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Набор по приглашению NCT07154303

Testing the Performance of Smartphones and Their Accessories in Detecting Irregularly Irregular Heart Rhythm

— Наблюдательное Atrial Fibrillation (AF)

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Computer algorithms.
Кому может быть актуально
Состояния в реестре: Atrial Fibrillation (AF). Базовые параметры: от 22 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Китай
Следующий шаг
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Официальное название

Smartphone-Based Use of Phonocardiography, Electrocardiography Accessory, and/or Facial Photoplethysmography to Detect Atrial Fibrillation: Diagnostic Performance Study

Обзор

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.

Подробное описание

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.

Вмешательства

  • Диагностический тест 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.

Первичные конечные точки

  • Differentiation of Atrial Fibrillation from Sinus Rhythm in Heart Sound Recordings [Срок оценки: Day 0]
Вторичные конечные точки (4)
  • Differentiation of Atrial Fibrillation from Sinus Rhythm in Heart Sound Recordings [Срок оценки: Day 0]
  • Differentiation of Atrial Fibrillation from Sinus Rhythm in 1-Lead ECG Signals [Срок оценки: Day 0]
  • Differentiation of Atrial Fibrillation from Sinus Rhythm in PCG and 1-Lead ECG Signals [Срок оценки: Day 0]
  • Differentiation of Atrial Fibrillation from Sinus Rhythm in Facial Photoplethysmography Signals [Срок оценки: Day 0]

Критерии участия

Критерии включения

  • 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

Критерии исключения

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)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Дизайн исследования

Модель наблюдения
Случай-контроль

Центры проведения

Китай · 1 центр
  • Queen Mary Hospital — Гонконг

Идентификаторы

NCT: NCT07154303 · AUSC/ECG/rPPG-AF · UW 24-763

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗