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

City of Hope

Status: Active, not recruiting

Conditions: Hematopoietic and Lymphoid Cell Neoplasm; Malignant Solid Neoplasm

Treatments: Other: Questionnaire Administration; Procedure: Stress Cardiac Magnetic Resonance Imaging; Procedure: Echocardiogram Recording; Device: Wireless Synchronized Cardiac Function Monitoring Device

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05138991

R21CA261797 (U.S. NIH Grant/Contract)

21466 (Other Identifier)

P30CA033572 (U.S. NIH Grant/Contract)

NCI-2021-11335 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 149 patients

Sex: All

Volunteers: Accepts Healthy Volunteers

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).

Trial design

Primary purpose: Screening

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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149 participants in 1 patient group

Screening (echo, CMR, Tonometry-based system)

Experimental group

Description:

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.

Treatment:

Device: Wireless Synchronized Cardiac Function Monitoring Device

Procedure: Echocardiogram Recording

Procedure: Stress Cardiac Magnetic Resonance Imaging

Other: Questionnaire Administration