Cardiovascular DiseasesPEDVASCNCT06774586
Study of the Characteristics of the Vascular Wall in Pediatric Age
An observational study of Cardiovascular Diseases, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 1 site in Italy.
Trial 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©. Read more about this study
- Who is it for?
- Ages 6 to 17 years
- Conditions the study is for
- Cardiovascular Diseases
- How many people
- 500 participants
- Where
- 1 siteItaly
- Study dates
- 18 Jun 2024to 31 Dec 2030
- 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 6 to 17 years
- All sexes
- No healthy volunteers
- Child
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).
Who may be able to join
- 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
Who cannot join
- 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.
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 d'Urgenza, Pronto Soccorso e Osservazione Breve ed Intensiva
Bologna, 40133
Marianna Fabi, MD, 0512143012, marianna.fabi@aosp.bo.it
Marianna Fabi, MD
About this study
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©.
Read the detailed description
Cardiovascular (CV) disease remains the leading cause of death in adulthood in industrialized countries, and processes of vascular wall disruption are a key pathogenetic element of this. These processes can begin as early as childhood, contributing to CV risk in later ages.
In particular, increased arterial stiffness is an independent CV risk factor that is associated with increased mortality, and its measurement may influence therapeutic decisions. The clinical value of studying arterial stiffness is recognized by the European Network for Noninvasive Investigation of Large Arteries and the 2018 European Society of Cardiology guidelines on hypertension.
The method considered as the gold standard for measuring arterial stiffness is carotid-femoral Pulse Wave Velocity (PWV), which can be measured noninvasively. The stiffer the arterial wall, the more PWV increases; left ventricular afterload and systolic arterial pressure (SAP) increase, while diastolic arterial pressure (DAP) and coronary perfusion decrease. Increased afterload promotes left ventricular hypertrophy, with increased oxygen demands, and thus increased susceptibility to myocardial ischemia.In pediatric age, the most important CV risk factors include overweight and obesity, hypertension (which, between 0 and 18 years has a prevalence of 3-5%, alterations in glucose and lipid metabolism, diabetes mellitus, and kidney disease, especially chronic renal failure. These risk factors promote increased arterial stiffness and thus the risk of adverse events.Some typical pediatric vasculitides can also change the morpho-functional characteristics of the artery wall. For example, Kawasaki disease (KD) is a vasculitis of medium- and small-caliber vessels affecting the preschool child, whose most fearsome complication is coronary aneurysms, with the possibility of partial or total secondary obstruction. It can also be associated with myocardial infarction and ischemic heart disease, and, more generally, patients are exposed to increased CV morbidity. Alterations in the structure and function of the arterial wall are also observed in adults born preterm, in children with congenital heart disease, or undergoing chemo-radiotherapy treatment for neoplasia, and even subjects with systemic diseases, such as systemic lupus erythematosus. A picture of multisystem inflammation with major cardiovascular involvement, Multisystem Inflammatory Syndrome in Children (MIS-C), is a rare but potentially fatal complication of SARS-CoV-2 infection in children, in which endothelial damage plays a central pathogenetic role and its possible association with arterial stiffness has been postulated, but studies on it are few. Detecting increased arterial stiffness as early as in children and adolescents could have important clinical repercussions for the above.
On the one hand, it would make it possible to stratify patients according to CV risk, also with a view to personalized medicine. It could allow the identification of new associations between certain diseases or exposure to environmental factors and increased arterial stiffness. Finally, it would allow assessment of the effectiveness of therapies: treatment from the earliest stages of functional impairment could change the natural history of disease, and consequently CV morbidity and mortality at later ages. VICORDER© is a quick and easy-to-use oscillometric device for studying vascular function by measuring, among other parameters, PWV. Its use in noninvasive measurement of PWV has been studied and validated in both adults and children and adolescents. In particular, the validation study by Kracht et al. was conducted in 156 children between 6 and 18 years of age, with the finding of excellent intra- and inter-observer repeatability, ease of use and tolerability for patients, making it suitable for large-scale studies. The study by Thurn et al. was conducted on 1003 healthy patients between 6 and 18 years of age and established normal PWV values (by sex, age, and height) measured with VICORDER© in pediatric age.
The device takes the form of a series of cuffs, similar in every way to a traditional sphygmomanometer, connected to a computer for analysis. The test involves the serial inflation and deflation of these cuffs, using an automatic procedure similar to that of measuring blood pressure with a digital sphygmomanometer.
- Conditions
- Cardiovascular Diseases
- Keywords
- vascular wall, pediatrics
- Medical subject headings
- Cardiovascular Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2025
- Study start18 Jun 2024
- Primary completion31 Dec 2030 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular DiseasesStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marianna Fabi, MD, Principal investigator, IRCCS Azienda Ospedaliero-Universitaria di Bologna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06774586
- Sponsor's protocol ID
- PEDVASC
- Acronym
- PEDVASC
- Status last verified
- Oct 2024
- First submitted
- 1 Dec 2024
- Last updated
- 14 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Characteristics of the Vascular Wall in Pediatric Age
- ClinicalTrials.gov ID
- NCT06774586
- Acronym / sponsor ID
- PEDVASC / PEDVASC
- Conditions
- Cardiovascular Diseases
- Keywords
- vascular wall, pediatrics
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- IRCCS Azienda Ospedaliero-Universitaria di BolognaUniversity, hospital or other
- Study start
- 18 Jun 2024 (actual)
- Primary completion
- 31 Dec 2030 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 14 Jan 2025 (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.
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©.
Detailed description
Cardiovascular (CV) disease remains the leading cause of death in adulthood in industrialized countries, and processes of vascular wall disruption are a key pathogenetic element of this. These processes can begin as early as childhood, contributing to CV risk in later ages.
In particular, increased arterial stiffness is an independent CV risk factor that is associated with increased mortality, and its measurement may influence therapeutic decisions. The clinical value of studying arterial stiffness is recognized by the European Network for Noninvasive Investigation of Large Arteries and the 2018 European Society of Cardiology guidelines on hypertension.
The method considered as the gold standard for measuring arterial stiffness is carotid-femoral Pulse Wave Velocity (PWV), which can be measured noninvasively. The stiffer the arterial wall, the more PWV increases; left ventricular afterload and systolic arterial pressure (SAP) increase, while diastolic arterial pressure (DAP) and coronary perfusion decrease. Increased afterload promotes left ventricular hypertrophy, with increased oxygen demands, and thus increased susceptibility to myocardial ischemia.In pediatric age, the most important CV risk factors include overweight and obesity, hypertension (which, between 0 and 18 years has a prevalence of 3-5%, alterations in glucose and lipid metabolism, diabetes mellitus, and kidney disease, especially chronic renal failure. These risk factors promote increased arterial stiffness and thus the risk of adverse events.Some typical pediatric vasculitides can also change the morpho-functional characteristics of the artery wall. For example, Kawasaki disease (KD) is a vasculitis of medium- and small-caliber vessels affecting the preschool child, whose most fearsome complication is coronary aneurysms, with the possibility of partial or total secondary obstruction. It can also be associated with myocardial infarction and ischemic heart disease, and, more generally, patients are exposed to increased CV morbidity. Alterations in the structure and function of the arterial wall are also observed in adults born preterm, in children with congenital heart disease, or undergoing chemo-radiotherapy treatment for neoplasia, and even subjects with systemic diseases, such as systemic lupus erythematosus. A picture of multisystem inflammation with major cardiovascular involvement, Multisystem Inflammatory Syndrome in Children (MIS-C), is a rare but potentially fatal complication of SARS-CoV-2 infection in children, in which endothelial damage plays a central pathogenetic role and its possible association with arterial stiffness has been postulated, but studies on it are few. Detecting increased arterial stiffness as early as in children and adolescents could have important clinical repercussions for the above.
On the one hand, it would make it possible to stratify patients according to CV risk, also with a view to personalized medicine. It could allow the identification of new associations between certain diseases or exposure to environmental factors and increased arterial stiffness. Finally, it would allow assessment of the effectiveness of therapies: treatment from the earliest stages of functional impairment could change the natural history of disease, and consequently CV morbidity and mortality at later ages. VICORDER© is a quick and easy-to-use oscillometric device for studying vascular function by measuring, among other parameters, PWV. Its use in noninvasive measurement of PWV has been studied and validated in both adults and children and adolescents. In particular, the validation study by Kracht et al. was conducted in 156 children between 6 and 18 years of age, with the finding of excellent intra- and inter-observer repeatability, ease of use and tolerability for patients, making it suitable for large-scale studies. The study by Thurn et al. was conducted on 1003 healthy patients between 6 and 18 years of age and established normal PWV values (by sex, age, and height) measured with VICORDER© in pediatric age.
The device takes the form of a series of cuffs, similar in every way to a traditional sphygmomanometer, connected to a computer for analysis. The test involves the serial inflation and deflation of these cuffs, using an automatic procedure similar to that of measuring blood pressure with a digital sphygmomanometer.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 6 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- 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).
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- 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.
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
Check whether pediatric patients with CV risk factors have increased arterial stiffness compared with patients without risk factors.
Time frame: through study completion, an average of 1 year
Check whether pediatric patients with CV risk factors have increased arterial stiffness compared with patients without risk factors.
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 14 Jan 2025.
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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.
Marianna Fabi, MD principal investigator
IRCCS Azienda Ospedaliero-Universitaria di Bologna
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 Diseases, 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 3 inclusion and 2 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 14 Jan 2025. 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 (0512143012, 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?
Check whether pediatric patients with CV risk factors have increased arterial stiffness compared with patients without risk factors. (time frame: through study completion, an average of 1 year). 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 14 Jan 2025.