NCT05138991

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

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

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 149 (actual)
• Sponsor: City of Hope Medical Center · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Accepted

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.

Detailed description

Primary Objective(s) Validate the accuracy of ejection fraction, as measured using a tonometry-based system (SphygmoCor® Xcel), in the clinic setting, and determine the reproducibility (Oscar 2™) at home. Secondary Objective(s) Determine the cost-effectiveness of tonometry-based screening in the clinic setting and at home.

Conditions

• Hematopoietic and Lymphoid Cell Neoplasm
• Malignant Solid Neoplasm

Interventions

Type	Name	Description
PROCEDURE	Echocardiogram Recording	Undergo assessment via echo
OTHER	Questionnaire Administration	Ancillary Studies
PROCEDURE	Stress Cardiac Magnetic Resonance Imaging	Undergo assessment via CMR
DEVICE	Wireless Synchronized Cardiac Function Monitoring Device	SphygmoCor® Xcel Oscar 2™ Ambulatory Blood Pressure Monitor

Timeline

• Start date: 2022-06-22
• Primary completion: 2026-07-16
• Completion: 2026-07-16
• First posted: 2021-12-01
• Last updated: 2025-09-23

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study