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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Hematopoietic and Lymphoid Cell Neoplasm, Malignant Solid Neoplasm

Intervention / Treatment
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* Procedure: Echocardiogram Recording
* Other: Questionnaire Administration
* Procedure: Stress Cardiac Magnetic Resonance Imaging
* Device: Wireless Synchronized Cardiac Function Monitoring Device


Participation Criteria
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Eligibility Criteria
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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).
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Screening (echo, CMR, Tonometry-based system)<br>Patients undergo a one time assessment of cardiac function by echo, CMR, and the Tonometry-based system system in the clinic over 4-6 hours, and will be asked to perform their home-based measurements within 1-5 days of the clinical assessment, allowing us to directly compare measurements obtained by survivors to those by research personnel. Patients also complete questionnaires at baseline. | Procedure: Echocardiogram Recording<br>* Undergo assessment via echo<br>* Other names: Echocardiogram;Other: Questionnaire Administration<br>* Ancillary Studies<br>Procedure: Stress Cardiac Magnetic Resonance Imaging<br>* Undergo assessment via CMR<br>Device: Wireless Synchronized Cardiac Function Monitoring Device<br>* SphygmoCor® Xcel Oscar 2™ Ambulatory Blood Pressure Monitor<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Up to 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | Up to 2 years |