意大利主要预防心血管疾病的新型风险预测方法：CVRisk-IT试验（CVRisk-IT） (CVRISK-IT)
意大利主要预防心血管疾病的新型风险预测方法：CVRisk-IT试验
The CVRISK-IT study aims to evaluate the health benefit of measuring genetic and imaging risk information in men and women considered at 'low-to-moderate' or 'high' risk of developing cardiovascular diseases (CVD) in a randomized controlled trial in Italian primary care settings. Our primary objective is to answer a fundamental question in the prevention and prediction of CVD in Italy and globally: is there any benefit in including additional information (such as genetic and/or imaging data) in estimating risk, in conjunction with lifestyle advice and medical treatment for primary prevention of CVD?
As a key secondary objective of the CVRISK-IT study, the goal is to build a large bioresource with clinical information and biological samples to facilitate a new generation of discovery and translational research that will advance understanding of the genetic, molecular and behavioural determinants as well as mechanisms of multiple chronic diseases in the Italian population. By contributing to the Rete Cardiologica database and the BBDCARDIO biobank, the CVRISK-IT study will also serve as a cornerstone for future investigations into the development and testing of early diagnostic technologies and preventive (or 'personalised precision health') interventions for chronic diseases.
研究概览
详细说明
This multicenter, open randomized trial will investigate the effects of providing additional CVD risk information alongside personalised lifestyle advice and medical treatment in a primary prevention context across Italy. Healthy individuals aged 40 to 80 years, with no prior history of CVD or diabetes, will be recruited in two phases from the cohort of 17 participating IRCCS across Italy and affiliated enrolling centers. The population enrolled in this study consists of subjects who have never participated in other cardiovascular prevention studies of the Rete Cardiologica.
Phase 1 - Identification of the study population and development of the bioresource: various recruitment sources will be used, including institutions, primary care centres/services, government agencies, occupational health services, and volunteer organizations (e.g., blood donors). Participants will provide informed consent, a blood sample, and complete an electronic questionnaire. Approximately 30,000 individuals will be recruited and assessed using SCORE2/SCORE2-OP risk prediction models. Those identified as 'very high' risk will receive immediate medical treatment and will not proceed to phase 2.
Phase 2 - Randomization and novel risk prediction interventions: Participants identified as 'low-to-moderate' or 'high' CVD risk during phase 1 will be randomized, following a 2x2 factorial design into four groups within 1 week upon enrolment: a control group (no additional risk information), and three intervention groups (genetic, imaging-based and genetic + imaging-based risk information). The goal is to randomize around 12,000 participants in phase 2 (~3,000 per trial arm). All individuals will receive tailored lifestyle advice along with medical treatment based on their newly estimated CVD risk. The remaining 18,000 participants who won't proceed to phase 2 will still be involved in the study and contacted through a phone call follow-up with specialist at the 5◦ and 10◦ year.
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习地点
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Ancona、意大利
- 招聘中
- Irccs Inrca
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接触：
- Roberto Antonicelli, MD
- 电话号码：+390718003450
- 邮箱：r.antonicelli@inrca.it
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Genova、意大利
- 尚未招聘
- IRCCS San Martino
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接触：
- Pietro Ameri, MD
- 邮箱：pietro.ameri@unige.it
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Milan、意大利
- 招聘中
- IRCCS Ospedale San Raffaele
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接触：
- Paolo Camici, MD
- 电话号码：02 2643 8190/8191
- 邮箱：cvriskit@hsr.it
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Milan、意大利
- 招聘中
- IRCCS Auxologico Italiano
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接触：
- Gianfranco Parati, MD
- 电话号码：02-61911.1
- 邮箱：gianfranco.parati@unimib.it
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Milan、意大利
- 招聘中
- IRCCS Cardiologico Monzino
-
接触：
- Damiano Baldassarre, MD
- 电话号码：+39 02.58002369
- 邮箱：damiano.baldassarre@cardiologicomonzino.it
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Milan、意大利
- 尚未招聘
- IRCCS Fondazione Cà Granda- Policlinico Milano
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接触：
- Stefano Carugo, MD
- 邮箱：stefano.carugo@policlinico.mi.it
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Milan、意大利
- 尚未招聘
- IRCCS Istituto Clinico Humanitas
-
接触：
- Giuseppe Ferrante, MD
- 邮箱：giuseppe.ferrante@hunimed.eu
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Milan、意大利
- 招聘中
- IRCCS Mario Negri
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接触：
- Maria Carla Roncaglioni, MD
- 电话号码：0239014-501
- 邮箱：cvrisk-it_fase1@marionegri.it
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Milan、意大利
- 招聘中
- IRCCS Multimedica
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接触：
- Francesco Bandera, MD
- 电话号码：02.242091
- 邮箱：francesco.bandera@multimedica.it
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Naples、意大利
- 尚未招聘
- Irccs Synlab Sdn
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接触：
- Carlo Cavaliere, MD
- 邮箱：carlo.cavaliere@synlab.it
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Palermo、意大利
- 尚未招聘
- Irccs Ismett
-
接触：
- Manlio Cipriani, MD
- 邮箱：mcipriani@ismett.edu
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Pavia、意大利
- 尚未招聘
- IRCCS Istituti Clinici Scientifici Maugeri
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接触：
- Maria Teresa La Rovere, MD
- 邮箱：mariateresa.larovere@icsmaugeri.it
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Pavia、意大利
- 尚未招聘
- IRCCS Fondazione Policlinico San Matteo
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接触：
- Eloisa Arbustini, MD
- 邮箱：e.arbustini@smatteo.pv.it
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Pozzilli、意大利
- 尚未招聘
- IRCCS Neuromed
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接触：
- Maria Benedetta Donati, MD
- 邮箱：mariabenedetta.donati@neuromed.it
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Rome、意大利
- 尚未招聘
- IRCCS Fondazione Policlinico Gemelli
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接触：
- Giovanna Liuzzo, MD
- 邮箱：giovanna.liuzzo@policlinicogemelli.it
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Rome、意大利
- 尚未招聘
- IRCCS San Raffaele Roma
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接触：
- Massimo Volpe, MD
- 邮箱：massimo.volpe@sanraffaele.it
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San Donato Milanese、意大利
- 招聘中
- IRCCS Policlinico San Donato
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接触：
- Chiara Barberio, PhD
- 电话号码：02-52774838
- 邮箱：cvriskit@grupposandonato.it
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接触：
- Ambra Cerri, PhD
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首席研究员：
- Lorenzo Menicanti, MD
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副研究员：
- Emanuele Diangelantonio, MD
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Age: 40-80 years
- Apparently healthy individuals without previous medical history of CVD or diabetes (based on medical diagnosis)
- Participant recruitment arranged only at selected IRCCS (and associated Spokes) as part of the 'Rete Cardiologica'
- Participants must have signed the Informed Consent and Data Privacy Treatment forms
- Participants must have a personal e-mail address and internet connection
Exclusion Criteria:
- Age ≤40 or ≥80 years
- Individuals have previous medical history related to CVD (e.g., heart failure, congenital heart disorder, coronary heart disease) based on medical diagnosis
- Candidates have previously participated in clinical studies of 'Rete Cardiologica' (e.g., PREVITAL)
- Medical diagnosis of mental disorders
- Pregnancy based on self-reported information
- Previous history of type 1 or type 2 diabetes (based on medical diagnosis)
- Oncology patients (based on physician indication)
学习计划
研究是如何设计的？
设计细节
- 主要用途：预防
- 分配：随机化
- 介入模型：阶乘赋值
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
无干预：Control
No additional cardiovascular risk information/recommendation is provided to the subject other than SCORE2/SCORE2-OP results of phase I. Thereby, the control group does not undergo neither imaging nor genetic analysis. |
|
|
实验性的：Imaging
Subjects randomized in the imaging arm receive personalized recommendations on lifestyle and, if necessary, therapeutic intervention based on imaging data analysis (i.e., carotid ultrasound or calcium score) |
All individuals will receive tailored lifestyle advice along with medical treatment based on their newly estimated CVD risk. The control group will also receive lifestyle advice along with medical treatment based only on their CVD risk provided at the baseline visit during phase I. |
|
实验性的：Polygenic Risk Score (PRS)
Subjects randomized in this arm receive personalized recommendations on lifestyle and, if necessary, therapeutic intervention based on polygenic risk score (PRS) analysis obtained from blood samples collected at the baseline visit |
All individuals will receive tailored lifestyle advice along with medical treatment based on their newly estimated CVD risk. The control group will also receive lifestyle advice along with medical treatment based only on their CVD risk provided at the baseline visit during phase I. |
|
实验性的：Imaging and Polygenic Risk Score (PRS)
Subjects randomized in this arm receive personalized recommendations on lifestyle and, if necessary, therapeutic intervention based on both imaging data (e.g., carotid ultrasound and/or calcium score) and genetic analysis (e.g., PRS). |
All individuals will receive tailored lifestyle advice along with medical treatment based on their newly estimated CVD risk. The control group will also receive lifestyle advice along with medical treatment based only on their CVD risk provided at the baseline visit during phase I. |
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Change in CVD risk using SCORE2/SCORE2-OP
大体时间：12 months
|
The primary short-term outcome (i.e., 12 months after communication of the newly estimated CVD risk, following the randomisation step) is the change in CVD risk measured using SCORE2/SCORE2-OP risk prediction models. The CVD risk categories used to classify healthy people according to these scores are: 1) Low-to-moderate CVD risk: <50 years = <2.5 %; 50-69 years = <5%; ≥ 70 years = <7.5%. High CVD risk: <50 years = 2.5 to <7.5%; 50-69 years = 5 to <10%; ≥ 70 years 7.5 to <15%; Very high CVD risk: <50 years = ≥7.5%; 50-69 years = ≥10%; ≥ 70 years = ≥ 15%. |
12 months
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Change in cardiovascular modifiable risk factors
大体时间：12 months
|
Secondary short-term outcomes will include changes in objectively measured risk factors, such as cholesterol levels (i.e., total cholesterol, HDL cholesterol, LDL cholesterol, triglycerides) (mg/dl) |
12 months
|
|
Change in cardiovascular modifiable risk factors
大体时间：12 months
|
Secondary short-term outcomes will include changes in objectively measured risk factors, such as blood pressure which will be measured 3 times in a row, and its average calculated (mmHg) |
12 months
|
|
Change in cardiovascular modifiable risk factors
大体时间：12 months
|
Secondary short-term outcomes will include changes in objectively measured risk factors, such as smoking habits (e.g., switch from "usual smoker" to "not smoking anymore" categories) |
12 months
|
|
Change in CVD prevention-drugs prescription
大体时间：12 months
|
Secondary short-term outcomes will include changes in CVD prevention-drugs prescription with respect to the baseline visit |
12 months
|
|
Evaluation of participant's adherence to ESC recommendations
大体时间：12 months
|
By means of validated questionnaires, the assessment of participants' adherence to the lifestyle and dietary guidelines of the European Society of Cardiology (ESC) will be performed. If and where applicable, drugs prescription adherence will be evaluated as well as psychological outcomes |
12 months
|
其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
CVD events recording in long-term period
大体时间：5-10 years
|
The long-term outcomes will include the registration of CVD events in all enrolled participants in the long-term period (e.g., non-fatal myocardial infarction, acute coronary syndrome, percutaneous transluminal coronary angioplasty (PTCA), Coronary artery bypass grafting (CABG), non-fatal stroke), CVD mortality, and total mortality |
5-10 years
|
合作者和调查者
合作者
出版物和有用的链接
一般刊物
- Timmis A, Vardas P, Townsend N, Torbica A, Katus H, De Smedt D, Gale CP, Maggioni AP, Petersen SE, Huculeci R, Kazakiewicz D, de Benito Rubio V, Ignatiuk B, Raisi-Estabragh Z, Pawlak A, Karagiannidis E, Treskes R, Gaita D, Beltrame JF, McConnachie A, Bardinet I, Graham I, Flather M, Elliott P, Mossialos EA, Weidinger F, Achenbach S; Atlas Writing Group, European Society of Cardiology. European Society of Cardiology: cardiovascular disease statistics 2021. Eur Heart J. 2022 Feb 22;43(8):716-799. doi: 10.1093/eurheartj/ehab892.
- Di Angelantonio E, Piepoli M, Castelvecchio S, Barberio C, Chiarello C, Cerri A, Boveri S, Cardani R, Ambrogi F, Guelfi S, Baldassarre D, Colombo G, Amato M, Baetta R, Arbustini E, Liuzzo G, Kaptoge S, Severino A, Ferrante G, La Rovere MT, Parati G, Pengo MF, Latini R, Roncaglioni MC, Rigoni M, De Curtis A, Frati L, Ameri P, Camici PG, Volpe M, Menicanti L. Integrating genetic and imaging information to enhance cardiovascular risk stratification: rationale and design of the CVRISK-IT randomised controlled trial. Eur Heart J Qual Care Clin Outcomes. 2026 Mar 4:qcag032. doi: 10.1093/ehjqcco/qcag032. Online ahead of print.
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
关键字
其他研究编号
- CVRISK-IT
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
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