Cardiovascular RiskCVRISK-ITNCT06832644
Novel Risk Prediction Approaches for the Primary Prevention of Cardiovascular Diseases in Italy: the CVRISK-IT Trial (CVRISK-IT)
A study testing Lifestyle Management in people with Cardiovascular Risk and Genetic Cardiovascular Risk, run by IRCCS Policlinico S. Donato at 17 sites in Italy.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 40 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Risk, Genetic Cardiovascular Risk
- What is being tested?
- Lifestyle Management
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30,000 participants
- Where
- 17 sitesItaly
- Study dates
- 22 Jan 2025to 1 Jan 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
17 sites in 1 country. Contact the study team or a site near you to ask about taking part.
17 sites in 1 country
Italy17 sites, 17 recruiting
- Recruiting
Irccs Inrca
Ancona
Roberto Antonicelli, MD, +390718003450, r.antonicelli@inrca.it
- Not yet recruiting
IRCCS San Martino
Genova
Pietro Ameri, MD, pietro.ameri@unige.it
- Recruiting
IRCCS Auxologico Italiano
Milan
Gianfranco Parati, MD, 02-61911.1, gianfranco.parati@unimib.it
- Recruiting
IRCCS Cardiologico Monzino
Milan
Damiano Baldassarre, MD, +39 02.58002369, damiano.baldassarre@cardiologicomonzino.it
- Not yet recruiting
IRCCS Fondazione Cà Granda- Policlinico Milano
Milan
Stefano Carugo, MD, stefano.carugo@policlinico.mi.it
- Not yet recruiting
IRCCS Istituto Clinico Humanitas
Milan
Giuseppe Ferrante, MD, giuseppe.ferrante@hunimed.eu
- Recruiting
IRCCS Mario Negri
Milan
Maria Carla Roncaglioni, MD, 0239014-501, cvrisk-it_fase1@marionegri.it
- Recruiting
IRCCS Multimedica
Milan
Francesco Bandera, MD, 02.242091, francesco.bandera@multimedica.it
- Recruiting
IRCCS Ospedale San Raffaele
Milan
Paolo Camici, MD, 02 2643 8190/8191, cvriskit@hsr.it
- Not yet recruiting
Irccs Synlab Sdn
Naples
Carlo Cavaliere, MD, carlo.cavaliere@synlab.it
- Not yet recruiting
Irccs Ismett
Palermo
Manlio Cipriani, MD, mcipriani@ismett.edu
- Not yet recruiting
IRCCS Fondazione Policlinico San Matteo
Pavia
Eloisa Arbustini, MD, e.arbustini@smatteo.pv.it
- Not yet recruiting
IRCCS Istituti Clinici Scientifici Maugeri
Pavia
Maria Teresa La Rovere, MD, mariateresa.larovere@icsmaugeri.it
- Not yet recruiting
IRCCS Neuromed
Pozzilli
Maria Benedetta Donati, MD, mariabenedetta.donati@neuromed.it
- Not yet recruiting
IRCCS Fondazione Policlinico Gemelli
Rome
Giovanna Liuzzo, MD, giovanna.liuzzo@policlinicogemelli.it
- Not yet recruiting
IRCCS San Raffaele Roma
Rome
Massimo Volpe, MD, massimo.volpe@sanraffaele.it
- Recruiting
IRCCS Policlinico San Donato
San Donato Milanese
Chiara Barberio, PhD, 02-52774838, cvriskit@grupposandonato.it
Ambra Cerri, PhD
About this study
Official title: Novel Risk Prediction Approaches for the Primary Prevention of Cardiovascular Diseases in Italy: the CVRISK-IT Trial
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.
Read the detailed description
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.
- Conditions
- Cardiovascular Risk, Genetic Cardiovascular Risk
- Being tested
- Lifestyle Management
- Keywords
- Primary Prevention, Cardiovascular Risk, SCORE2/2-OP
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lifestyle ManagementBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | 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. |
| Imaging | Experimental | 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) Receives: Behavioral: Lifestyle Management |
| Polygenic Risk Score (PRS) | Experimental | 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 Receives: Behavioral: Lifestyle Management |
| Imaging and Polygenic Risk Score (PRS) | Experimental | 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). Receives: Behavioral: Lifestyle Management |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in CVD risk using SCORE2/SCORE2-OP
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%.
Measured: 12 months
Secondary outcomes (5)
Change in cardiovascular modifiable risk factors
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)
Measured: 12 months
Change in cardiovascular modifiable risk factors
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)
Measured: 12 months
Change in cardiovascular modifiable risk factors
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)
Measured: 12 months
Change in CVD prevention-drugs prescription
Secondary short-term outcomes will include changes in CVD prevention-drugs prescription with respect to the baseline visit
Measured: 12 months
Evaluation of participant's adherence to ESC recommendations
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
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2025
- Study start22 Jan 2025
- Primary completion1 Jan 2028 (estimated)
- Study completion1 Jan 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular RiskStudies of the same condition, open and under way.
- More trials run by IRCCS Policlinico S. DonatoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 30,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IRCCS Policlinico S. Donato
- Sponsor type
- University, hospital or other
- Collaborators
- Centro Cardiologico Monzino, Fondazione IRCCS Policlinico San Matteo di Pavia, Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Istituti Clinici Scientifici Maugeri SpA, Istituto Di Ricerche Farmacologiche Mario Negri, IRCCS Multimedica, Istituto Neurologico Mediterraneo Neuromed S. R. L, IRCCS San Raffaele, IRCCS San Raffaele Roma, IRCCS SYNLAB SDN, Istituto Clinico Humanitas, Istituto Nazionale di Ricovero e Cura per Anziani, The Mediterranean Institute for Transplantation and Advanced Specialized Therapies, Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico, Ospedale Policlinico San Martino, Istituto Auxologico Italiano
- Responsible party
- Principal investigator, Lorenzo Menicanti, IRCCS Policlinico S. Donato
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06832644
- Sponsor's protocol ID
- CVRISK-IT
- Acronym
- CVRISK-IT
- Status last verified
- Nov 2026
- First submitted
- 4 Feb 2025
- Last updated
- 6 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 35016208Di 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.
PubMed 41778587
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Novel Risk Prediction Approaches for the Primary Prevention of Cardiovascular Diseases in Italy: the CVRISK-IT Trial
- ClinicalTrials.gov ID
- NCT06832644
- Acronym / sponsor ID
- CVRISK-IT / CVRISK-IT
- Conditions
- Cardiovascular Risk, Genetic Cardiovascular Risk
- Keywords
- Primary Prevention, Cardiovascular Risk, SCORE2/2-OP
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30,000 participants (estimated)
- Lead sponsor
- IRCCS Policlinico S. DonatoUniversity, hospital or other
- Collaborators
- Centro Cardiologico Monzino, Fondazione IRCCS Policlinico San Matteo di Pavia, Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Istituti Clinici Scientifici Maugeri SpA, Istituto Di Ricerche Farmacologiche Mario Negri, IRCCS Multimedica, Istituto Neurologico Mediterraneo Neuromed S. R. L, IRCCS San Raffaele, IRCCS San Raffaele Roma, IRCCS SYNLAB SDN, Istituto Clinico Humanitas, Istituto Nazionale di Ricovero e Cura per Anziani, The Mediterranean Institute for Transplantation and Advanced Specialized Therapies, Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico, Ospedale Policlinico San Martino, Istituto Auxologico Italiano
- Study start
- 22 Jan 2025 (actual)
- Primary completion
- 1 Jan 2028 (estimated)
- Study completion
- 1 Jan 2030 (estimated)
- First posted
- 18 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –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. |
| Imaging | Experimental | Behavioral: Lifestyle ManagementSubjects 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) |
| Polygenic Risk Score (PRS) | Experimental | Behavioral: Lifestyle ManagementSubjects 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 |
| Imaging and Polygenic Risk Score (PRS) | Experimental | Behavioral: Lifestyle ManagementSubjects 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). |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lifestyle ManagementAll 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. | Behavioural | Imaging, Imaging and Polygenic Risk Score (PRS), Polygenic Risk Score (PRS) |
Primary outcome
Change in CVD risk using SCORE2/SCORE2-OP
Time frame: 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%.
5 secondary outcomes
Change in cardiovascular modifiable risk factors
Time frame: 12 months
Change in cardiovascular modifiable risk factors
Time frame: 12 months
Change in cardiovascular modifiable risk factors
Time frame: 12 months
Change in CVD prevention-drugs prescription
Time frame: 12 months
Evaluation of participant's adherence to ESC recommendations
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2026.
- Background: PubMed 35016208Timmis 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.
- Derived from this study: PubMed 41778587Di 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
17 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lifestyle Management in people with Cardiovascular Risk and Genetic Cardiovascular Risk, run by IRCCS Policlinico S. Donato at 17 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in CVD risk using SCORE2/SCORE2-OP (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06832644, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2026.