Testing the Performance of Smartphones and Their Accessories in Detecting Irregularly Irregular Heart Rhythm
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Computer algorithms.
- Who it may be relevant to
- Registry conditions: Atrial Fibrillation (AF). Basic parameters: from 22 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Smartphone-Based Use of Phonocardiography, Electrocardiography Accessory, and/or Facial Photoplethysmography to Detect Atrial Fibrillation: Diagnostic Performance Study
Overview
The purpose of this 4-in-1 observational study is to test the performance of artificial intelligences (AIs) in distinguishing irregularly irregular heart rhythm called atrial fibrillation (AF) from normal heart rhythm using physiological signals collected by smartphones' built-in hardware and/or external accessories. Participants will: * Have their weight, height, resting heart rate and blood pressures measured * Have 12-lead electrocardiogram (ECG) of their heart electrical activities recorded * Have their heart sounds and 1-lead ECG recorded from their chest, and optical-based blood flow data (photoplethysmography or PPG) and 1-lead ECG recorded from their fingers using smartphones' built-in microphone, camera, and/or external accessories * Optionally have their optical-based blood flow data recorded from their face using smartphones' built-in camera (remote PPG or rPPG). The researchers will also create a database containing the physiological signals collected in this study along with the participants' medically relevant information to help train and test future AIs for medical applications.
Detailed description
4 observational studies have been combined into 1 observational study to share the same pool of participants. These 4 studies are designated as AUSC-AF, ECG-AF, AUSC+ECG-AF, and rPPG-AF corresponding to the signal modality/modalities used for AF detection (see outcome measures) and designated as AUSC/ECG/rPPG-AF when combined as 1 study.
Interventions
- Diagnostic test Computer algorithms
Computer algorithms that are designed to perform heart sound, electrocardiography (ECG), and/or facial photoplethysmography (rPPG) analysis on data collected from smartphone's internal hardware and/or external accessories.
Primary outcome measures
- Differentiation of Atrial Fibrillation from Sinus Rhythm in Heart Sound Recordings [Time frame: Day 0]
Secondary outcome measures (4)
- Differentiation of Atrial Fibrillation from Sinus Rhythm in Heart Sound Recordings [Time frame: Day 0]
- Differentiation of Atrial Fibrillation from Sinus Rhythm in 1-Lead ECG Signals [Time frame: Day 0]
- Differentiation of Atrial Fibrillation from Sinus Rhythm in PCG and 1-Lead ECG Signals [Time frame: Day 0]
- Differentiation of Atrial Fibrillation from Sinus Rhythm in Facial Photoplethysmography Signals [Time frame: Day 0]
Eligibility criteria
Inclusion criteria
- Age: ≥22 years (adult)
- Patients who have one of the following:
- Permanent atrial fibrillation, or
- Long-standing persistent atrial fibrillation (12 months or longer), or
- Confirmed 12-lead ECG diagnosis for persistent atrial fibrillation (> 7 days) or sinus rhythm within 12 months at the time of their normal attendance at the hospital
Exclusion criteria
Any of the following:
- Implanted active medical devices in the torso, such as pacemakers and defibrillators
- Patients without atrial fibrillation who have another arrhythmia
- Completely missing one or more limbs, or missing any hand
- Disability in using their hands or arms
- Lack of both index fingers, or all fingers in any hand
- Both index fingers with any of the following characteristics:
- Tattooed/inked
- Reduced blood flow in the fingertip (e.g. perniosis or callus formation)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Study design
- Observational model
- Case-control
Study locations
China · 1 center
- Queen Mary Hospital — Hong Kong
Identifiers
NCT: NCT07154303 · AUSC/ECG/rPPG-AF · UW 24-763