PROGETTO CV-PREVITAL – Page Press

 STUDIO CV-PREVITAL

CARDIOVASCULAR RISK PROFILE EVOLUTION OVER 15 YEARS: COMPARISON BETWEEN CV-PREVITAL TRIAL AND MOLI-SANI STUDY PARTICIPANTS

 

Abstract: Fifteen years elapsed between two surveys of cardiovascular (CV) risk factors in the same Italian region. Modifiable CV risk profiles were compared among 2,199 individuals enrolled in the CV-PREVITAL trial (2022-2024) at IRCCS Neuromed with those of 16,656 participants from the Moli-sani Study (2005-2010), matched for age and absence of prior CV disease. The Moli-sani Risk Score is a validated algorithm incorporating nine common modifiable risk factors measured overall risk. Most individual risk factors were more favorable in CV-PREVITAL compared with Moli-sani participants, besides hypertension in men and glucose levels in women. Relative fat mass was similar in both cohorts. Men in CV-PREVITAL had a mean Moli-sani Risk Score 4.8 points lower than Moli-sani men; women showed a 4.5-point reduction. These findings suggest a meaningful decline in modifiable CV risk over a 15- year interval, potentially reflecting enhanced prevention awareness, improved therapeutic efficacy, and cumulative effects of long-term public health communication.

Methods:
Study populations
The Moli-sani Study is a population-based cohort enrolled  in 2005-2010 in the Molise region, Italy. Extensive information on the Moli-sani Study has been reported elsewhere. From the original 24,325 participants, we selected 16,656 individuals aged 45 years or older without prior CV disease for the derivation of the Moli-sani Risk Score. To enhance comparability with the CV-PREVITAL cohort recruited from the same region, we identified a subset of Moli-sani participants in the same age range and, as in CV-PREVITAL, without prior cardiovascular disease, yielding 7,872 men and 8,784 women for comparison.
The CV-PREVITAL Study is a multicenter, prospective, randomized controlled trial sponsored by the Italian Ministry of Health and designed to evaluate the effectiveness of mobile health intervention in primary CV prevention.
At the IRCCS Neuromed recruitment center in Pozzilli (Isernia) 2,268 individuals aged 45 years or older, apparently free of CV disease, were enrolled between October 2022 and February 2024. For the present analysis, we retained 2,199 participants with complete baseline data.
Risk factor assessment
Both studies measured the same core variables using standardized procedures. Smoking was assessed by questionnaire and expressed as number of cigarettes daily. Mediterranean diet adherence was evaluated using validated food frequency questionnaires adapted to the Italian context. Lipid fractions (LDL, HDL, triglycerides) and glucose were measured in fasting blood samples. Blood pressure was recorded using calibrated devices,
and mean arterial pressure was calculated. Relative fat mass was computed from height, waist circumference, and sex using a validated formula.
The primary outcome measure was the Moli-sani Risk Score, a validated weighted algorithm incorporating nine modifiable CV risk factors: smoking, Mediterranean diet adherence, LDL cholesterol, HDL cholesterol, triglycerides, mean arterial pressure, glucose, leisure-time physical activity, and relative fat mass. The score was standardized so that a one-point change in the score corresponds to the CV risk equivalent of one year of age at baseline.
Statistics
Baseline characteristics are presented separately by sex, with means and standard errors adjusted for age. Comparisons between Moli-sani and CV-PREVITAL Neuromed cohorts used age-adjusted analysis of covariance for continuous variables and logistic regression for categorical outcomes. All analyses were conducted using SAS.

Reference: Augusto Di Castelnuovo, Mariarosaria Persichillo on behalf of the Moli-sani Study Investigators and the CV-PREVITAL Study Group*

Research Unit of Epidemiology and Prevention, IRCCS Neuromed, Pozzilli (IS), Italy
*Investigators from the Moli-sani and CV-PREVITAL studies are listed in the Appendix.