Novel Methods for Arrhythmia Detection: Chest Strap ECG and Wrist Band Photoplethysmography Compared to Holter-device for Atrial Fibrillation Detection
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 220
- Locations
- 3
- Primary Endpoint
- Chest strap and PPG-device data quality
Study Overview
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.
Detailed Description
Study design was a prospective case-control multicenter study at three sites in Finland. Study material was collected in internal medicine emergency departments, cardiology wards and cardiology examination units of participating hospitals, Kuopio University Hospital, Helsinki University Central Hospital, Meilahti and North Karelia Central Hospital, Joensuu. The study design was approved by University of Eastern Finland ethics committee (237/2017).
Study participants received a written information sheet about the study and were provided with an opportunity to ask questions concerning the study. A written informed consent was signed by the participants, including a permission to use patient's medical records.
Screening of study participants was made in participating hospitals from admitted patients in May - September 2017. The inclusion criteria for study group patients was atrial fibrillation confirmed by a doctor-interpreted 12-lead ECG, taken for medical reasons. Exclusion criteria were: body mass index (BMI) over 33; 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 in 12-lead ECG.
Demographics of study patients, including age, gender, previous medical history (as reported by patient or from patient medical records), length, weight and BMI, was recorded.
First, a 12-lead ECG was taken over a period of 10 seconds for rhythm confirmation, after which the ECG electrodes were removed. In the next step, altogether 5 wet electrodes were attached to patient to record ECG with Faros 360 Holter device (Mega Elektroniikka, Kuopio, Finland; device 1) to be used as golden standard for rhythm monitoring. Simultaneously a heart rate monitoring chest strap (Suunto Movesense, Suunto, Vantaa, Finland; device 2) and wrist band photoplethysmography (PPG) (Empatica E4, Empatica inc., Cambridge, United States) was applied. A total of 5 min recording was made.
Study Design
- Study Type
- Observational
- Observational Model
- Case Control
- Time Perspective
- Prospective
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Atrial fibrillation in 12-lead ECG
Exclusion Criteria
- •body mass index (BMI) over 33
- •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
Outcomes
Primary Outcomes
Chest strap and PPG-device data quality
Time Frame: 5 minutes
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
Secondary Outcomes
- Chest strap and PPG-device data quality to enable arrhythmia diagnosis(5 minutes)