detect different heart rhythms compared to the Holter registration. 1. Faros 360 ECG sensor with wet electrodes. Faros 360 Holter is CE and FDA 510 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 Finland). Movesense is CE cleared consumer device, which is used with two dry electrodes to the ECG measurement. 3. Empatica E4 activity bracelet (Empatica Ltd http://www.empatica.com Milan, Italy), which is CE cleared consumer device. Empatica E4 is a photopletysmogram which measures optically the amount of blood circulating in the blood vessel. 4. Samsung Gear S3 wearable (Samsung Electronics, Co., Soul, South Korea) which is CE cleared consumer device. Gear S3 is a photopletysmogram, which measures optically the amount of blood circulating in the blood vessel.

Atrial fibrillation; Sinus rhythm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Kuopio University Hospital: lead
• University of Eastern Finland: collaborator

Study Sites (1)

Kuopio university hospital

Kuopio, Eastern-Finland, 70029, Finland

Location

Related Publications (24)

• Amann A, Tratnig R, Unterkofler K. Reliability of old and new ventricular fibrillation detection algorithms for automated external defibrillators. Biomed Eng Online. 2005 Oct 27;4:60. doi: 10.1186/1475-925X-4-60.

  PMID: 16253134 BACKGROUND

• Barro S, Ruiz R, Cabello D, Mira J. Algorithmic sequential decision-making in the frequency domain for life threatening ventricular arrhythmias and imitative artefacts: a diagnostic system. J Biomed Eng. 1989 Jul;11(4):320-8. doi: 10.1016/0141-5425(89)90067-8.

  PMID: 2755113 BACKGROUND

• Cabello D, Barro S, Salceda JM, Ruiz R, Mira J. Fuzzy K-nearest neighbor classifiers for ventricular arrhythmia detection. Int J Biomed Comput. 1991 Feb;27(2):77-93. doi: 10.1016/0020-7101(91)90089-w.

  PMID: 2032755 BACKGROUND

• Chen SW. A two-stage discrimination of cardiac arrhythmias using a total least squares-based prony modeling algorithm. IEEE Trans Biomed Eng. 2000 Oct;47(10):1317-27. doi: 10.1109/10.871404.

  PMID: 11059166 BACKGROUND

• al-Fahoum AS, Howitt I. Combined wavelet transformation and radial basis neural networks for classifying life-threatening cardiac arrhythmias. Med Biol Eng Comput. 1999 Sep;37(5):566-73. doi: 10.1007/BF02513350.

  PMID: 10723893 BACKGROUND

• Fuster V, Ryden LE, Cannom DS, Crijns HJ, Curtis AB, Ellenbogen KA, Halperin JL, Le Heuzey JY, Kay GN, Lowe JE, Olsson SB, Prystowsky EN, Tamargo JL, Wann S; Task Force on Practice Guidelines, American College of Cardiology/American Heart Association; Committee for Practice Guidelines, European Society of Cardiology; European Heart Rhythm Association; Heart Rhythm Society. ACC/AHA/ESC 2006 guidelines for the management of patients with atrial fibrillation-executive summary: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines and the European Society of Cardiology Committee for Practice Guidelines (Writing Committee to Revise the 2001 Guidelines for the Management of Patients with Atrial Fibrillation). Eur Heart J. 2006 Aug;27(16):1979-2030. doi: 10.1093/eurheartj/ehl176. No abstract available.

  PMID: 16885201 BACKGROUND

• Ge D, Srinivasan N, Krishnan SM. Cardiac arrhythmia classification using autoregressive modeling. Biomed Eng Online. 2002 Nov 13;1:5. doi: 10.1186/1475-925x-1-5.

  PMID: 12473180 BACKGROUND

• Jekova I. Comparison of five algorithms for the detection of ventricular fibrillation from the surface ECG. Physiol Meas. 2000 Nov;21(4):429-39. doi: 10.1088/0967-3334/21/4/301.

  PMID: 11110242 BACKGROUND

• Lake DE, Moorman JR. Accurate estimation of entropy in very short physiological time series: the problem of atrial fibrillation detection in implanted ventricular devices. Am J Physiol Heart Circ Physiol. 2011 Jan;300(1):H319-25. doi: 10.1152/ajpheart.00561.2010. Epub 2010 Oct 29.

  PMID: 21037227 BACKGROUND

• Lee J, Nam Y, McManus DD, Chon KH. Time-varying coherence function for atrial fibrillation detection. IEEE Trans Biomed Eng. 2013 Oct;60(10):2783-93. doi: 10.1109/TBME.2013.2264721. Epub 2013 May 22.

  PMID: 23708769 BACKGROUND

• Li C, Zheng C, Tai C. Detection of ECG characteristic points using wavelet transforms. IEEE Trans Biomed Eng. 1995 Jan;42(1):21-8. doi: 10.1109/10.362922.

  PMID: 7851927 BACKGROUND

• Lian J, Wang L, Muessig D. A simple method to detect atrial fibrillation using RR intervals. Am J Cardiol. 2011 May 15;107(10):1494-7. doi: 10.1016/j.amjcard.2011.01.028. Epub 2011 Mar 17.

  PMID: 21420064 BACKGROUND

• Lipponen JA, Tarvainen MP, Laitinen T, Lyyra-Laitinen T, Karjalainen PA. A principal component regression approach for estimation of ventricular repolarization characteristics. IEEE Trans Biomed Eng. 2010 May;57(5):1062-9. doi: 10.1109/TBME.2009.2037492. Epub 2010 Feb 5.

  PMID: 20142157 BACKGROUND

• Lipponen JA, Kemppainen J, Karjalainen PA, Laitinen T, Mikola H, Karki T, Tarvainen MP. Dynamic estimation of cardiac repolarization characteristics during hypoglycemia in healthy and diabetic subjects. Physiol Meas. 2011 Jun;32(6):649-60. doi: 10.1088/0967-3334/32/6/003. Epub 2011 Apr 20.

  PMID: 21508439 BACKGROUND

• Lipponen JA, Tarvainen MP. Principal component model for maternal ECG extraction in fetal QRS detection. Physiol Meas. 2014 Aug;35(8):1637-48. doi: 10.1088/0967-3334/35/8/1637. Epub 2014 Jul 29.

  PMID: 25069651 BACKGROUND

• Meretoja A, Roine RO, Kaste M, Linna M, Juntunen M, Erila T, Hillbom M, Marttila R, Rissanen A, Sivenius J, Hakkinen U. Stroke monitoring on a national level: PERFECT Stroke, a comprehensive, registry-linkage stroke database in Finland. Stroke. 2010 Oct;41(10):2239-46. doi: 10.1161/STROKEAHA.110.595173. Epub 2010 Aug 26.

  PMID: 20798363 BACKGROUND

• Syvaoja S, Castren M, Mantyla P, Rissanen TT, Kivela A, Uusaro A, Jantti H. The feasibility of recognizing the heart rhythm with an automated external defibrillator from an area the size of a mobile phone. Eur J Emerg Med. 2016 Apr;23(2):102-7. doi: 10.1097/MEJ.0000000000000214.

  PMID: 25325408 BACKGROUND

• Tarvainen MP, Ranta-Aho PO, Karjalainen PA. An advanced detrending method with application to HRV analysis. IEEE Trans Biomed Eng. 2002 Feb;49(2):172-5. doi: 10.1109/10.979357.

  PMID: 12066885 BACKGROUND

• Tarvainen MP, Niskanen JP, Lipponen JA, Ranta-Aho PO, Karjalainen PA. Kubios HRV--heart rate variability analysis software. Comput Methods Programs Biomed. 2014;113(1):210-20. doi: 10.1016/j.cmpb.2013.07.024. Epub 2013 Aug 6.

  PMID: 24054542 BACKGROUND

• Thakor NV, Zhu YS, Pan KY. Ventricular tachycardia and fibrillation detection by a sequential hypothesis testing algorithm. IEEE Trans Biomed Eng. 1990 Sep;37(9):837-43. doi: 10.1109/10.58594.

  PMID: 2227970 BACKGROUND

• Zhang XS, Zhu YS, Thakor NV, Wang ZZ. Detecting ventricular tachycardia and fibrillation by complexity measure. IEEE Trans Biomed Eng. 1999 May;46(5):548-55. doi: 10.1109/10.759055.

  PMID: 10230133 BACKGROUND

• Kirchhof P, Benussi S, Kotecha D, Ahlsson A, Atar D, Casadei B, Castella M, Diener HC, Heidbuchel H, Hendriks J, Hindricks G, Manolis AS, Oldgren J, Alexandru Popescu B, Schotten U, Van Putte B, Vardas P. 2016 ESC Guidelines for the Management of Atrial Fibrillation Developed in Collaboration With EACTS. Rev Esp Cardiol (Engl Ed). 2017 Jan;70(1):50. doi: 10.1016/j.rec.2016.11.033. No abstract available. English, Spanish.

  PMID: 28038729 BACKGROUND

• Valiaho ES, Kuoppa P, Lipponen JA, Hartikainen JEK, Jantti H, Rissanen TT, Kolk I, Pohjantahti-Maaroos H, Castren M, Halonen J, Tarvainen MP, Santala OE, Martikainen TJ. Wrist Band Photoplethysmography Autocorrelation Analysis Enables Detection of Atrial Fibrillation Without Pulse Detection. Front Physiol. 2021 May 7;12:654555. doi: 10.3389/fphys.2021.654555. eCollection 2021.

  PMID: 34025448 DERIVED

• Santala OE, Lipponen JA, Jantti H, Rissanen TT, Halonen J, Kolk I, Pohjantahti-Maaroos H, Tarvainen MP, Valiaho ES, Hartikainen J, Martikainen T. Necklace-embedded electrocardiogram for the detection and diagnosis of atrial fibrillation. Clin Cardiol. 2021 May;44(5):620-626. doi: 10.1002/clc.23580. Epub 2021 Feb 25.

  PMID: 33629410 DERIVED

MeSH Terms

Conditions

Atrial Fibrillation; Tachycardia; Bradycardia

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Cardiac Conduction System Disease

Study Officials

• Tero J Martikainen, MD. PhD

  Kuopio University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 22, 2018
• First Posted: November 26, 2018
• Study Start: November 28, 2018
• Primary Completion: February 28, 2020
• Study Completion: July 31, 2020
• Last Updated: April 30, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

FI (1)