Health TrialsbyHealthPanel

The Cardiovascular Prevention Program

ConditionCardiovascular Prevention
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-30
SponsorMaria Cecilia Hospital

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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

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

Disqualifiers

severe obesity

high-grade renal failure

severe and/or dialysis

oncological disease in active phase

Trial design

Design model

Sequential

Treatments tested in this trial

  • International Physical Activity Questionnaire

    Other intervention

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

  • Six minute walking test

    Other intervention

    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.

    Other intervention

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

  • MEDAS

    Other intervention

    Evaluation of adherence to the Mediterranean diet

  • Intima-media thickness (IMT)

    Other intervention

    Bmode ultrasonography

  • Blood sampling

    Biological/Vaccine

    Measurement of parameters for defining cardiovascular risk and biomarkers.

  • Stool Sample Culture Test

    Biological/Vaccine

    Evaluation of Gut Microbiota

Treatment groups

150 Participants
are divided into 1 treatment group
Group A: subject with a negative or positive history of cardiovascular diseaseOther 7 interventions

Trial outcomes

Primary outcomes

1

measure of body mass index

BMI Assessment

Time frame
12 months
2

Adherence to the Mediterranean diet

Mediterranean Diet Adherence

Time frame
12 months
3

blood test to check cholesterol levels

Assessment of hypercholesterolemia

Time frame
12 months
4

blood pressure measurement

Evaluation of Diastolic Blood Pressure

Time frame
12 months

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Maria Cecilia Hospital

Lead sponsor

Source ClinicalTrials.gov
Apply now