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The Cardiovascular Prevention Program

Cardiovascular Prevention Program at Maria Cecilia Hospital

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06362538
Enrollment
150
Registered
2024-04-12
Start date
2024-05-13
Completion date
2027-04-15
Last updated
2024-08-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiovascular Prevention

Brief summary

Cardiovascular diseases represent one of the main public health problems being the leading cause of morbidity, disability and mortality. In recent decades, the global prevalence and cardiovascular disease mortality has increased, with 23.6 million annual deaths expected by 2030. In Europe, mortality per year is equal to 2.2 million women and 1.9 million men, representing 47% and 37% of all deaths respectively. In Italy, the situation in terms of deaths due to cardiovascular diseases it is in line with the world ranking and European, being responsible for 44% of all deaths. The only interventional or pharmacological approach is neither effective nor sustainable. The most deaths from cardiovascular diseases are due to atherothrombotic events, which are attributable to a series of risk factors, most of which are modifiable. Turns out itself as a targeted action on these factors with the aim of safeguarding the state of health cardiovascular, may represent the best applicable strategy. It is therefore necessary structure and activate prevention programs aimed at the general population and groups of subjects at higher risk.

Interventions

Assessments of physical activity level and functional capabilities (aerobic capacity, muscular strength and power, flexibility

The 6 Minute Walk Test is a sub-maximal exercise test used to assess aerobic capacity and endurance. The distance covered over a time of 6 minutes is used as the outcome by which to compare changes in performance capacity.

OTHERSF-36, Euro-Qol 5D-5L, Perceived stress scale-10, Pittsburgh Sleep Quality Index, Depression Anxiety Stress scale- 21.

Evaluation of the quality of life, the psychological sphere (anxiety, stress, depression) and the quality of sleep

OTHERMEDAS

Evaluation of adherence to the Mediterranean diet

OTHERIntima-media thickness (IMT)

Bmode ultrasonography

BIOLOGICALBlood sampling

Measurement of parameters for defining cardiovascular risk and biomarkers.

BIOLOGICALStool Sample Culture Test

Evaluation of Gut Microbiota

Sponsors

Maria Cecilia Hospital
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 30 Years
Healthy volunteers
No

Inclusion criteria

* primary prevention: age ≥ 30 years with a negative history of cardiovascular events * secondary prevention: age ≥ 30 years with a negative history of cardiovascular events

Exclusion criteria

* severe obesity * high-grade renal failure * severe and/or dialysis * oncological disease in active phase * pregnancy

Design outcomes

Primary

MeasureTime frameDescription
measure of body mass index12 monthsBMI Assessment
Adherence to the Mediterranean diet12 monthsMediterranean Diet Adherence
blood test to check cholesterol levels12 monthsAssessment of hypercholesterolemia
blood pressure measurement12 monthsEvaluation of Diastolic Blood Pressure
blood glucose test12 monthsevaluation of blood glucose

Countries

Italy

Contacts

Primary ContactElena Tenti
etenti@gvmnet.it0545217031

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026