Идёт набор NCT06670677

Evaluation of the Clinical Benefit of the Aktiia Blood Pressure Monitoring for Early Awareness of Hypertension and Prediction of Cardiovascular Risk

— Наблюдательное Hypertension Cardiovascular Risk Blood Pressure Check (Hypertension Screening)

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: Lifestyle survey completion, Unlimited on-demand blood pressure measurements with G2C, Continual blood pressure measurements with G1.
Кому может быть актуально: Состояния в реестре: Hypertension, Cardiovascular Risk, Blood Pressure Check (Hypertension Screening). Базовые параметры: 21 лет — 85 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: Швейцария, Великобритания
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

OBPM_FORESEE2024: Evaluation of the Clinical Benefit of the Aktiia Blood Pressure Monitoring for Early Awareness of Hypertension and Prediction of Cardiovascular Risk in a Multi-ethnic European Population: an Observational Cohorts' Study

Обзор

Because Aktiia S.A. has been the first-ever company to put in the market an Optical Blood Pressure Monitoring device, there is a need for Aktiia S.A. to correlate for the first time continual Blood Pressure monitoring and the evolution of environmental and health factors to improve hypertension management.

Подробное описание

ARM 1:

N1\~ 3'300 subjects.

Research participants are Aktiia G1 users with Android operating system, i.e. individuals who already purchased the Aktiia G1 device out of the context of the study, located in Switzerland, Germany or UK, and owning a smartphone with Android operating system. ARM 1 research participants are asked to:

* For the next 10 years: wear their 24/7 Aktiia G1 device continuously as they would outside the context of the research project, * For the next 10 years, starting at their inclusion in the research project and every 6 months thereafter: fill in an online survey on their lifestyle- health- socioeconomic environment. * Additionally, once the Aktiia One App is released and for the next 10 years: * Take an on-demand measurement with the Aktiia G2C feature (finger measurement) while seated.

ARM 2:

N2\~ 6'600 subjects.

Research participants are Aktiia G1 users with iOS operating system, i.e. individuals who already purchased the Aktiia G1 device out of the context of the study, located in Switzerland, Germany or UK, and owning a smartphone with iOS operating system. ARM 2 research participants are asked to:

* For the next 10 years: wear their 24/7 Aktiia G1 device continuously as they would outside the context of the research project, * For the next 10 years, starting at their inclusion in the research project and every 6 months thereafter: fill in an online survey on their lifestyle- health- socioeconomic environment. The completion of a survey lasts 5min maximum. * Additionally, once the Aktiia One App is released and for the next 10 years: * Take an on-demand measurement with the Aktiia G2C feature (finger measurement) while seated.

ARM 3:

N3\~ 5'000 subjects.

Research participants are non-Aktiia-G1 users (they do not own an Aktiia G1 device at their inclusion in the study), located in Switzerland, Germany or UK, and owning a smartphone with either iOS or Android operating system. ARM 3 research participants are asked to:

* For the next 10 years, starting at their inclusion in the research project and every 6 months thereafter: fill in an online survey on their lifestyle- health- socioeconomic environment. The completion of a survey lasts 5min maximum. * At their inclusion in the study: download the Aktiia One App to access G2C functionality with on-demand measurements at fingertip using the smartphone's camera. * For the next 10 years, starting at their inclusion in the research project and thereafter:

* Take unlimited on-demand measurements with the Aktiia G2C feature.

Вмешательства

Другое Lifestyle survey completion
For the next 10 years, starting at their inclusion in the research project and every 6 months thereafter: fill in an online survey on their lifestyle- health- socioeconomic environment. The completion of a survey lasts 5min maximum.
Другое Unlimited on-demand blood pressure measurements with G2C
For the next 10 years: take unlimited on-demand measurements with the Aktiia G2C feature (finger measurement) while seated
Другое Continual blood pressure measurements with G1
For the next 10 years: wear their 24/7 Aktiia G1 device continuously as they would outside the context of the research project.

Первичные конечные точки

Multivariate models relating data from 24/7 Aktiia the G1 device continual BP monitoring with sociodemographic - lifestyle - and health factors [Срок оценки: 10 years]

Вторичные конечные точки (1)

Global scale projections of the benefit of the early awareness of hypertension with the spot-check Aktiia G2C device at the fingertip [Срок оценки: 10 years]

Критерии участия

Критерии включения

Adult subjects aged 21 to 85 years old
Subjects living in Switzerland, Germany or in the UK
Subjects that are:

Aktiia users owning a smartphone with either iOS or Android operating system (ARMs 1 and 2); or Aktiia non-users owning a smartphone with iOS or Android operating system (ARM 3)

Subjects agreeing to follow the study procedures.

Критерии исключения

Subjects suffering from sustained cardiac arrhythmias that can lead to weak or unstable pressure pulses including resting tachycardia (heart rate at rest > 120bpm) and atrial fibrillation;
Subjects suffering from pathologies that systematically reduce peripheral perfusion including Raynaud's disease, diabetes, renal dysfunctions (eGFR < 30mL / min / 1.73 m2), untreated hyper-/ hypothyroidism, pheochromocytoma, or arteriovenous fistula;
Subjects suffering from polyneuropathy;
on pregnant women;
Subjects with damaged / injured skin at the wrists (for bracelet measurements) or at index fingers (for camera measurements)
Subjects with amputated index fingers (for camera measurements) or amputated upper limb;
Subjects below 21 years old and above 85 years old.

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

Здоровые добровольцы: Да