Cardiovascular ImagingNORMECONCT07666451
Assessment of Cardiac and Carotid Ultrasound Measurements in a Cohort of Healthy Children in Italy
An observational study of Cardiovascular Imaging and Echocardiography, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 0 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Imaging, Echocardiography, Carotid Intima-Media Thickness
- How many people
- 1,400 participants
- Where
- 1 siteItaly
- Study dates
- 17 Mar 2026to 31 Dec 2031
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Inadequate quality of echocardiographic examination Acute or chronic disease affecting the participant Genetic syndrome or genetic disease
Who may be able to join
- 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
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
IRCCS Azienda Ospedaliero - Universitaria di Bologna, U.O. Pediatria
Bologna, Bologna, 40138
Marianna Fabi, MD, 0512143012, marianna.fabi@aosp.bo.it
About this study
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.
- Keywords
- Carotid Intima-Media Thickness, Echocardiography, Cardiovascular Imaging
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Healthy Pediatric Cohort | Healthy children aged 0-18 years undergoing echocardiographic and carotid ultrasound assessment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2026
- Study start17 Mar 2026
- Primary completion31 Dec 2031 (estimated)
- Study completion31 Dec 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular ImagingStudies of the same condition, open and under way.
- More trials run by IRCCS Azienda Ospedaliero-Universitaria di BolognaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,400 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07666451
- Sponsor's protocol ID
- NORMECO
- Acronym
- NORMECO
- Status last verified
- Jun 2026
- First submitted
- 19 Jun 2026
- Last updated
- 24 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Cardiac and Carotid Ultrasound Measurements in a Cohort of Healthy Children in Italy
- ClinicalTrials.gov ID
- NCT07666451
- Acronym / sponsor ID
- NORMECO / NORMECO
- Keywords
- Carotid Intima-Media Thickness, Echocardiography, Cardiovascular Imaging
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,400 participants (estimated)
- Lead sponsor
- IRCCS Azienda Ospedaliero-Universitaria di BolognaUniversity, hospital or other
- Study start
- 17 Mar 2026 (actual)
- Primary completion
- 31 Dec 2031 (estimated)
- Study completion
- 31 Dec 2031 (estimated)
- First posted
- 24 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy Pediatric Cohort | – | –Healthy children aged 0-18 years undergoing echocardiographic and carotid ultrasound assessment. |
Who may qualify
- Ages
- 0 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Inadequate quality of echocardiographic examination Acute or chronic disease affecting the participant Genetic syndrome or genetic disease
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Distribution of echocardiographic and carotid ultrasound measurements
Time frame: Baseline
Distribution of cardiac chamber dimensions, cardiac function parameters, coronary artery dimensions, and carotid intima-media thickness values in healthy children living in Italy.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiovascular Imaging and Echocardiography, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marianna Fabi, MD (+390512143012, marianna.fabi@aosp.bo.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Distribution of echocardiographic and carotid ultrasound measurements (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2026.