NCT05892588

Brief Summary

This registry is a large-scale epidemiological study (PREVASC) aimed at estimating the prevalence of symptomatic and asymptomatic valvular hear disease in men and women aged over 65 years randomly selected in Italy.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2022

Geographic Reach
1 country

1 active site

Status
unknown

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

Study Start

First participant enrolled

June 1, 2022

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 7, 2023

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

May 25, 2023

Completed
13 days until next milestone

First Posted

Study publicly available on registry

June 7, 2023

Completed
24 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2023

Completed
Last Updated

June 7, 2023

Status Verified

June 1, 2023

Enrollment Period

11 months

First QC Date

May 25, 2023

Last Update Submit

June 5, 2023

Conditions

Valvular Heart DiseaseMitral Valve DiseaseAortic Valve StenosisAortic Valve InsufficiencyTricuspid Regurgitation

Outcome Measures

Primary Outcomes (1)

  • VALVOLAR HEART DISEASE PREVALENCE

    The aim is to estimate the prevalence of symptomatic and asymptomatic valvolar heart disease in men and women aged over 65 years randomly selected in Italy: a complete colour-Doppler echocardiography will be performed in peripheral centres using commercially available machines according to a pre-defined protocol. Echocardiograms will be recorded with standard DICOM format on digital

    at baseline

Secondary Outcomes (2)

  • LEFT VENTRICOLAR DIMENSIONS AND FUNCTION

    at baseline

  • BURDEN OF ATRIAL FIBRILLATION

    baseline

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Subject with \> 65 years with no history of previous valvular heart disease living in villages with less than 3000 inhabitants.

You may qualify if:

  • All subject ≥ 65 years with no history of previous valvular heart disease

You may not qualify if:

  • Age \<65 years
  • Any acute disease
  • Recent hospitalization (until 1 month).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

AOUCareggi

Florence, 50134, Italy

RECRUITING

MeSH Terms

Conditions

Heart Valve DiseasesAortic Valve StenosisAortic Valve InsufficiencyTricuspid Valve Insufficiency

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesAortic Valve DiseaseVentricular Outflow Obstruction

Central Study Contacts

Nazario NC Carrabba, phisician

CONTACT

00393355939482carrabban@aou-careggi.toscana.it

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 25, 2023

First Posted

June 7, 2023

Study Start

June 1, 2022

Primary Completion

May 7, 2023

Study Completion

July 1, 2023

Last Updated

June 7, 2023

Record last verified: 2023-06

Locations

IT(1)