The Cardiovascular Prevention Program

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-05-13

Study Completion Date

2027-04-15

Brief Summary

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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.

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Detailed Description

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Conditions

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Cardiovascular Prevention

Study Design

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Allocation Method

NA

Intervention Model

SEQUENTIAL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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subject with a negative or positive history of cardiovascular disease

no drugs or devices are included.

Group Type OTHER

International Physical Activity Questionnaire

Intervention Type OTHER

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

Six minute walking test

Intervention Type OTHER

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.

Intervention Type OTHER

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

MEDAS

Intervention Type OTHER

Evaluation of adherence to the Mediterranean diet

Intima-media thickness (IMT)

Intervention Type OTHER

Bmode ultrasonography

Blood sampling

Intervention Type BIOLOGICAL

Measurement of parameters for defining cardiovascular risk and biomarkers.

Stool Sample Culture Test

Intervention Type BIOLOGICAL

Evaluation of Gut Microbiota

Interventions

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International Physical Activity Questionnaire

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

Intervention Type OTHER

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.

Intervention Type OTHER

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

Intervention Type OTHER

MEDAS

Evaluation of adherence to the Mediterranean diet

Intervention Type OTHER

Intima-media thickness (IMT)

Bmode ultrasonography

Intervention Type OTHER

Blood sampling

Measurement of parameters for defining cardiovascular risk and biomarkers.

Intervention Type BIOLOGICAL

Stool Sample Culture Test

Evaluation of Gut Microbiota

Intervention Type BIOLOGICAL

Eligibility Criteria

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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