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Идёт набор NCT07684053

Digital Screening for Atrial Fibrillation to Prevent Stroke

Без фазы С лечением Atrial Fibrillation (Prevention of Stroke) Stroke

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: Smartphone-based digital atrial fibrillation screening and management pathway.
Кому может быть актуально
Состояния в реестре: Atrial Fibrillation (Prevention of Stroke), Stroke. Базовые параметры: от 65 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
Австрия
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Digital Screening for Atrial Fibrillation to Prevent Stroke: The Randomized Austrian Digital Heart Study

Обзор

The Austrian Digital Heart Study is a population-based, siteless, randomized, controlled digital trial testing whether a smartphone-based atrial fibrillation screening and management pathway reduces stroke hospitalizations compared with usual care. Adults aged 65 years or older in Austria are randomized to either a digital intervention using the 'Pulskontrolle' app or to usual care. The intervention includes smartphone-camera photoplethysmography for atrial fibrillation screening, confirmatory 7-day ECG patch monitoring in case of suspected atrial fibrillation, and digital education and management support. The primary outcome is hospitalization for stroke of any type within 48 months.

Подробное описание

Atrial fibrillation is common in older adults, often remains undetected, and is a major risk factor for stroke, heart failure, hospitalization, and death. Digital screening using smartphone-based photoplethysmography provides substantial benefits in detecting atrial fibrillation compared to usual care, but it remains unclear whether such screening improves clinical outcomes.

The Austrian Digital Heart Study tests a brand-independent digital atrial fibrillation screening and management pathway embedded in the Austrian public health-care system. Participants randomized to the intervention arm use the 'Pulskontrolle' smartphone application for repeated photoplethysmographic pulse-wave (PPG) recordings. If atrial fibrillation is suspected, confirmatory 7-day ECG patch monitoring is initiated. Participants with positive PPG receive structured digital information, telehealth support, and guideline-oriented management recommendations.

The control arm receives usual care without active app-based atrial fibrillation screening. The primary endpoint is hospitalization for stroke of any type within 48 months after randomization. Secondary outcomes include mortality, cardiovascular morbidity, bleeding, atrial fibrillation-related outcomes, health-care utilization, and health-economic endpoints.

Вмешательства

  • Устройство Smartphone-based digital atrial fibrillation screening and management pathway
    Participants randomized to the digital intervention arm receive access to a smartphone-based atrial fibrillation screening and management pathway. The intervention includes photoplethysmography-based pulse wave measurements using a CE-certified smartphone application, followed by confirmatory 7-day ECG patch monitoring in participants with abnormal findings suggestive of atrial fibrillation. Participants with suspected or confirmed atrial fibrillation receive structured digital information, adhe

Первичные конечные точки

  • Hospitalization for stroke of any type (ischemic or hemorrhagic) [Срок оценки: Up to 48 months]
Вторичные конечные точки (9)
  • Hospitalization for Ischemic stroke [Срок оценки: Up to 48 months]
  • Hospitalization for Hemorrhagic stroke [Срок оценки: Up to 48 months]
  • All-cause mortality [Срок оценки: Up to 48 months]
  • Cardiovascular mortality [Срок оценки: Up to 48 months]
  • Hospitalization for heart failure [Срок оценки: Up to 48 months]
  • The combination of hospitalization for stroke, hospitalization for heart failure and cardiovascular death. [Срок оценки: Up to 48 months]
  • Hospitalization for bleeding [Срок оценки: up to 48 months]
  • Fatal bleeding [Срок оценки: up to 48 months]
  • Cost and incremental cost effectiveness ratio [Срок оценки: Up to 48 months]

Критерии участия

Критерии включения

  • Age ≥ 65 years
  • Policyholder in Austria (active unique social insurance number)
  • Written electronic informed consent Exclusion Criteria

a) Currently treated with oral anticoagulation b) Cardiac implanted electronic device (CIED)

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Простое слепое
Основная цель
Скрининг

Центры проведения

Австрия · 1 центр
  • Department of Internal Medicine III, Medical University Innsbruck — Innsbruck

Идентификаторы

NCT: NCT07684053 · 1408/2025

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗