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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

150

participants targeted

Target at P75+ for not_applicable

Timeline

12mo left

Started May 2024

Typical duration for not_applicable

Geographic Reach

1 country

1 active site

Status

recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

2.9 years study duration

Study Progress68%

May 2024Apr 2027

First Submitted

Initial submission to the registry

March 20, 2024

Completed

23 days until next milestone

First Posted

Study publicly available on registry

April 12, 2024

Completed

1 month until next milestone

Study Start

First participant enrolled

May 13, 2024

Completed

2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 15, 2027

Expected

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 15, 2027

Last Updated

August 28, 2024

Status Verified

March 1, 2024

Enrollment Period

2.9 years

First QC Date

March 20, 2024

Last Update Submit

August 27, 2024

Conditions

Cardiovascular Prevention

Outcome Measures

Primary Outcomes (5)

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

Study Arms (1)

subject with a negative or positive history of cardiovascular disease

OTHER

no drugs or devices are included.

Other: International Physical Activity QuestionnaireOther: Six minute walking testOther: SF-36, Euro-Qol 5D-5L, Perceived stress scale-10, Pittsburgh Sleep Quality Index, Depression Anxiety Stress scale- 21.Other: MEDASOther: Intima-media thickness (IMT)Biological: Blood samplingBiological: Stool Sample Culture Test

Interventions

International Physical Activity QuestionnaireOTHER

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