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Идёт набор NCT07103057

VIZ ACCESS HCM - Multi-Site Registry

— Наблюдательное Hypertrophic Cardiomyopathy

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: Viz HCM.
Кому может быть актуально
Состояния в реестре: Hypertrophic Cardiomyopathy. 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
США
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

ACCESS HCM: Real World Evidence for Artificial-Intelligence-assisted Screening and Access to Care for HCM - A Multi-Site Registry

Обзор

To describe the clinical, economic, and population characteristics of newly diagnosed, previously diagnosed, and suspected patients evaluated by Viz HCM. HCM is underdiagnosed in the community and AI algorithms have been developed as screening tools. However, it is not well understood how to best integrate AI screening tools and their potential impact.

Вмешательства

  • Устройство Viz HCM
    Viz HCM is a Software as a Medical Device (SaMD) intended to receive 12-lead ECG recordings collected as part of a routine clinical assessment and analyze them in parallel to the standard of care. The device uses a machine learning based algorithm to analyze 12-lead ECGs and identify ECGs with suspected HCM.

Первичные конечные точки

  • Clinical characteristics of Viz HCM AI screening on HCM diagnosis [Срок оценки: Up to 3 years]
  • Clinical characteristics of Viz HCM AI screening on medical workup. [Срок оценки: Up to 3 years]
  • Clinical characteristics of Viz HCM AI screening on treatment plans. [Срок оценки: Up to 3 years]
  • Clinical characteristics of Viz HCM AI screening on closed care pathways [Срок оценки: Up to 3 years]
  • Population evaluation for access to care by socioeconomic status at the time of diagnosis. [Срок оценки: Up to 3 years]
  • Population evaluation for access to care by clinical stage of HCM at time of diagnosis. [Срок оценки: Up to 3 years]
  • Healthcare utilization and health economic outcomes- medical clinic visits [Срок оценки: Up to 3 years]
  • Health economics outcome as captured by associated testing modalities [Срок оценки: Up to 3 years]
  • Health economics outcome as captured by hospitalization data [Срок оценки: Up to 3 years]
  • Health economics outcome as captured by ICD placement data [Срок оценки: Up to 3 years]
Вторичные конечные точки (3)
  • Implementation science - percentage of alerts viewed [Срок оценки: Up to 2 years]
  • Implementation science - number of active users over time [Срок оценки: Up to 2 years]
  • Implementation science - reasons for user-indicated actions, where documented [Срок оценки: Up to 2 years]

Критерии участия

All Cohorts

  • Patients aged 18+ years at time of arrival to healthcare facility
  • Patients with a resting 12-lead digital electrocardiogram (ECG) that is flagged by Viz HCM for HCM suspicion

Additional cohort-specific criteria:

Cohort 1 - Newly Diagnosed Patients

  • Patients have been diagnosed with HCM after the Viz HCM implementation
  • Written informed consent is obtained prior to data collection

Cohort 2 - Previously Diagnosed Patients ● Prior diagnosis of HCM as evidenced by clinical diagnosis documentation prior to Viz HCM implementation

Cohort 3 - Suspected and Not Diagnosed Patients

● Patients did not receive sufficient clinical workup for HCM diagnosis confirmation

Cohort 4 - Unlikely HCM ● Patient ECG moved to 'Unlikely HCM' group within Viz by site study staff following HCM alert review

Cohort 5 - Alerts Not Reviewed

● HCM alert not reviewed by site study staff during study enrollment period

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

США · 3 центра
  • Emory University — Atlanta
  • North Shore University Health System — Evanston
  • Thomas Jefferson University — Philadelphia

Идентификаторы

NCT: NCT07103057 · Viz-HCM-10

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗