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NCT Number: NCT06362538

The Cardiovascular Prevention Program

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.

Recruiting

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Key information

Conditions

Cardiovascular Prevention

Age range

18 year–30 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

MCH

Cotignola, Ravenna, 48033, Italy

Location status: Recruiting

Location contact

Anna Maria Malagoni

CONTACT

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

International Physical Activity Questionnaire

Other

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

six minute walking test

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.

Other

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

MEDAS

Other

Evaluation of adherence to the Mediterranean diet

Intima-media thickness (IMT)

Other

Bmode ultrasonography

Blood sampling

Biological

Measurement of parameters for defining cardiovascular risk and biomarkers.

Stool Sample Culture Test

Biological

Evaluation of Gut Microbiota

Primary outcomes

  1. measure of body mass index

    Time frame: 12 months

    BMI Assessment

  2. Adherence to the Mediterranean diet

    Time frame: 12 months

    Mediterranean Diet Adherence

  3. blood test to check cholesterol levels

    Time frame: 12 months

    Assessment of hypercholesterolemia

  4. blood pressure measurement

    Time frame: 12 months

    Evaluation of Diastolic Blood Pressure

  5. blood glucose test

    Time frame: 12 months

    evaluation of blood glucose

Study contacts

Contact information is provided by the study sponsor or research team.

Elena Tenti

CONTACT

[email protected]

0545217031 ext. +39

Sponsors and collaborators

Lead sponsor

Maria Cecilia Hospital

Other

Registry information

Official study title

Cardiovascular Prevention Program at Maria Cecilia Hospital

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Apr 12, 2024
Registry last updated
Aug 28, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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