Active — Not RecruitingNot Applicable

Reproducibility and Accuracy of a Portable System for Early Detection of Cardiac Dysfunction in Childhood Cancer Survivors

United States149 participantsStarted 2022-06-22

Plain-language summary

The clinical trial compares the reproducibility and accuracy of cardiac tonometry-based portable systems that may detect early cardiac dysfunction (SphygmoCor® Xcel and Oscar 2™ ambulatory blood pressure monitor) at home and in the clinic to currently available screening tests for heart failure including echocardiogram (echo) and cardiovascular magnetic resonance (CMR). The SphygmoCor® Xcel and Oscar 2™ systems may help detect cardiac dysfunction earlier than other available screening tests because it can be self-administered outside of the clinic. This study aims to test the accuracy and practicality of these devices in the clinic setting and at home.

Who can participate

SexALL

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Inclusion Criteria: * Previously enrolled in IRB# 14154. * Able to understand and sign the study specific informed consent form (ICF). Exclusion Criteria: * Participants cannot be actively receiving cancer-directed therapy. * Standard exclusion criteria for CMR imaging will be incorporated, and these include: implanted pacemaker or defibrillator, insulin pump, cochlear implant, central nervous system aneurismal clips, implanted neural stimulator, ocular foreign body (metal), other implanted medical devices (e.g.: drug infusion ports).

What they're measuring

Accuracy of ejection fraction (EF) in the clinic setting, and determine its reproducibility at home.

Timeframe: Up to 2 years

Trial details

NCT IDNCT05138991

SponsorCity of Hope Medical Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-07-16

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