RecruitingNot ApplicableNCT06362538

The Cardiovascular Prevention Program

Cardiovascular Prevention Program at Maria Cecilia Hospital


Sponsor

Maria Cecilia Hospital

Enrollment

150 participants

Start Date

May 13, 2024

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 YearsMax Age: 30 Years

Inclusion Criteria2

  • 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 Criteria5

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

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Interventions

OTHERInternational Physical Activity Questionnaire

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

OTHERSix 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.

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


Locations(1)

MCH

Cotignola, Ravenna, Italy

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NCT06362538


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