Assessment of Cardiac and Carotid Ultrasound Measurements in a Cohort of Healthy Children in Italy

NCT07666451 | Recruiting DMC

• 1 other identifier: NORMECO
• Study Type: observational
• Target: 1,400
• Locations: 1 country
• Sites: 1

Brief Summary

This observational ambispective cohort study aims to establish reference values for cardiac structure and function, coronary artery dimensions, and carotid intima-media thickness (cIMT) in a healthy pediatric population living in Italy. Healthy children aged 0-18 years undergoing cardiologic evaluation will be enrolled. Echocardiographic and carotid ultrasound parameters will be collected together with anthropometric and demographic data. The study includes both retrospective and prospective cohorts.

Conditions

Cardiovascular Imaging; Echocardiography; Carotid Intima-Media Thickness

Keywords

Carotid Intima-Media Thickness; Echocardiography; Cardiovascular Imaging

Outcome Measures

Primary Outcomes (1)

• Distribution of echocardiographic and carotid ultrasound measurements

  Distribution of cardiac chamber dimensions, cardiac function parameters, coronary artery dimensions, and carotid intima-media thickness values in healthy children living in Italy.

  Baseline

Study Arms (1)

Healthy Pediatric Cohort

Healthy children aged 0-18 years undergoing echocardiographic and carotid ultrasound assessment.

Eligibility Criteria

• Age: 0 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Inadequate quality of echocardiographic examination Acute or chronic disease affecting the participant Genetic syndrome or genetic disease

You may qualify if:

• Age between 0 and 18 years (inclusive) Availability of demographic and anthropometric data Negative past and recent medical history for chronic or acute diseases Adequate quality of echocardiographic evaluation Written informed consent obtained from parent/legal guardian and assent from the minor when applicable

Sponsors & Collaborators

• IRCCS Azienda Ospedaliero-Universitaria di Bologna: lead

Study Sites (1)

IRCCS Azienda Ospedaliero - Universitaria di Bologna, U.O. Pediatria

Bologna, Bologna, 40138, Italy

RECRUITING

Central Study Contacts

Marianna Fabi, MD

CONTACT

+390512143012; marianna.fabi@aosp.bo.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 19, 2026
• First Posted: June 24, 2026
• Study Start: March 17, 2026
• Primary Completion (Estimated): December 31, 2031
• Study Completion (Estimated): December 31, 2031
• Last Updated: June 24, 2026

Record last verified: 2026-06

Locations

IT (1)