Atrial Fibrillation Detection: 24 Hour Study

NCT03507335 | Completed DMC

• 1 other identifier: KUH507P001
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Aims Approximately 20-25% of strokes are of cardioembolic origin, atrial fibrillation (AF) being a significant cause of cardioembolic strokes. AF is often symptomless and intermittent, making its detection a clinical challenge. Currently the golden standard for diagnosis of AF is by 12-lead electrocardiogram (ECG) or any other ECG-strip. The primary aim of the study is to assess the potential of chest strap as an ECG monitor especially in arrhythmia detection by cardiologist and algorithm. The secondary aim is to assess potential of photoplethysmography (PPG) based device for arrhythmia detection.

Conditions

Arrhythmia Atrial; Stroke

Keywords

Arrhythmia Atrial; heart rate monitoring; stroke; atrial fibrillation

Outcome Measures

Primary Outcomes (1)

• Chest strap data quality

  Is chest strap ECG non-inferior or superior for the atrial fibrillation detection as compared to Holter recording. Measures for determining outcome; sensitivity and specificity for the atrial fibrillation detection.

  24 hours

Secondary Outcomes (1)

• Data quality to enable arrhythmia diagnosis

  24 hours

Study Arms (2)

Atrial fibrillation

Patients with atrial fibrillation during measurements

Device: chest strap and PPG-device for monitoring the rhythm

Sinus

Patients with sinus rhythm during measurements

Device: chest strap and PPG-device for monitoring the rhythm

Interventions

chest strap and PPG-device for monitoring the rhythm DEVICE

chest strap and PPG-device for monitoring the rhythm during 24 hours for both groups (atrial fibrillation and sinus)

Also known as: Suunto Movesense, Suunto, Vantaa, Finland, Empatica Empatica ltd, Milan, Italy

Atrial fibrillation; Sinus

Eligibility Criteria

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

Study Population

Study material will be collected in internal medicine emergency department of KUH

You may qualify if:

• Atrial fibrillation in 12-lead ECG and admission to hospital (n=50) Sinus rhythm in 12-lead ECG and admission to hospital (n=50)

You may not qualify if:

• BMI\>35
• LBBB
• RBBB
• medical condition requiring immediate treatment
• serious infectious disease

Sponsors & Collaborators

• Kuopio University Hospital: lead

Study Sites (1)

Kuopio University Hospital

Kuopio, East-Finland, 70029, Finland

Location

Related Publications (7)

• 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, Popescu BA, Schotten U, Van Putte B, Vardas P, Agewall S, Camm J, Baron Esquivias G, Budts W, Carerj S, Casselman F, Coca A, De Caterina R, Deftereos S, Dobrev D, Ferro JM, Filippatos G, Fitzsimons D, Gorenek B, Guenoun M, Hohnloser SH, Kolh P, Lip GY, Manolis A, McMurray J, Ponikowski P, Rosenhek R, Ruschitzka F, Savelieva I, Sharma S, Suwalski P, Tamargo JL, Taylor CJ, Van Gelder IC, Voors AA, Windecker S, Zamorano JL, Zeppenfeld K. 2016 ESC Guidelines for the management of atrial fibrillation developed in collaboration with EACTS. Europace. 2016 Nov;18(11):1609-1678. doi: 10.1093/europace/euw295. Epub 2016 Aug 27. No abstract available.

  PMID: 27567465 BACKGROUND

• Nemati S, Ghassemi MM, Ambai V, Isakadze N, Levantsevych O, Shah A, Clifford GD. Monitoring and detecting atrial fibrillation using wearable technology. Annu Int Conf IEEE Eng Med Biol Soc. 2016 Aug;2016:3394-3397. doi: 10.1109/EMBC.2016.7591456.

  PMID: 28269032 BACKGROUND

• Thijs V. Atrial Fibrillation Detection: Fishing for An Irregular Heartbeat Before and After Stroke. Stroke. 2017 Oct;48(10):2671-2677. doi: 10.1161/STROKEAHA.117.017083. Epub 2017 Sep 15. No abstract available.

  PMID: 28916671 BACKGROUND

• Mairesse GH, Moran P, Van Gelder IC, Elsner C, Rosenqvist M, Mant J, Banerjee A, Gorenek B, Brachmann J, Varma N, Glotz de Lima G, Kalman J, Claes N, Lobban T, Lane D, Lip GYH, Boriani G; ESC Scientific Document Group. Screening for atrial fibrillation: a European Heart Rhythm Association (EHRA) consensus document endorsed by the Heart Rhythm Society (HRS), Asia Pacific Heart Rhythm Society (APHRS), and Sociedad Latinoamericana de Estimulacion Cardiaca y Electrofisiologia (SOLAECE). Europace. 2017 Oct 1;19(10):1589-1623. doi: 10.1093/europace/eux177. No abstract available.

  PMID: 29048522 BACKGROUND

• Freedman B, Camm J, Calkins H, Healey JS, Rosenqvist M, Wang J, Albert CM, Anderson CS, Antoniou S, Benjamin EJ, Boriani G, Brachmann J, Brandes A, Chao TF, Conen D, Engdahl J, Fauchier L, Fitzmaurice DA, Friberg L, Gersh BJ, Gladstone DJ, Glotzer TV, Gwynne K, Hankey GJ, Harbison J, Hillis GS, Hills MT, Kamel H, Kirchhof P, Kowey PR, Krieger D, Lee VWY, Levin LA, Lip GYH, Lobban T, Lowres N, Mairesse GH, Martinez C, Neubeck L, Orchard J, Piccini JP, Poppe K, Potpara TS, Puererfellner H, Rienstra M, Sandhu RK, Schnabel RB, Siu CW, Steinhubl S, Svendsen JH, Svennberg E, Themistoclakis S, Tieleman RG, Turakhia MP, Tveit A, Uittenbogaart SB, Van Gelder IC, Verma A, Wachter R, Yan BP; AF-Screen Collaborators. Screening for Atrial Fibrillation: A Report of the AF-SCREEN International Collaboration. Circulation. 2017 May 9;135(19):1851-1867. doi: 10.1161/CIRCULATIONAHA.116.026693.

  PMID: 28483832 RESULT

• Santala OE, Lipponen JA, Jantti H, Rissanen TT, Tarvainen MP, Laitinen TP, Laitinen TM, Castren M, Valiaho ES, Rantula OA, Naukkarinen NS, Hartikainen JEK, Halonen J, Martikainen TJ. Continuous mHealth Patch Monitoring for the Algorithm-Based Detection of Atrial Fibrillation: Feasibility and Diagnostic Accuracy Study. JMIR Cardio. 2022 Jun 21;6(1):e31230. doi: 10.2196/31230.

  PMID: 35727618 DERIVED

• Santala OE, Halonen J, Martikainen S, Jantti H, Rissanen TT, Tarvainen MP, Laitinen TP, Laitinen TM, Valiaho ES, Hartikainen JEK, Martikainen TJ, Lipponen JA. Automatic Mobile Health Arrhythmia Monitoring for the Detection of Atrial Fibrillation: Prospective Feasibility, Accuracy, and User Experience Study. JMIR Mhealth Uhealth. 2021 Oct 22;9(10):e29933. doi: 10.2196/29933.

  PMID: 34677135 DERIVED

MeSH Terms

Conditions

Stroke; Atrial Fibrillation

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Heart Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Tero J Martikainen, PhD

  Kuopio University Hospital

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief physician

Study Record Dates

• First Submitted: December 20, 2017
• First Posted: April 25, 2018
• Study Start: April 9, 2018
• Primary Completion: May 31, 2020
• Study Completion: August 31, 2020
• Last Updated: May 4, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

FI (1)