Идёт набор NCT07284550

Smartphone Based Digital Screening for Aortic Valve Stenosis

— Наблюдательное Aortic Valve Stenosis Artifical Intelligence

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 signal acquisition.
Кому может быть актуально: Состояния в реестре: Aortic Valve Stenosis, Artifical Intelligence. Базовые параметры: от 18 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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Обзор

Heart valve diseases are among the most serious cardiovascular conditions in older age. One of the most common forms is aortic valve stenosis, a narrowing of the valve opening between the left ventricle and the main artery. As the valve becomes tighter, the heart must work harder and harder to pump blood through the body. This process often develops slowly over many years and initially causes no clear symptoms. As a result, the condition is frequently detected only in advanced stages, when warning signs such as shortness of breath, chest pain, or dizziness appear. Without treatment, aortic valve stenosis can become life-threatening. If detected early, however, very effective treatment options are available today. Up to now, the disease has been reliably diagnosed mainly through echocardiography. Yet this method is complex, costly, and requires specialized medical staff. A simple, affordable, and broadly accessible screening option does not yet exist. The interdisciplinary clinical research project explores whether conventional smartphones could fill this gap. Almost all modern devices are equipped with sensors such as microphones, accelerometers, and gyroscopes. These can capture both heart sounds and subtle vibrations of the chest. The research team is investigating whether reliable diagnostic information for the diagnosis of aortic valve stenosis can be extracted from such recordings. To achieve this, the signals are processed with newly developed methods and analyzed using artificial intelligence. For the study, several hundred patients with and without valve disease will be examined. The smartphone results will be compared with established diagnostic standards, particularly echocardiography, to test accuracy and reliability. If successful, the approach could enable a straightforward, digital heart check at home using nothing more than a conventional smartphone. Such a tool would provide an accessible, low-cost, and widely available method for early detection, helping more people receive timely and potentially life-saving treatment.

Вмешательства

Диагностический тест Smartphone-based signal acquisition
To enable the study, we have already developed a pipeline from smartphone-based signal acquisition to secure signal upload. This will be followed by analysis of the microphone, accelerometer and gyroscope data and development of algorithms based on to-be-defined signal features.

Первичные конечные точки

Sensitivity and specificity of a smartphone-derived algorithm for detecting moderate-to-severe aortic stenosis (AVA ≤ 1.5 cm²), using echocardiography as the reference standard [Срок оценки: At the baseline study visit (after completion of smartphone and echocardiographic assessments)]

Вторичные конечные точки (4)

Quality of smartphone-acquired cardiac signals, measured by signal-to-noise ratio (SNR) [Срок оценки: At the baseline study visit]
Agreement between smartphone-derived aortic stenosis classification and echocardiographic grading, measured by Cohen's kappa coefficient [Срок оценки: At the baseline study visit]
Area under the receiver operating characteristic curve (AUROC) of the smartphone-based algorithm for detecting moderate-to-severe aortic stenosis [Срок оценки: At the baseline study visit]
Incidence of major adverse cardiac and cerebrovascular events (MACCE) [Срок оценки: Up to 12 months after the baseline study visit]

Критерии участия

The following inclusion and exclusion criteria will be used for training, validation and test sets:

Inclusion criteria for group I (moderate to severe AS):

Moderate to severe AS defined as AVA ≤ 1.5cm² in echocardiographic assessment
No other significant VHD, valvular prosthesis, pacemaker or congenital heart defect
Documented echocardiography as part of routine clinical practice no older than 90 days
Patient age ≥ 18 years
Provided written informed consent

Inclusion criteria for group II:

No significant VHD, valvular prosthesis, pacemaker or congenital heart defect
Documented echocardiography as part of routine clinical practice no older than 90 days
Patient age ≥ 18 years
Provided written informed consent

Exclusion criteria (applicable for all groups):