PDF(Pubmed)
Abstract：
UNASSIGNED: Cardiovascular diseases (CVDs) pose a significant global health challenge, necessitating innovative approaches for primary prevention. Personalized prevention, based on genetic risk scores (PRS) and digital technologies, holds promise in revolutionizing CVD preventive strategies. However, the clinical efficacy of these interventions requires further investigation. This study presents the protocol of the INNOPREV randomized controlled trial, aiming to evaluate the clinical efficacy of PRS and digital technologies in personalized cardiovascular disease prevention.
UNASSIGNED: The INNOPREV trial is a four-arm RCT conducted in Italy. A total of 1,020 participants, aged 40-69 with high 10-year CVD risk based on SCORE 2 charts, will be randomly assigned to traditional CVD risk assessment, genetic testing (CVD PRS), digital intervention (app and smart band), or a combination of genetic testing and digital intervention. The primary objective is to evaluate the efficacy of providing CVD PRS information, measured at baseline, either alone or in combination with the use of an app and a smart band, on two endpoints: changes in lifestyle patterns, and modification in CVD risk profiles. Participants will undergo a comprehensive assessment and cardiovascular evaluation at baseline, with follow-up visits at one, five, and 12 months. Lifestyle changes and CVD risk profiles will be assessed at different time points beyond the initial assessment, using the Life\'s Essential 8 and SCORE 2, respectively. Blood samples will be collected at baseline and at study completion to evaluate changes in lipid profiles. The analysis will employ adjusted mixed-effect models for repeated measures to assess significant differences in the data collected over time. Additionally, potential moderators and mediators will be examined to understand the underlying mechanisms of behavior change.
UNASSIGNED: As the largest trial in this context, the INNOPREV trial will contribute to the advancement of personalized cardiovascular disease prevention, with the potential to positively impact public health and reduce the burden of CVDs on healthcare systems. By systematically examining the clinical efficacy of PRS and digital interventions, this trial aims to provide valuable evidence to guide future preventive strategies and enhance population health outcomes.
UNASSIGNED: The INNOPREV trial is a four-arm RCT conducted in Italy. A total of 1,020 participants, aged 40-69 with high 10-year CVD risk based on SCORE 2 charts, will be randomly assigned to traditional CVD risk assessment, genetic testing (CVD PRS), digital intervention (app and smart band), or a combination of genetic testing and digital intervention. The primary objective is to evaluate the efficacy of providing CVD PRS information, measured at baseline, either alone or in combination with the use of an app and a smart band, on two endpoints: changes in lifestyle patterns, and modification in CVD risk profiles. Participants will undergo a comprehensive assessment and cardiovascular evaluation at baseline, with follow-up visits at one, five, and 12 months. Lifestyle changes and CVD risk profiles will be assessed at different time points beyond the initial assessment, using the Life\'s Essential 8 and SCORE 2, respectively. Blood samples will be collected at baseline and at study completion to evaluate changes in lipid profiles. The analysis will employ adjusted mixed-effect models for repeated measures to assess significant differences in the data collected over time. Additionally, potential moderators and mediators will be examined to understand the underlying mechanisms of behavior change.
UNASSIGNED: As the largest trial in this context, the INNOPREV trial will contribute to the advancement of personalized cardiovascular disease prevention, with the potential to positively impact public health and reduce the burden of CVDs on healthcare systems. By systematically examining the clinical efficacy of PRS and digital interventions, this trial aims to provide valuable evidence to guide future preventive strategies and enhance population health outcomes.
摘要：
■心血管疾病（CVDs）构成了重大的全球健康挑战，需要采取创新的初级预防方法。个性化预防,基于遗传风险评分(PRS)和数字技术，有望彻底改变CVD预防策略。然而,这些干预措施的临床疗效需要进一步研究.本研究提出了INNOPREV随机对照试验的方案，旨在评估PRS和数字技术在个性化心血管疾病预防中的临床疗效。
■INNOPREV试验是在意大利进行的四臂RCT。共有1,020人参加,根据SCORE2图表，年龄在40-69岁之间的10年心血管疾病风险较高，将被随机分配到传统的CVD风险评估中，基因检测（CVDPRS），数字干预（应用程序和智能乐队），或者基因检测和数字干预的结合。主要目标是评估提供CVDPRS信息的功效，在基线测量，单独或结合使用应用程序和智能乐队，在两个终点：生活方式的改变，和CVD风险概况的修改。参与者将在基线时进行全面评估和心血管评估，一次随访，五,和12个月。生活方式变化和心血管疾病风险状况将在初始评估之外的不同时间点进行评估。分别使用生活基本8和得分2。将在基线和研究完成时收集血液样品以评估脂质分布的变化。分析将采用调整后的混合效应模型进行重复测量，以评估随时间收集的数据的显着差异。此外,将检查潜在的主持人和调解员，以了解行为改变的潜在机制。
■作为这方面最大的试验，INNOPREV试验将有助于推进个性化心血管疾病预防，有可能对公共卫生产生积极影响，并减轻心血管疾病对医疗保健系统的负担。通过系统地检查PRS和数字干预的临床疗效，本试验旨在为指导未来的预防策略和提高人群健康结局提供有价值的证据.
■INNOPREV试验是在意大利进行的四臂RCT。共有1,020人参加,根据SCORE2图表，年龄在40-69岁之间的10年心血管疾病风险较高，将被随机分配到传统的CVD风险评估中，基因检测（CVDPRS），数字干预（应用程序和智能乐队），或者基因检测和数字干预的结合。主要目标是评估提供CVDPRS信息的功效，在基线测量，单独或结合使用应用程序和智能乐队，在两个终点：生活方式的改变，和CVD风险概况的修改。参与者将在基线时进行全面评估和心血管评估，一次随访，五,和12个月。生活方式变化和心血管疾病风险状况将在初始评估之外的不同时间点进行评估。分别使用生活基本8和得分2。将在基线和研究完成时收集血液样品以评估脂质分布的变化。分析将采用调整后的混合效应模型进行重复测量，以评估随时间收集的数据的显着差异。此外,将检查潜在的主持人和调解员，以了解行为改变的潜在机制。
■作为这方面最大的试验，INNOPREV试验将有助于推进个性化心血管疾病预防，有可能对公共卫生产生积极影响，并减轻心血管疾病对医疗保健系统的负担。通过系统地检查PRS和数字干预的临床疗效，本试验旨在为指导未来的预防策略和提高人群健康结局提供有价值的证据.
