Portable Measurement Methods Combined With Artificial Intelligence in Detection of Atrial Fibrillation

NCT04917653 | Unknown

• 1 other identifier: KUH507T044
• Study Type: observational
• Target: 100
• 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 (AF) is the most common arrhythmia that increases the risk of thromboembolic complications, such as stroke. It may cause formation of thrombi in the left atrium with ensuing embolization in the cerebral and peripheral circulation. AF is often asymptomatic and paroxysmal. Thus, the diagnosis of AF is often challenging. A new onset AF is usually treated with cardioversion (CV), in which the abnormal rhythm is converted back to sinus rhythm (SR). However, a long-lasting AF (\>48 hours) is associated with risk of stroke. Therefore, the duration of AF needs to be known before a CV can be performed. This study evaluates the ability of novel customer-targeted heart measuring devices to detect rhythm change and short AF episodes. Moreover, novel biomarkers will be analyzed from the blood samples of AF patients and their suitability to estimate the duration of AF will be evaluated. 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; Sinus Rhythm

Outcome Measures

Primary Outcomes (2)

• Arrhythmia detection in rhythm change with single-lead ECG and wearable PPG

  Sensitivity and specificity of paroxysmal atrial fibrillation detection in short detection time frame during controlled rhythm change during cardioversion.

  2 hours

• Evaluation the various blood-based biomarkers in the estimation the duration of atrial fibrillation episode

  Kinematic models in various specific biomarkers during atrial fibrillation to predict the time domain of the arrhythmia.

  2 weeks

Study Arms (1)

Atrial fibrillation

Patients with recent-onset atrial fibrillation treated by cardioversion intervention. Intervention: Device: Heart rhythm monitoring with portable device. Biomarkers: Biomarker kinetics based on blood samples.

Device: Heart rhythm monitoring with wearable device; Other: Blood samples and biomarkers

Interventions

Heart rhythm monitoring with wearable 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.

Atrial fibrillation

Blood samples and biomarkers OTHER

Several blood samples will be collected during the study protocol in pre-defined times before and after the cardioversion intervention. Atrial peptides and cardiac troponins will be analyzed and kinetics estimated to predict the duration of early-onset AF period.

Atrial fibrillation

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 100 patients with early-onset atrial fibrillation treated by cardioversion during the treatment period will be recruited in the research.

You may qualify if:

• Patients with early-onset atrial fibrillation treated by cardioversion during the treatment period 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, 70210, Finland

RECRUITING

Related Publications (11)

• Lee SH, Jung JH, Choi SH, Lee N, Park WJ, Oh DJ, Rhim CY, Lee KH. Determinants of brain natriuretic peptide levels in patients with lone atrial fibrillation. Circ J. 2006 Jan;70(1):100-4. doi: 10.1253/circj.70.100.

  PMID: 16377932 BACKGROUND

• Clerk A, Cullingford TE, Fuller SJ, Giraldo A, Markou T, Pikkarainen S, Sugden PH. Signaling pathways mediating cardiac myocyte gene expression in physiological and stress responses. J Cell Physiol. 2007 Aug;212(2):311-22. doi: 10.1002/jcp.21094.

  PMID: 17450511 BACKGROUND

• Iakobishvili Z, Weissler A, Buturlin K, Goldenberg G, Strassberg B, Tur R, Hasdai D. High Sensitivity Cardiac Troponin T Levels after Elective Cardioversion for Atrial Fibrillation/Flutter. Isr Med Assoc J. 2015 Oct;17(10):607-11.

  PMID: 26665313 BACKGROUND

• Horjen AW, Ulimoen SR, Norseth J, Svendsen JH, Smith P, Arnesen H, Seljeflot I, Tveit A. High-sensitivity troponin I in persistent atrial fibrillation - relation to NT-proBNP and markers of inflammation and haemostasis. Scand J Clin Lab Invest. 2018 Sep;78(5):386-392. doi: 10.1080/00365513.2018.1481224. Epub 2018 Jun 22.

  PMID: 29933716 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

• 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

• 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

• 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 BACKGROUND

• Hartikainen S, Lipponen JA, Hiltunen P, Rissanen TT, Kolk I, Tarvainen MP, Martikainen TJ, Castren M, Valiaho ES, Jantti H. Effectiveness of the Chest Strap Electrocardiogram to Detect Atrial Fibrillation. Am J Cardiol. 2019 May 15;123(10):1643-1648. doi: 10.1016/j.amjcard.2019.02.028. Epub 2019 Feb 23.

  PMID: 30878151 BACKGROUND

• Valiaho ES, Kuoppa P, Lipponen JA, Martikainen TJ, Jantti H, Rissanen TT, Kolk I, Castren M, Halonen J, Tarvainen MP, Hartikainen JEK. Wrist band photoplethysmography in detection of individual pulses in atrial fibrillation and algorithm-based detection of atrial fibrillation. Europace. 2019 Jul 1;21(7):1031-1038. doi: 10.1093/europace/euz060.

  PMID: 31505594 BACKGROUND

• Rantula OA, Lipponen JA, Halonen J, Jantti H, Rissanen TT, Naukkarinen NS, Valiaho ES, Santala OE, Sedha J, Martikainen TJ, Hartikainen JEK. Photoplethysmography in recent-onset atrial fibrillation: automatic detection of rhythm change and burden. Eur Heart J Digit Health. 2025 May 23;6(4):723-732. doi: 10.1093/ehjdh/ztaf055. eCollection 2025 Jul.

  PMID: 40703141 DERIVED

MeSH Terms

Conditions

Atrial Fibrillation; Tachycardia; Bradycardia

Interventions

Wearable Electronic Devices; Blood Specimen Collection; Biomarkers

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Electrical Equipment and Supplies; Equipment and Supplies; Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques; Biological Factors

Study Officials

• Tero J Martikainen, MD. PhD

  Kuopion University Hospital, Anesthesiology and intensive care

  STUDY DIRECTOR

Central Study Contacts

Tero J Martikainen, MD. PhD

CONTACT

+358447175045; tero.martikainen@kuh.fi

Juha Hartikainen, Professor

CONTACT

+358 44 717 3945; juha.hartikainen@kuh.fi

Study Design

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

Study Record Dates

• First Submitted: June 2, 2021
• First Posted: June 8, 2021
• Study Start: June 7, 2021
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: November 22, 2022

Record last verified: 2022-11

Locations

FI (1)