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Italian Digital Primary Cardiovascular Prevention Study

Study acronym: CV-PREVITAL
StatusActive, Not Recruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

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  1. Collaborators reorderedv6
  2. Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 82800 to confirmed 27520
    • Study description expanded, about 210 words
    • Site details revised at 32 of 32 sites
    v5
  3. Re-verified, no change to tracked fieldsv4
  4. Study description expanded, about 262 words
    • Site details revised at 2 of 32 sites
    v3
  5. Trial status: Not Yet Recruiting to Recruitingv2 Show 4 more changesShow less
    • Study sites: 33 to 32
    • Primary completion date: May 2029 to Jun 2029
    • Start date changed from estimate of May 2022 to Jun 10, 2022
    • Secondary endpoints: details revised at 3 of 34 entries
  6. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
The CV-PREVITAL study is a randomised clinical trial (RCT) controlled versus usual-care designed to compare the effectiveness of a mobile health (mHealth) intervention with that of usual care in reducing specific cardiovascular (CV) risk factors (in the short term) and the occurrence of vascular events (in the long term). Promoted by the Italian Network of Cardiology (ICN, a cardiovascular research network promoted by the Italian Ministry of Health), in collaboration with the Consorzio Sanità (Co.S., an Italian consortium of general practitioners), CV-PREVITAL aims to develop an innovative model of cardiovascular primary prevention and to validate it in a very large sample of subjects and in 'real life' conditions.
Trial Details
NCT Number NCT05339841
Lead Sponsor Centro Cardiologico Monzino
Collaborators: Istituto Auxologico Italiano, Humanitas Hospital, Italy, Istituto Di Ricerche Farmacologiche Mario Negri, IRCCS Multimedica, Neuromed IRCCS, IRCCS Policlinico S. Donato, Istituti Clinici Scientifici Maugeri SpA, The Mediterranean Institute for Transplantation and Advanced Specialized Therapies, Ospedale Policlinico San Martino, Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Fondazione IRCCS Policlinico San Matteo di Pavia, IRCCS San Raffaele Roma, Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Conditions
(from sponsor)		 Healthy Population
Related terms Diabetes Mellitus, Hypercholesterolemia, Hypertension
Enrollment 27,520 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov