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临床试验/NCT03962309
NCT03962309已完成不适用

Selection of People at Low Cardiovascular Risk: Development of an Inexpensive Pre-screening Algorithm Using Only Non-laboratory Measures. The SKIM Risk Study.

Mario Negri Institute for Pharmacological Research3 个研究点 分布在 1 个国家目标入组 2,699 人开始时间: 2020年12月18日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
2,699
试验地点
3
主要终点
To develop of a low cost CVD risk score

研究概览

简要总结

Early identification of individuals at high risk remains the cornerstone of primary cardiovascular prevention (CV). However, cardiovascular screening including people at low CV diseases (CVD) risk are too costly, time consuming and poorly effective in reducing incident CV events to be proposed at population level. Thus, innovative tools that allow to exclude low risk subjects in order to concentrate the relatively poor resources of NHS for primary prevention in high risk groups are needed. In this study, we will assess whether a new low cost strategy for CV risk stratification, based on non-laboratory measures, will allow to recognize low risk subjects who do not need further and expensive measures. To this end, we will take advantage of a General Practitioners (GPs) national network that will allow to work in the natural contest of primary prevention. If successful, the project will provide the basis for future, cost-effective prevention programs to be performed at national level.

详细描述

National, multicenter cross-sectional study.

The current study will be performed as part of Italian Cardiology Network implemented by the Italian Ministry of Health.

This study will be carried out with the collaboration with Study Center for Primary Care.

A random sample of subjects identified by the list of patients in charge of the participating GPs aged 40-70 years will be invited to a screening for the evaluation of their CV risk.

All patients who agree to participate in the study and sign the consent will complete a health self-assessment questionnaire which includes questions covering anthropometric, sociodemographics, personal and family health history, life style habits and aspects of the behavioral domain.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Cross Sectional

入排标准

年龄范围
40 Years 至 69 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Subjects aged 40-70 years

排除标准

  • Patients with previous cardiovascular events

结局指标

主要结局

To develop of a low cost CVD risk score

时间窗: 1 day

The low cost CVD risk score will be developed using variable obtainable only by the self-assessment questionnaire (low-cost) to identify persons at low CVD risk according to Progetto CUORE or SCORE risk estimation.

次要结局

  • Marital status(1 day)
  • Race(1 day)
  • Education status(1 day)
  • Employment status(1 day)
  • Clinical Family History(1 day)
  • Personal Clinical History(1 day)
  • The dietary habits(1 day)
  • Smoking habits(1 day)
  • Physical activity(1 day)
  • Behavioral domain(1 day)

研究者

发起方
Mario Negri Institute for Pharmacological Research
申办方类型
Other
责任方
Sponsor

研究点 (3)

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