Hematopoietic and Lymphoid Cell Neoplasm, Malignant Solid Neoplasm
Conditions
Brief 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.
Interventions
PROCEDUREEchocardiogram Recording
Undergo assessment via echo
OTHERQuestionnaire Administration
Ancillary Studies
PROCEDUREStress Cardiac Magnetic Resonance Imaging
Undergo assessment via CMR
DEVICEWireless Synchronized Cardiac Function Monitoring Device
SphygmoCor® Xcel Oscar 2™ Ambulatory Blood Pressure Monitor
Sponsors
National Cancer Institute (NCI)
City of Hope Medical Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SCREENING
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Accuracy of ejection fraction (EF) in the clinic setting, and determine its reproducibility at home. | Up to 2 years | 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
| Measure | Time frame | Description |
|---|---|---|
| Cost-effectiveness of tonometry-based screening in the clinic setting and at home. | Up to 2 years | 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). |
Countries
United States
Outcome results
None listed