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Atrial Fibrillation Detection: 24 Hour Study (AFIB24h)

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ClinicalTrials.gov Identifier: NCT03507335
Recruitment Status : Recruiting
First Posted : April 25, 2018
Last Update Posted : October 25, 2018
Sponsor:
Information provided by (Responsible Party):
Tero Martikainen, Kuopio University Hospital

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.


Condition or disease Intervention/treatment
Arrhythmia Atrial Stroke Device: chest strap and PPG-device for monitoring the rhythm

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 (237/2017).

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.


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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Chest Strap and PPG-device Compared to Holter-device for Atrial Fibrillation Detection: 24 Hour Study
Actual Study Start Date : April 9, 2018
Estimated Primary Completion Date : May 31, 2020
Estimated Study Completion Date : August 31, 2020

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Study material will be collected in internal medicine emergency department of KUH
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03507335


Contacts
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Contact: Tero J Martikainen, PhD +358447175045 tero.martikainen@kuh.fi
Contact: Helena Jäntti, PhD +358447174881 helena.jantti@kuh.fi

Locations
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Finland
Kuopio University Hospital Recruiting
Kuopio, East-Finland, Finland, 70029
Contact: Tero J Martikainen, PhD    +358447175045    tero.martikainen@kuh.fi   
Contact: Helena Jäntti, PhD    +358447174881    helena.jantti@kuh.fi   
Sponsors and Collaborators
Kuopio University Hospital
Investigators
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Study Director: Tero J Martikainen, PhD Kuopio University Hospital

Publications of Results:
Other Publications:

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Responsible Party: Tero Martikainen, Chief physician, Kuopio University Hospital
ClinicalTrials.gov Identifier: NCT03507335     History of Changes
Other Study ID Numbers: KUH507P001
First Posted: April 25, 2018    Key Record Dates
Last Update Posted: October 25, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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

Keywords provided by Tero Martikainen, Kuopio University Hospital:
Arrhythmia Atrial
heart rate monitoring
stroke
atrial fibrillation

Additional relevant MeSH terms:
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Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes