NCT03721601

Brief Summary

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 aim of the study is to assess the potential of chest strap as an ECG monitor, especially in arrhythmia detection by cardiologist and algorithm.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
220

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2017

Shorter than P25 for all trials

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2017

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2017

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

February 28, 2018

Completed
8 months until next milestone

First Posted

Study publicly available on registry

October 26, 2018

Completed
Last Updated

November 5, 2018

Status Verified

November 1, 2018

Enrollment Period

5 months

First QC Date

February 28, 2018

Last Update Submit

November 1, 2018

Conditions

StrokeAtrial Fibrillation

Keywords

atrial fibrillationstrokeatrial fibrillation screeningheart rate monitoring

Outcome Measures

Primary Outcomes (1)

  • Chest strap and PPG-device data quality

    Sensitivity and positive predictive value for the beat detection of chest strap ECG and PPG measurements and sensitivity and specificity for the atrial fibrillation detection

    5 minutes

Secondary Outcomes (1)

  • Chest strap and PPG-device data quality to enable arrhythmia diagnosis

    5 minutes

Study Arms (2)

Atrial fibrillation

Patients in atrial fibrillation as recorded by 3-lead Holter.

Device: Heart rate monitor chest strapDevice: Wrist band photoplethysmography

Sinus rhythm

Patients in sinus rhythm as recorded by 3-lead Holter.

Device: Heart rate monitor chest strapDevice: Wrist band photoplethysmography

Interventions

Heart rate monitor chest strapDEVICE

Simultaneously with 5min Holter recording, 5min recording of chest strap ECG.

Atrial fibrillationSinus rhythm
Wrist band photoplethysmographyDEVICE

Simultaneously with 5min Holter recording, 5min recording wrist band photoplethysmography.

Atrial fibrillationSinus rhythm

Eligibility Criteria

Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients in internal medicine emergency department, cardiology ward, cardiology examination unit

You may qualify if:

  • Atrial fibrillation in 12-lead ECG

You may not qualify if:

  • body mass index (BMI) over 33
  • implanted pacemaker device
  • lead ECG findings of left bundle branch block (LBBB) or right bundle branch block (RBBB)
  • medical condition requiring immediate treatment that would be delayed by the study measurements
  • serious infectious disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Helsinki University hospital

Helsinki, 00029, Finland

Location

North Carelia central hospital

Joensuu, 80210, Finland

Location

Kuopio University Hospital

Kuopio, 70029, Finland

Location

Related Publications (6)

  • 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: 28483832BACKGROUND

  • 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: 28038729BACKGROUND

  • 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: 28269032BACKGROUND

  • 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: 28916671BACKGROUND

  • 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: 29048522BACKGROUND

  • 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: 34025448DERIVED

MeSH Terms

Conditions

StrokeAtrial Fibrillation

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesArrhythmias, CardiacHeart DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Tero Martikainen, MD, PhD

    Kuopio University Hospital

    STUDY DIRECTOR

Study Design

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

Study Record Dates

First Submitted

February 28, 2018

First Posted

October 26, 2018

Study Start

May 1, 2017

Primary Completion

September 30, 2017

Study Completion

September 30, 2017

Last Updated

November 5, 2018

Record last verified: 2018-11

Data Sharing

IPD Sharing
Will not share

Locations

FI(3)