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心肌梗死后强化预防项目的新技术:NET-IPP 试验的原理和设计。

New technologies for intensive prevention programs after myocardial infarction: rationale and design of the NET-IPP trial.

机构信息

Bremen Institute for Heart and Circulation Research at the Klinikum Links der Weser, Senator-Wessling-Str. 1, 28277, Bremen, Germany.

Medical Clinic II, Lübeck University Heart Center, Ratzeburger Allee 160, 23538, Lübeck, Germany.

出版信息

Clin Res Cardiol. 2021 Feb;110(2):153-161. doi: 10.1007/s00392-020-01695-w. Epub 2020 Jul 30.

Abstract

INTRODUCTION

Current health care data reveal suboptimal prevention in patients with coronary artery disease and an unmet need to develop effective preventive strategies. The New Technologies for Intensive Prevention Programs (NET-IPP) Trial will investigate if a long-term web-based prevention program after myocardial infarction (MI) will reduce clinical events and risk factors. In a genetic sub study the impact of disclosure of genetic risk using polygenic risk scores (PRS) will be assessed.

STUDY DESIGN

Patients hospitalized for MI will be prospectively enrolled and assigned to either a 12-months web-based intensive prevention program or standard care. The web-based program will include telemetric transmission of risk factor data, e-learning and electronic contacts between a prevention assistant and the patients. The combined primary study endpoint will comprise severe adverse cardiovascular events after 2 years. Secondary endpoints will be risk factor control, adherence to medication and quality of life. In a genetic sub study genetic risk will be assessed in all patients of the web-based intensive prevention program group by PRS and patients will be randomly assigned to genetic risk disclosure vs. no disclosure. The study question will be if disclosure of genetic risk has an impact on patient motivation and cardiovascular risk factor control.

CONCLUSIONS

The randomized multicenter NET-IPP study will evaluate for the first time the effects of a long-term web-based prevention program after MI on clinical events and risk factor control. In a genetic sub study the impact of disclosure of genetic risk using PRS will be investigated.

摘要

简介

目前的医疗保健数据显示,冠心病患者的预防措施不尽如人意,需要开发有效的预防策略。新的强化预防计划技术(NET-IPP)试验将研究心肌梗死后(MI)长期基于网络的预防计划是否会降低临床事件和风险因素。在一项遗传亚研究中,将评估使用多基因风险评分(PRS)披露遗传风险的影响。

研究设计

将前瞻性招募因 MI 住院的患者,并将其分配到为期 12 个月的基于网络的强化预防计划或标准护理中。基于网络的计划将包括危险因素数据的遥测传输、电子学习以及预防助手与患者之间的电子联系。综合主要研究终点将包括 2 年后严重不良心血管事件。次要终点将是危险因素控制、药物依从性和生活质量。在遗传亚研究中,将通过 PRS 评估基于网络的强化预防计划组中所有患者的遗传风险,并将患者随机分配到遗传风险披露与不披露。研究问题将是遗传风险的披露是否会影响患者的动机和心血管危险因素的控制。

结论

这项随机多中心 NET-IPP 研究将首次评估 MI 后长期基于网络的预防计划对临床事件和危险因素控制的影响。在遗传亚研究中,将研究使用 PRS 披露遗传风险的影响。

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