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

Malignant Solid Neoplasm Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05138991
• Other study ID #: 21466
• Secondary ID: NCI-2021-1133521
• Status: Recruiting
• Phase: N/A
• Start date: June 22, 2022
• Est. completion date: November 15, 2024

Study information

• Verified date: August 2023
• Source: City of Hope Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: November 15, 2024
• Est. primary completion date: November 15, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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).

Related Conditions & MeSH terms

• Hematopoietic and Lymphoid Cell Neoplasm
• Malignant Solid Neoplasm
• Neoplasms

Intervention

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

Locations

Country	Name	City	State
United States	City of Hope Medical Center	Duarte	California

Sponsors (2)

Lead Sponsor	Collaborator
City of Hope Medical Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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