イタリアの心血管疾患の主要な予防のための新しいリスク予測アプローチ：CVRISK-IT試験（CVRISK-IT） (CVRISK-IT)
イタリアの心血管疾患の主要な予防のための新しいリスク予測アプローチ：CVRISK-IT試験
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.
調査の概要
詳細な説明
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.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究場所
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-
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Ancona、イタリア
- 募集
- Irccs Inrca
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コンタクト：
- Roberto Antonicelli, MD
- 電話番号：+390718003450
- メール：r.antonicelli@inrca.it
-
Genova、イタリア
- まだ募集していません
- IRCCS San Martino
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コンタクト：
- Pietro Ameri, MD
- メール：pietro.ameri@unige.it
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Milan、イタリア
- 募集
- IRCCS Ospedale San Raffaele
-
コンタクト：
- Paolo Camici, MD
- 電話番号：02 2643 8190/8191
- メール：cvriskit@hsr.it
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Milan、イタリア
- 募集
- IRCCS Auxologico Italiano
-
コンタクト：
- Gianfranco Parati, MD
- 電話番号：02-61911.1
- メール：gianfranco.parati@unimib.it
-
Milan、イタリア
- 募集
- IRCCS Cardiologico Monzino
-
コンタクト：
- Damiano Baldassarre, MD
- 電話番号：+39 02.58002369
- メール：damiano.baldassarre@cardiologicomonzino.it
-
Milan、イタリア
- まだ募集していません
- IRCCS Fondazione Cà Granda- Policlinico Milano
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コンタクト：
- Stefano Carugo, MD
- メール：stefano.carugo@policlinico.mi.it
-
Milan、イタリア
- まだ募集していません
- IRCCS Istituto Clinico Humanitas
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コンタクト：
- Giuseppe Ferrante, MD
- メール：giuseppe.ferrante@hunimed.eu
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Milan、イタリア
- 募集
- IRCCS Mario Negri
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コンタクト：
- Maria Carla Roncaglioni, MD
- 電話番号：0239014-501
- メール：cvrisk-it_fase1@marionegri.it
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Milan、イタリア
- 募集
- IRCCS Multimedica
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コンタクト：
- Francesco Bandera, MD
- 電話番号：02.242091
- メール：francesco.bandera@multimedica.it
-
Naples、イタリア
- まだ募集していません
- Irccs Synlab Sdn
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コンタクト：
- Carlo Cavaliere, MD
- メール：carlo.cavaliere@synlab.it
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Palermo、イタリア
- まだ募集していません
- Irccs Ismett
-
コンタクト：
- Manlio Cipriani, MD
- メール：mcipriani@ismett.edu
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Pavia、イタリア
- まだ募集していません
- IRCCS Istituti Clinici Scientifici Maugeri
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コンタクト：
- Maria Teresa La Rovere, MD
- メール：mariateresa.larovere@icsmaugeri.it
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Pavia、イタリア
- まだ募集していません
- IRCCS Fondazione Policlinico San Matteo
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コンタクト：
- Eloisa Arbustini, MD
- メール：e.arbustini@smatteo.pv.it
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Pozzilli、イタリア
- まだ募集していません
- IRCCS Neuromed
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コンタクト：
- Maria Benedetta Donati, MD
- メール：mariabenedetta.donati@neuromed.it
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Rome、イタリア
- まだ募集していません
- IRCCS Fondazione Policlinico Gemelli
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コンタクト：
- Giovanna Liuzzo, MD
- メール：giovanna.liuzzo@policlinicogemelli.it
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Rome、イタリア
- まだ募集していません
- IRCCS San Raffaele Roma
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コンタクト：
- Massimo Volpe, MD
- メール：massimo.volpe@sanraffaele.it
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San Donato Milanese、イタリア
- 募集
- IRCCS Policlinico San Donato
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コンタクト：
- Chiara Barberio, PhD
- 電話番号：02-52774838
- メール：cvriskit@grupposandonato.it
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コンタクト：
- Ambra Cerri, PhD
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主任研究者：
- Lorenzo Menicanti, MD
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副調査官：
- Emanuele Diangelantonio, MD
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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)
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：防止
- 割り当て：ランダム化
- 介入モデル：階乗代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
介入なし：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. |
|
|
実験的：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. |
|
実験的：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. |
|
実験的：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. |
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change in CVD risk using SCORE2/SCORE2-OP
時間枠：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
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change in cardiovascular modifiable risk factors
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
|
その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
CVD events recording in long-term period
時間枠：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
|
協力者と研究者
協力者
出版物と役立つリンク
一般刊行物
- 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.
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
キーワード
その他の研究ID番号
- CVRISK-IT
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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