Evidence map›Paper›PMID 37451717›Full record

ArticleBMJ open2023

Rationale and design of the CV-PREVITAL study: an Italian multiple cohort randomised controlled trial investigating innovative digital strategies in primary cardiovascular prevention.

Damiano Baldassarre, Licia Iacoviello, Roberta Baetta, Maria Carla Roncaglioni, Gianluigi Condorelli, Giuseppe Remuzzi, Gianfranco Gensini, Luigi Frati, Walter Ricciardi, Pier Giulio Conaldi and 56 more

Registry-linked trialOpen access · goldAbstract readClinical Trial Protocol
In one paragraph

Article in BMJ open, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05339841 (Digital Strategies in Primary Cardiovascular Prevention in the Italian Population), which is not on this map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
1.3field-weighted citation impact, top 18% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT05339841 naactive not recruitingnot on this map

Digital Strategies in Primary Cardiovascular Prevention in the Italian Population

TypeinterventionalSponsorCentro Cardiologico MonzinoRan2022 to 2029Enrolled27,520ConditionsHealthy PopulationArmsMobile health application
3 · Its place in the literature

Who cites it

4 citing papers in PubMed, 6 citations in OpenAlex.

  1. Article
  2. Validation of Risk Perception Cut-Offs in Italian Brief PRHDS (PRHDS-BI): Implications for Primary Cardiovascular Prevention.High blood pressure & cardiovascular prevention : the official journal of the Italian Society of Hypertension · 2026
    Observational
  3. Article
  4. Exploring Hypertension Patient Engagement Using mHealth. A Scoping Review.High blood pressure & cardiovascular prevention : the official journal of the Italian Society of Hypertension · 2024
    Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

66 authors at 20 institutions in 1 country.

Damiano BaldassarreCentro Cardiologico Monzino IRCCS, Milan, Italy damiano.baldassarre@cardiologicomonzino.it.ORCID 0000-0002-2766-8882
Licia IacovielloDepartment of Epidemiology and Prevention, IRCCS Istituto Neurologico Mediterraneo NEUROMED, Pozzilli, Italy.ORCID 0000-0003-0514-5885
Roberta BaettaCentro Cardiologico Monzino IRCCS, Milan, Italy.
Maria Carla RoncaglioniLaboratory of Cardiovascular Prevention, Istituto di Ricerche Farmacologiche Mario Negri IRCCS, Milan, Italy.
Gianluigi CondorelliDepartment of Cardiovascular Medicine, IRCCS-Humanitas Research Hospital, Rozzano, Italy.
Giuseppe RemuzziIstituto di Ricerche Farmacologiche Mario Negri IRCCS, Milan, Italy.ORCID 0000-0002-6194-3446
Gianfranco GensiniIRCCS Multimedica, Milan, Italy.
Luigi FratiIRCCS Istituto Neurologico Mediterraneo NEUROMED, Pozzilli, Italy.
Walter RicciardiIstituti Clinici Scientifici Maugeri IRCCS Pavia, Pavia, Italy.
Pier Giulio ConaldiIRCCS ISMETT (Mediterranean Institute for Transplantation and Advanced Specialized Therapies), Palermo, Italy.
Antonio UccelliIRCCS Ospedale Policlinico San Martino, Genoa, Italy.
Fabio BlandiniFondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy.
Silvano BosariFondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy.
Giovanni ScambiaUniversità Cattolica del Sacro Cuore - Campus di Roma, Rome, Italy.
Massimo FiniIRCCS San Raffaele, Rome, Italy.
Antonio Di MaltaCo.S. (Consorzio Sanità) Study Center, Italy, Soresina, Italy.
Mauro AmatoCentro Cardiologico Monzino IRCCS, Milan, Italy.
Fabrizio VegliaMaria Cecilia Hospital, GVM Care & Research, Cotignola, Ravenna, Italy.
Alice BonomiCentro Cardiologico Monzino IRCCS, Milan, Italy.
Catherine KlersyUnit of Clinical Epidemiology & Biostatistic, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy.
Francesca ColazzoCentro Cardiologico Monzino IRCCS, Milan, Italy.
Martino PengoIstituto Auxologico Italiano IRCCS, Milan, Italy.
Francesca GoriniIstituto Auxologico Italiano IRCCS, Milan, Italy.
Luciana AuteriIstituto Auxologico Italiano IRCCS, Milan, Italy.
Giuseppe FerranteDepartment of Cardiovascular Medicine, IRCCS-Humanitas Research Hospital, Rozzano, Italy.
Marta BavieraLaboratory of Cardiovascular Prevention, Istituto di Ricerche Farmacologiche Mario Negri IRCCS, Milan, Italy.
Giuseppe AmbrosioCardiology, University of Perugia School of Medicine, Perugia, Italy.ORCID 0000-0002-9677-980X
Alberico CatapanoIRCCS Multimedica, Milan, Italy.
Alessandro GialluisiDepartment of Epidemiology and Prevention, IRCCS Istituto Neurologico Mediterraneo NEUROMED, Pozzilli, Italy.
Alexis Elias MalavazosEndocrinology Unit, Clinical Nutrition and Cardiovascular Prevention Service, IRCCS Policlinico San Donato, San Donato Milanese, Italy.
Serenella CastelvecchioDepartment of Cardiac Surgery, IRCCS Policlinico San Donato, San Donato Milanese, Italy.
Massimiliano Marco Corsi-RomanelliUOC SMEL-1, IRCCS POLICLINICO SAN DONATO, San Donato Milanese, Italy.
Rosanna CardaniBioCor Biobank, UOC SMEL-1 of Clinical Pathology, IRCCS-Policlinico San Donato, San Donato Milanese, Italy.
Maria Teresa La RovereIstituti Clinici Scientifici Maugeri IRCCS Montescano, Montescano, Italy.
Valentina AgneseIRCCS ISMETT (Mediterranean Institute for Transplantation and Advanced Specialized Therapies), Palermo, Italy.
Bianca PaneIRCCS Ospedale Policlinico San Martino, Genoa, Italy.
Daniele PratiDepartment of Transfusion Medicine and Haematology, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy.
Laura SpinardiFondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy.
Giovanna LiuzzoUniversità Cattolica del Sacro Cuore - Campus di Roma, Rome, Italy.
Eloisa ArbustiniCentro Malattie Genetiche Cardiovascolari - Fondazione IRCCS Policlinico San Matteo, Pavia, Italy.
Maurizio VolterraniCardio Pulmonary Department, IRCCS San Raffaele, Rome, Italy.
Marco ViscontiCo.S. (Consorzio Sanità) Study Center, Italy, Soresina, Italy.
José Pablo WerbaCentro Cardiologico Monzino IRCCS, Milan, Italy.
Stefano GenoveseCentro Cardiologico Monzino IRCCS, Milan, Italy.
Grzegorz BiloIstituto Auxologico Italiano IRCCS, Milan, Italy.ORCID 0000-0002-5104-9176
Cecilia InvittiIstituto Auxologico Italiano IRCCS, Milan, Italy.
Anna Di BlasioIstituto Auxologico Italiano IRCCS, Milan, Italy.
Carolina LombardiIstituto Auxologico Italiano IRCCS, Milan, Italy.
Andrea FainiIstituto Auxologico Italiano IRCCS, Milan, Italy.
Debora RosaIstituto Auxologico Italiano IRCCS, Milan, Italy.
Luisa Ojeda-FernándezLaboratory of Cardiovascular Prevention, Istituto di Ricerche Farmacologiche Mario Negri IRCCS, Milan, Italy.
Andreana ForestaLaboratory of Cardiovascular Prevention, Istituto di Ricerche Farmacologiche Mario Negri IRCCS, Milan, Italy.
Amalia De CurtisDepartment of Epidemiology and Prevention, IRCCS Istituto Neurologico Mediterraneo NEUROMED, Pozzilli, Italy.
Augusto Di CastelnuovoMediterranea Cardiocentro, Naples, Italy.ORCID 0000-0001-9767-7998
Simonetta ScalviniIstituti Clinici Scientifici Maugeri IRCCS Lumezzane, Lumezzane, Italy.
Antonia PierobonIstituti Clinici Scientifici Maugeri IRCCS Montescano, Montescano, Italy.
Alessandra GoriniIstituti Clinici Scientifici Maugeri IRCCS Milano, Milan, Italy.
Luca ValentiDepartment of Transfusion Medicine and Haematology, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy.
Livio LuziIRCCS Multimedica, Milan, Italy.
Annarosa RaccaFederfarma Lombardia & Fondazione Guido Muralti, Milan, Italy.
Manuela BandiFederfarma Lombardia & Fondazione Guido Muralti, Milan, Italy.
Elena TremoliMaria Cecilia Hospital, GVM Care & Research, Cotignola, Ravenna, Italy.
Lorenzo MenicantiDepartment of Cardiac Surgery, IRCCS Policlinico San Donato, San Donato Milanese, Italy.
Gianfranco ParatiIstituto Auxologico Italiano IRCCS, Milan, Italy.
Giulio PompilioCentro Cardiologico Monzino IRCCS, Milan, Italy.
CV-PREVITAL Study Group
IRCCS Istituto Auxologico Italiano · ITUniversity of Milan · ITCentro Cardiologico Monzino · ITMario Negri Institute for Pharmacological Research · ITFondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico · ITIstituto Neurologico Mediterraneo · ITIRCCS Policlinico San Donato · ITIstituti Clinici Scientifici Maugeri · ITUniversità Cattolica del Sacro Cuore · ITConsorzio per la Ricerca Sanitaria · ITHumanitas University · ITIstituto Mediterraneo per i Trapianti e Terapie ad Alta Specializzazione · ITMaria Cecilia Hospital · ITOspedale Policlinico San Martino · ITPoliclinico San Matteo Fondazione · ITClinica Mediterranea · ITIRCCS Ospedale San Raffaele · ITMultiMedica · ITSan Raffaele University of Rome · ITUniversity of Perugia · IT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionPrevention of cardiovascular disease (CVD) is of key importance in reducing morbidity, disability and mortality worldwide. Observational studies suggest that digital health interventions can be an effective strategy to reduce cardiovascular (CV) risk. However, evidence from large randomised clinical trials is lacking. METHODS AND ANALYSIS: The CV-PREVITAL study is a multicentre, prospective, randomised, controlled, open-label interventional trial designed to compare the effectiveness of an educational and motivational mobile health (mHealth) intervention versus usual care in reducing CV risk. The intervention aims at improving diet, physical activity, sleep quality, psycho-behavioural aspects, as well as promoting smoking cessation and adherence to pharmacological treatment for CV risk factors. The trial aims to enrol approximately 80 000 subjects without overt CVDs referring to general practitioners' offices, community pharmacies or clinics of Scientific Institute for Research, Hospitalization and Health Care (Italian acronym IRCCS) affiliated with the Italian Cardiology Network. All participants are evaluated at baseline and after 12 months to assess the effectiveness of the intervention on short-term endpoints, namely improvement in CV risk score and reduction of major CV risk factors. Beyond the funded life of the study, a long-term (7 years) follow-up is also planned to assess the effectiveness of the intervention on the incidence of major adverse CV events. A series of ancillary studies designed to evaluate the effect of the mHealth intervention on additional risk biomarkers are also performed. ETHICS AND DISSEMINATION: This study received ethics approval from the ethics committee of the coordinating centre (Monzino Cardiology Center; R1256/20-CCM 1319) and from all other relevant IRBs and ethics committees. Findings are disseminated through scientific meetings and peer-reviewed journals and via social media. Partners are informed about the study's course and findings through regular meetings. TRIAL REGISTRATION NUMBER: NCT05339841.

Indexed as

Cardiovascular DiseasesDietExerciseHumansMulticenter Studies as TopicProspective StudiesRandomized Controlled Trials as TopicCardiac EpidemiologyClinical trialsHealth informaticsPREVENTIVE MEDICINE

Identifiers

PMID37451717
PMCPMC10351259
OpenAlexW4384344060

What OpenQuestion holds

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LicenceCC BY-NC
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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.