Innovative Approaches for Personalised Cardiovascular Prevention

Официальное название

Innovative Approaches for Personalised Cardiovascular Prevention: Multicenter Randomised Controlled Study and Multidisciplinary Evaluation for a National Health Service (NHS) Implementation

Обзор

The goal of this clinical trial is to study innovative approaches for personalized primary preventive interventions for cardiovascular diseases (CVD) in the population. The main questions it aims to answer are: * efficacy and safety of the intervention * how to implement the interventions in the NHS Participants will be randomized in one of the four parallel arms: * standard of care; * genetic testing for cardiovascular genetic risk (through the cardiovascular Polygenic Risk Score or PRS); * digital intervention with a wearable device and its app; * digital intervention and genetic testing (PRS) The primary outcome we are going to evaluate is the efficacy of returning PRS information of CVD measured at baseline, alone or in combination with the use of a wearable device, on two endpoints: i) change in lifestyle pattern; ii) CVD risk profile modification. The postulated hypothesis is that the achievement of these endpoints is more likely in presence of at least one of the aforementioned interventions than among subjects who receive only traditional risk assessment at baseline, nor respect to subjects receiving traditional risk assessment plus adopting wearable devices.

Подробное описание

The trial will consist of four phases: an enrollment phase (T0), a disclosure visit three weeks later (T1), a follow-up visit five months after the disclosure visit (T2), and a final follow-up twelve months from enrollment (T3).

Once enrolled (T0), all participants will sign the informed consent form and undergo a comprehensive assessment, which includes:

* Completing a questionnaire on socioeconomic status, area of residence, and lifestyle, using the Life's Essential 8 tool \[1\]. The questionnaire will cover smoking status, alcohol consumption, dietary pattern, sleep pattern, and physical activity. Participants will be classified into favorable, intermediate, or unfavorable individual lifestyle patterns according to the Life's Essential 8 score. * Blood analysis will be performed to evaluate the lipid profile, including total cholesterol, LDL cholesterol, HDL cholesterol, and triglycerides.

At T1, a disclosure visit will be conducted to explain the assigned lifestyle category, share the results of the blood tests, and provide information on the expected interventions based on the assigned group.

The questionnaire will be administered at T0, T2, and T3. Blood analysis and cardiovascular profile evaluation will be conducted at both T0 and T3

Вмешательства

• Генная терапия PRS
  genetic test for the evaluation of PRS cardiovascular risk
• Устройство Digital app and wearable device
  a wearable device connected with its app

Первичные конечные точки

• Change in the Lifestyle Category [Срок оценки: 12 months]
• Modification of the Lipid Profile [Срок оценки: 12 months]

Критерии участия

Критерии включения

• high cardiovascular risk based on the SCORE 2 (between 2.5% and 10%)
• age between 40 and 69 years

Критерии исключения

• diabetes.
• familiar hypercholesterolemia.
• established CVD.

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Профилактика

Центры проведения

Италия · 1 центр

• Dipartimento Universitario di Scienze della Vita e Sanità Pubblica — Roma

Публикации

• Lloyd-Jones DM, Allen NB, Anderson CAM, Black T, Brewer LC, Foraker RE, Grandner MA, Lavretsky H, Perak AM, Sharma G, Rosamond W; American Heart Association. Life's Essential 8: Updating and Enhancing the American Heart Association's Construct of Cardiovascular Health: A Presidential Advisory From the American Heart Association. Circulation. 2022 Aug 2;146(5):e18-e43. doi: 10.1161/CIR.000000000000 PMID 35766027

Идентификаторы

NCT: NCT05883878 · 5506

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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