Investigating blood vessel characteristics in children
Study of the Characteristics of the Vascular Wall in Pediatric Age
This study is testing how the health of blood vessels in children and teens can affect their heart health later in life, using a special device to measure how stiff their arteries are.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 500 (estimated) |
| Ages | 6 Years to 17 Years |
| Sex | All |
| Sponsor | IRCCS Azienda Ospedaliero-Universitaria di Bologna Academic / other |
| Locations | 1 site (Bologna) |
| Trial ID | NCT06774586 on ClinicalTrials.gov |
What this trial studies
This observational study aims to explore the characteristics of the vascular wall and assess cardiovascular risk in children and adolescents, regardless of existing heart disease. Participants will undergo a noninvasive diagnostic examination using an innovative device called VICORDER© to measure arterial stiffness, a key risk factor for cardiovascular disease. The study seeks to understand how early vascular changes can influence cardiovascular health later in life, particularly in relation to common pediatric risk factors such as obesity and hypertension.
Who should consider this trial
Good fit: Ideal candidates are children and adolescents aged 6 to 17 who are being treated in pediatric emergency departments.
Not a fit: Patients with behavioral disorders, severe cognitive impairments, or anatomical issues that prevent proper examination may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to early identification of cardiovascular risks in children, allowing for timely interventions.
How similar studies have performed: Other studies have recognized the importance of measuring arterial stiffness in pediatric populations, indicating a growing interest in this area, though this specific approach may be novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients from 6 to 17 years of age (extremes included) being treated in the Outpatient Departments of Emergency Pediatrics or admitted to the Department of Emergency Pediatrics * Patient cooperation during the performance of the examination. * Obtaining informed consent from the parent/legal guardian Exclusion Criteria: * Behavioral disorders or severe cognitive retardation, extreme agitation, or other factors that may impair the proper performance of the examination. * Anatomical alterations or presence of device or local pathology that conflicts with the placement of the VICORDER© cuffs.
Where this trial is running
Bologna
- IRCCS Azienda Ospedaliero - Universitaria di Bologna, U.O. Pediatria d'Urgenza, Pronto Soccorso e Osservazione Breve ed Intensiva — Bologna, Italy (Recruiting)
Study contacts
- Principal investigator: Marianna Fabi, MD — IRCCS Azienda Ospedaliero-Universitaria di Bologna
- Study coordinator: Marianna Fabi, MD
- Email: marianna.fabi@aosp.bo.it
- Phone: 0512143012
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.