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Идёт набор NCT07502599

Fainting Detection And Early Warning In Syncope Evaluation Study (ARISE)

— Наблюдательное Orthostatic Hypotension Reflex Syncope

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: Wearable holter monitor, Wearable holter monitor.
Кому может быть актуально
Состояния в реестре: Orthostatic Hypotension, Reflex Syncope. 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

Fainting Detection And Early Warning In Syncope Evaluation Study

Обзор

To characterize the impact of orthostatic hypotension (OH) and Vasovagal syncope on signals measured using a wearable Holter monitor in the clinic and ambulatory setting. To evaluate the relationship of signals measured from the Holter monitor with reported symptom severity of orthostatic intolerance per standard data collection, analysis, and questionnaires.

Подробное описание

This is a non-randomized feasibility study that will enroll up to 40 participants that have undergone a previous autonomic reflex screen (ARS) assessment and were either diagnosed with OH or reflex syncope or considered to be control subjects for this study.

A minimum of 20 subjects diagnosed with reflex syncope; a maximum of 15 subjects diagnosed with OH syncope and a maximum of 15 control subjects will be enrolled. There will be one in person study visit and a 21 day follow up period per subject.

Вмешательства

  • Устройство Wearable holter monitor
    Participants will be fitted with a minimum of one wearable Holter monitor and up to 2 monitors, placed on the skin that measures physiologic signals. Participants will wear the monitor(s) for up approximately 21 days.
  • Устройство Wearable holter monitor
    Participants will be fitted with a minimum of one wearable Holter monitor and up to 2 monitors, placed on the skin that measures physiologic signals. Participants will wear the monitor(s) for up approximately 21 days.

Первичные конечные точки

  • Physiologic Signal Detection via wearable holter monitor [Срок оценки: From enrollment through the 21 day follow up period]
Вторичные конечные точки (1)
  • Physiologic Signal Detection via wearable holter monitor [Срок оценки: From enrollment through the 21 day follow up]

Критерии участия

Критерии включения

  • Willing and capable to provide informed consent
  • Age 18 or above
  • Previously underwent a clinically indicated ARS assessment without complications (including deep breathing, Valsalva maneuver, and tilt table testing).
  • Previously diagnosed with OH, Vasovagal syncope, OR control subjects assessed as normal, based on the ARS assessment. Participant enrollment shall be based on the type of diagnosis.
  • Willing to complete all required study activities.

Критерии исключения

  • Currently enrolled in another clinical trial that might interfere with data collection.
  • Subject is pregnant or planning to become pregnant during the study
  • Active Implantable Medical Device, e.g. cardiac implantable electronic devices, bladder stimulators, diaphragm stimulators, implantable neuro stimulator, implantable active monitoring devices, implantable active drug administration devices, etc.
  • Have a prosthetic cardiac valve or previously underwent cardiac valve surgery.
  • Known allergy to materials used in the study (adhesive, ECG electrodes)
  • Diagnosed with syncope due to cardiologic causes.
  • Have had a myocardial infarction in the previous 90 days
  • Have been diagnosed with tachycardia that requires current medical treatment
  • Have any contraindications for exercise testing, tilt table test, Valsalva maneuver test or deep breathing test (judged by the study Principal Investigator)

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 · 1 центр
  • Mayo Clinic Foundation — Rochester

Идентификаторы

NCT: NCT07502599 · C2232

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗