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Clinical Trials in Italy / NCT06362538
Recruiting Not applicable

The Cardiovascular Prevention Program

NCT06362538 · tracked via the Priya Life Science Italy tracker
Phase
Not applicable
Started
2024-05-13
Last updated
2024-08-28

Condition(s) studied

Cardiovascular Prevention

Investigational drug(s) / intervention(s)

International Physical Activity QuestionnaireSix minute walking testSF-36, Euro-Qol 5D-5L, Perceived stress scale-10, Pittsburgh Sleep Quality Index, Depression Anxiety Stress scale- 21.MEDASIntima-media thickness (IMT)Blood sampling →Stool Sample Culture Test

International Physical Activity Questionnaire: Assessments of physical activity level and functional capabilities (aerobic capacity, muscular strength and power, flexibility

Six minute walking test: 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.

SF-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

MEDAS: Evaluation of adherence to the Mediterranean diet

Intima-media thickness (IMT): Bmode ultrasonography

Blood sampling: Measurement of parameters for defining cardiovascular risk and biomarkers.

Stool Sample Culture Test: Evaluation of Gut Microbiota

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
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

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
MCH Cotignola Ravenna Recruiting

More Maria Cecilia Hospital trials in Italy

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06362538 on ClinicalTrials.gov ↗ ← All trials in Italy