Набор скоро начнётся NCT06931288

Electronic Blood Pressure Monitor for Atrial Fibrillation Detection

Без фазы С лечением 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: Blood pressure monitor, Single-lead ECG.
Кому может быть актуально: Состояния в реестре: Atrial Fibrillation (AF). Базовые параметры: 60 лет — 125 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: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

Не всё понятно в терминах? Прочитайте наш гид для пациентов →

Официальное название

Study on the Effectiveness of Atrial Fibrillation Screening Using Electronic Blood Pressure Monitor With Atrial Fibrillation Detection Function

Обзор

Study name: Study on the Effectiveness of Atrial Fibrillation Screening Using Electronic Blood Pressure Monitor with Atrial Fibrillation Detection Function Objective: This study compares an electronic blood pressure monitor (BP77A1T, Omron Healthcare, Kyoto, Japan) with single-lead electrocardiography for atrial fibrillation detection in an elderly Chinese population. Study design: This study is a cluster-randomized and controlled trial. Study population: Men and women aged over 60 years meeting the inclusion/exclusion criteria. Randomization and treatment: Eligible centers as clusters will be randomly assigned to either the single-lead electrocardiography group or the electronic blood pressure monitor group for atrial fibrillation detection. Sample size: About 50 centers, at least 20,000 participants. Timeline: Participants enrollment are expected to be performed from May 2025 to July 2026. Organization: The Centre for Epidemiological Studies and Clinical Trials, Ruijin Hospital, Shanghai, China.

Подробное описание

Study name: Study on the Effectiveness of Atrial Fibrillation Screening Using Electronic Blood Pressure Monitor with Atrial Fibrillation Detection Function

Rationale: With the advancement of technology and the development of artificial intelligence, it has become possible to detect atrial fibrillation during routine blood pressure measurements. Previous studies have explored the accuracy of the blood pressure monitor for atrial fibrillation detection. However, the efficiency and adherence of using this device for large-scale population screening remain unknown.

Objective: This study compares an electronic blood pressure monitor (BP77A1T, Omron Healthcare, Kyoto, Japan) with single-lead electrocardiography for atrial fibrillation detection in an elderly Chinese population.

Study design: This study is a cluster-randomized and controlled trial. The eligible center as a cluster will be randomly assigned to either the single-lead electrocardiography group or the electronic blood pressure monitor group for atrial fibrillation detection.

Study population: Men and women aged over 60 years meeting the inclusion/exclusion criteria. Inclusion criteria included: 1) Signed and dated informed consent form. 2) Age ≥ 60 years. 3) Able to cooperate with atrial fibrillation screening, complete questionnaires, and communicate normally. The only exclusion criteria is severe communication problem.

Randomization and treatment: Eligible centers as clusters will be randomly assigned to either the single-lead electrocardiography group or the electronic blood pressure monitor group for atrial fibrillation detection. In the control group, a single-lead electrocardiography will be recorded for 30s with a handheld electrocardiography for atrial fibrillation detection. Each ECG rhythm strip will be reviewed and analyzed by a cardiologist from the research team. In the trial group, atrial fibrillation screening will be integrated into blood pressure measurements using the BP77A1T electronic blood pressure monitor (Omron Healthcare, Kyoto, Japan).

Sample size: About 50 centers, at least 20,000 participants.

Timeline: Participants enrollment are expected to be performed from May 2025 to July 2026.

Organization: The Centre for Epidemiological Studies and Clinical Trials, Ruijin Hospital, Shanghai, China.

Вмешательства

Устройство Blood pressure monitor
In the trial group, atrial fibrillation screening will be integrated into blood pressure measurements using the BP77A1T electronic blood pressure monitor (Omron Healthcare, Kyoto, Japan).
Устройство Single-lead ECG
In the control group, a single-lead ECG will be recorded for 30s with a handheld ECG for atrial fibrillation detection. Each ECG rhythm strip will be reviewed and analyzed by a cardiologist from the research team.

Первичные конечные точки

The difference in detection rates of atrial fibrillation between the blood pressure monitor and the single-lead ECG group. [Срок оценки: Baseline]

Вторичные конечные точки (1)

The difference in detection rates atrial fibrillation of between the blood pressure monitor and the single-lead ECG group among screening-positive participants. [Срок оценки: Baseline]

Критерии участия

Критерии включения

Signed and dated informed consent form.
Age ≥ 60 years.
Able to cooperate with atrial fibrillation screening, complete questionnaires, and communicate normally.