CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 1,535 enrolled
Drug / intervention
Screening testother
Likely dose
Not stated in record
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Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05841719
NCT05841719N/ACompleted

General Population Universal Capillary Screening for Chronic Autoimmune, Metabolic and Cardiovascular Diseases (UNISCREEN): Feasibility and Acceptability Pilot Study.

Emanuele Bosi·interventional·Posted May 3, 2023·Updated Mar 6, 2024

In Brief

A clinical study evaluating Screening test for Cardiovascular Risk Factors and Autoimmune Diseases. Completed, enrolled 1,535 participants across 1 site.

Detailed Summary

This study represents a model for a public health program based on a general population screening for the most prevalent chronic metabolic, cardiovascular and autoimmune diseases across adulthood, childhood and adolescence. The main purpose is to assess feasibility and acceptability of using a capillary screening for this purpose. Secondly, it will be possibile to identify people at increased risk of developing one of these health conditions as well as those who are at pre-symptomatic clinical stages. Risk assessment is needed to identify prevention strategies; early diagnosis allows to start early treatment interventions aimed at reducing lifetime complications.This interventional study will enroll volunteers from Cantalupo, a locality belonging to the Municipality of Cerro Maggiore (Milan). Participants will be offered to undergo two capillary blood sampling to test blood glucose levels, glycated haemoglobin, total cholesterol, HDL-c, LDL-c, triglycerides and specific antibodies for type 1 diabetes and celiac disease. In case a participant screens positive for type I diabetes and/or celiac disease, they will be subsequently invited to undergo a new confirmatory blood draw on venous blood. Blood pressure will be also measured for each participant

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesItaly

Timeline

N/ACompletedFinished
202420252026
First PostedMay 3, 2023
Enrollment StartApr 22, 2023
Primary CompletionDec 31, 2023
Study CompletionJan 1, 2024
TodayJul 2, 2026
Enrollment to primary: 8 monthsPosted 3.2 years ago

Interventions

Screening testother

Capillary blood sampling by finger-prick devices and second confirmatory venous sampling when needed.