An interventional study of Parameters of vascular stiffness in Cardiotoxicity, sponsored by IRCCS Azienda Ospedaliero-Universitaria di Bologna. Recruiting at 5 sites in Italy. Open to participants aged 0 Years to 18 Years. Per ClinicalTrials.gov, last updated 2026-02-02.
Sponsored by IRCCS Azienda Ospedaliero-Universitaria di Bologna · Not applicable, Interventional, and Diagnostic
To test whether the implementation of new diagnostic techniques (ultrasonography, speckle tracking, vascular stiffness study, cardiac MRI, and histologic studies) allows in CAYA (Childern, Adolescents, and Young Adults) cancer survivors a more sensitive and earlier identification of cardiovascular damage resulting from antineoplastic therapy that develops either acutely or remotely after completion of antineoplastic therapy.
Cardiovascular system is among the main target organs of toxicity of some antineoplastic treatments. Pretreatment cardiotoxicity risk stratification and timing tailored to patient needs are strategies recognized in cardiology but not yet well validated in the pediatric population. Currently, follow-up of the pediatric patient diagnosed with oncologic disease involves serious cardiologic evaluation, independent of cardiovascular risk factors and focused on recognition of left ventricular systolic dysfunction. The use of new diagnostic methods to study the pediatric patient exposed to antineoplastic therapy and the personalization of follow-up on the basis of pretreatment cardiovascular risk could allow early identification of cardiotoxic damage and thus prevent its progression.
262 studies on the registry are indexed under Cardiotoxicity; 75 are open to participants now.
This study's planned enrollment of 400 is above the median of 93 across 137 interventional studies indexed under Cardiotoxicity.
Browse Cardiotoxicity studies →IRCCS Azienda Ospedaliero-Universitaria di Bologna is the lead sponsor of 511 studies on the registry; 287 are open to participants now.
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VICORDER© is a noninvasive, quick and painless technique to be able to assess vascular elasticity and consists of placing a few sphygmomanometers (the same ones used to measure blood pressure) for a few minutes
Incidence of cardiovascular events in CAYA cancer survivors during treatment and follow-up
Number of cardiovascular events, defined according to ESC 2022 guidelines (Eur Heart J. 2022;43:4229-4361), detected during treatment and follow-up. Time to occurrence of events will be measured relative to pre-treatment evaluation.
Time frame: From initiation of antineoplastic therapy up to 12 months post-therapy
Started Mar 2025 (actual). Primary completion is estimated for Dec 2028, 45 months after the start.
Of 48 non-industry interventional studies with no phase under Cardiotoxicity, half reached primary completion within 52 months of starting (the median), counting those still running; a quarter within 35 and three quarters within 73. This study's planned 45 months is below that.
Counting every sponsor, half of 48 studies reached it within 52 months; a quarter within 35 and three quarters within 73.
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