Study of the Characteristics of the Vascular Wall in Pediatric Age

NCT06774586 | Recruiting

• 1 other identifier: PEDVASC
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

Brief Summary

With this study, we want to investigate the characteristics of the blood vessel wall and study cardiovascular risk in children and adolescents, whether or not they have heart disease, by subjecting patient to a noninvasive diagnostic examination with an innovative medical device called VICORDER©.

Conditions

Cardiovascular Diseases

Keywords

vascular wall; pediatrics

Outcome Measures

Primary Outcomes (1)

• Check whether pediatric patients with CV risk factors have increased arterial stiffness compared with patients without risk factors.

  Check whether pediatric patients with CV risk factors have increased arterial stiffness compared with patients without risk factors.

  through study completion, an average of 1 year

Eligibility Criteria

• Age: 6 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Vascular properties, and in particular arterial stiffness, will be studied in control patients or patients with cardiovascular risk factors and comorbidities, aged 6 to 17 years (extremes included).

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• IRCCS Azienda Ospedaliero-Universitaria di Bologna: lead

Study Sites (1)

IRCCS Azienda Ospedaliero - Universitaria di Bologna, U.O. Pediatria d'Urgenza, Pronto Soccorso e Osservazione Breve ed Intensiva

Bologna, 40133, Italy

RECRUITING

MeSH Terms

Conditions

Cardiovascular Diseases

Study Officials

• Marianna Fabi, MD

  IRCCS Azienda Ospedaliero-Universitaria di Bologna

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marianna Fabi, MD

CONTACT

0512143012; marianna.fabi@aosp.bo.it

Study Design

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

Study Record Dates

• First Submitted: December 1, 2024
• First Posted: January 14, 2025
• Study Start: June 18, 2024
• Primary Completion (Estimated): December 31, 2030
• Study Completion (Estimated): December 31, 2030
• Last Updated: January 14, 2025

Record last verified: 2024-10

Locations

IT (1)