Assessment of Cardiac and Carotid Ultrasound Measurements... | NCT07666451

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

NCT07666451

Sponsor

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Status

Recruiting

Last Update Posted

Jun 24, 2026Actual

Enrollment

1,400Estimated

Phase

Not provided

Conditions

Cardiovascular Imaging
Echocardiography
Carotid Intima-Media Thickness

Interventions

Not provided

Countries

Italy

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2026

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 17, 2026Actual

Primary Completion Date

Dec 31, 2031Estimated

Completion Date

Dec 31, 2031Estimated

First Submitted Date

Jun 19, 2026

First Submission Date that Met QC Criteria

Jun 19, 2026

First Posted Date

Jun 24, 2026Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 19, 2026

Last Update Posted Date

Jun 24, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

1,400Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Healthy Pediatric Cohort		Healthy children aged 0-18 years undergoing echocardiographic and carotid ultrasound assessment.

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

0 Years

Maximum Age

18 Years

Standard Ages

ChildAdult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Marianna Fabi, MD	Contact	+390512143012		marianna.fabi@aosp.bo.it

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
IRCCS Azienda Ospedaliero - Universitaria di Bologna, U.O. Pediatria	Recruiting	Bologna	Bologna	40138	Italy