The Cardiovascular Prevention Program

Not Applicable

Recruiting

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

• Registration Number: NCT06362538
• Lead Sponsor: Maria Cecilia Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-03
• Study First Submitted: 2024-03-20
• Study First Submitted QC: 2024-04-08
• Study First Posted: 2024-04-12
• Study Start: 2024-05-13
• Last Update Submitted: 2024-08-27
• Last Update Posted: 2024-08-28
• Primary Completion: 2027-04-15
• Study Completion: 2027-04-15

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 150

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
subject with a negative or positive history of cardiovascular disease	Stool Sample Culture Test	no drugs or devices are included.
subject with a negative or positive history of cardiovascular disease	SF-36, Euro-Qol 5D-5L, Perceived stress scale-10, Pittsburgh Sleep Quality Index, Depression Anxiety Stress scale- 21.	no drugs or devices are included.
subject with a negative or positive history of cardiovascular disease	Intima-media thickness (IMT)	no drugs or devices are included.
subject with a negative or positive history of cardiovascular disease	Blood sampling	no drugs or devices are included.
subject with a negative or positive history of cardiovascular disease	International Physical Activity Questionnaire	no drugs or devices are included.
subject with a negative or positive history of cardiovascular disease	Six minute walking test	no drugs or devices are included.
subject with a negative or positive history of cardiovascular disease	MEDAS	no drugs or devices are included.

Primary Outcome Measures

Name	Time	Method
Adherence to the Mediterranean diet	12 months	Mediterranean Diet Adherence
blood glucose test	12 months	evaluation of blood glucose
blood pressure measurement	12 months	Evaluation of Diastolic Blood Pressure
measure of body mass index	12 months	BMI Assessment
blood test to check cholesterol levels	12 months	Assessment of hypercholesterolemia

Trial Locations

Locations (1)

MCH; 🇮🇹 Cotignola, Ravenna, Italy