Atrial Fibrillation Detection: 24 Hour Study (AFIB24h)

April 29, 2021 updated by: Tero Martikainen, Kuopio University Hospital

Chest Strap and PPG-device Compared to Holter-device for Atrial Fibrillation Detection: 24 Hour Study

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Study design:

Study design will be a prospective case-control study at Kuopio University Hospital (KUH) in Finland. Study material will be collected in internal medicine emergency department at KUH. The study design was approved by University of Eastern Finland ethics committee (347/2018).

Study participants will receive a written information sheet about the study and will be provided with an opportunity to ask questions concerning the study. A written informed consent will be signed by the participants, including a permission to use patient's medical records.

Screening of study participants will be made in participating hospitals from admitted patients in January 2018 - May 2019. The inclusion criteria for study group patients was atrial fibrillation confirmed by a doctor-interpreted 12-lead ECG . Exclusion criteria were: body mass index (BMI) over 35; implanted pacemaker device; 12-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. Control group consisted of patients with normal sinus rhythm (SR) in 12-lead ECG.

Measurement

Demographics of study patients, including age, gender, previous medical history (as reported by patient or from patient medical records), length and weight , will be recorded.

Before measurements, the patient will be asked to rest for at least 2 minutes, and lay still during the measurements. First, a 12-lead ECG will taken over a period of 10 seconds for rhythm confirmation for study grouping. In the next step, altogether 5 wet electrodes will be attached to patient to record ECG with Faros 360 Holter device (Mega Elektroniikka, Kuopio, Finland) to be used as golden standard for rhythm monitoring. Simultaneously a heart rate monitoring chest strap (Suunto Movesense, Suunto, Vantaa, Finland) will applied to chest approximately 2 cm below the lower end of sternum, according to manufacturer's instructions. PPG-device (Empatica Empatica ltd, Milan, Italy) will be connected to non-dominating wrist. A total of 24 hous recording will be made. The data from heart rate chest strap will sent via Bluetooth connection to study computer; the data from Faros Holter device was recorded to device´s internal memory card and transferred to analyzing software. The data collected was anonymized and ECG data from chest strap and Holter device was analyzed using MATLAB software.

The quality of the ECG-strip will be defined as good (no or only minor artefacts), average (artefacts but QRS complex and/or P-wave identifiable) or poor (major artefacts, no identifiable QRS complex and/or P-wave) by the cardiologist. The rhythm from the ECG-strips was divided to three categories: sinus rhythm, atrial fibrillation or other/inconclusive. The cardiologists also assessed the possibility to detect P-waves from the ECG-strips with SR (yes/no).

The study population will consisted of total 200 patients. According to the initial 12-lead ECG, total 100 patients with atrial fibrillation will be collected, and control group will consist of 100 patients with normal sinus rhythm.

Study Type

Observational

Enrollment (Actual)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Finland
    • East-Finland
      • Kuopio, East-Finland, Finland, 70029
        • Kuopio University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

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

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Atrial fibrillation
Patients with atrial fibrillation during measurements
Device: chest strap and PPG-device for monitoring the rhythm
chest strap and PPG-device for monitoring the rhythm during 24 hours for both groups (atrial fibrillation and sinus)
Other Names:
  • Suunto Movesense, Suunto, Vantaa, Finland
  • Empatica Empatica ltd, Milan, Italy
Sinus
Patients with sinus rhythm during measurements
Device: chest strap and PPG-device for monitoring the rhythm
chest strap and PPG-device for monitoring the rhythm during 24 hours for both groups (atrial fibrillation and sinus)
Other Names:
  • Suunto Movesense, Suunto, Vantaa, Finland
  • Empatica Empatica ltd, Milan, Italy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Chest strap data quality
Time Frame: 24 hours
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Data quality to enable arrhythmia diagnosis
Time Frame: 24 hours
Is photoplethysmographic measurement 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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kuopio University Hospital

Investigators

  • Study Director: Tero J Martikainen, PhD, Kuopio University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 9, 2018

Primary Completion (Actual)

May 31, 2020

Study Completion (Actual)

August 31, 2020

Study Registration Dates

First Submitted

December 20, 2017

First Submitted That Met QC Criteria

April 24, 2018

First Posted (Actual)

April 25, 2018

Study Record Updates

Last Update Posted (Actual)

May 4, 2021

Last Update Submitted That Met QC Criteria

April 29, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KUH507P001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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