The Cardiovascular Prevention Program

Maria Cecilia Hospital

Status: Enrolling

Conditions: Cardiovascular Prevention

Treatments: Biological: Blood sampling; Other: Intima-media thickness (IMT); Other: International Physical Activity Questionnaire; Other: SF-36, Euro-Qol 5D-5L, Perceived stress scale-10, Pittsburgh Sleep Quality Index, Depression Anxiety Stress scale- 21.; Biological: Stool Sample Culture Test; Other: Six minute walking test; Other: MEDAS

Study type: Interventional

Funder types: Other

Identifiers

NCT06362538

MCH-ProCardioPrev

Details and patient eligibility

About

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.

Enrollment: 150 estimated patients

Sex: All

Ages: 18 to 30 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Sequential Assignment

Masking: None (Open label)

---

150 participants in 1 patient group

subject with a negative or positive history of cardiovascular disease

Other group

Description:

no drugs or devices are included.

Treatment:

Other: MEDAS

Other: Six minute walking test

Biological: Stool Sample Culture Test

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

Other: International Physical Activity Questionnaire

Other: Intima-media thickness (IMT)

Biological: Blood sampling