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

N/AActive Not RecruitingNCT05138991

City of Hope Medical Center149 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

SCREENING

Masking

NONE

Enrollment

149

Conditions

Hematopoietic and Lymphoid Cell Neoplasm Malignant Solid Neoplasm

Interventions

Echocardiogram RecordingPROCEDURE

Undergo assessment via echo

Questionnaire AdministrationOTHER

Ancillary Studies

Stress Cardiac Magnetic Resonance ImagingPROCEDURE

Undergo assessment via CMR

Wireless Synchronized Cardiac Function Monitoring DeviceDEVICE

SphygmoCor® Xcel Oscar 2™ Ambulatory Blood Pressure Monitor

Eligibility

Sex: ALLHealthy volunteers:

Medical Language ↔ Plain English

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).

Outcomes

Primary Outcomes

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

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.

Time frame: Up to 2 years

Secondary Outcomes

Cost-effectiveness of tonometry-based screening in the clinic setting and at home.

Will apply the sensitivity and specificity of echo, CMR, and the Oscar 2™ ABPM system (clinic, home-based) to compare the number of asymptomatic cardiac dysfunction cases identified via each method. Screening costs for echo and CMR, including costs of clinical services, will be obtained from the 2020 Centers for Medicare \& Medicaid Services (CMS).