The Cardiovascular Prevention Program

Cardiovascular Prevention Clinical Trial

Official title:

Cardiovascular Prevention Program at Maria Cecilia Hospital

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06362538
• Other study ID #: MCH-ProCardioPrev
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 15, 2024
• Est. completion date: April 15, 2027

Study information

• Verified date: March 2024
• Source: Maria Cecilia Hospital
• Contact: Elena Tenti
• Phone: 0545217031
• Email: etenti[@]gvmnet.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 150
• Est. completion date: April 15, 2027
• Est. primary completion date: April 15, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 30 Years

Eligibility

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

Related Conditions & MeSH terms

• Cardiovascular Prevention

Intervention

Other:
• International Physical Activity Questionnaire
Assessments of physical activity level and functional capabilities (aerobic capacity, muscular strength and power, flexibility
• 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.
• 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
• MEDAS
Evaluation of adherence to the Mediterranean diet
• Intima-media thickness (IMT)
Bmode ultrasonography

Biological:
• Blood sampling
Measurement of parameters for defining cardiovascular risk and biomarkers.
• Stool Sample Culture Test
Evaluation of Gut Microbiota

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Maria Cecilia Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	measure of body mass index	BMI Assessment	12 months
Primary	Adherence to the Mediterranean diet	Mediterranean Diet Adherence	12 months
Primary	blood test to check cholesterol levels	Assessment of hypercholesterolemia	12 months
Primary	blood pressure measurement	Evaluation of Diastolic Blood Pressure	12 months
Primary	blood glucose test	evaluation of blood glucose	12 months