City of Hope Medical Center
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.
Hematopoietic and Lymphoid Cell Neoplasm
Malignant Solid Neoplasm
Echocardiogram Recording
Questionnaire Administration
Stress Cardiac Magnetic Resonance Imaging
Wireless Synchronized Cardiac Function Monitoring Device
Not Applicable
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 |
| Estimated Enrollment : | 200 participants |
| Masking : | None (Open Label) |
| Primary Purpose : | Screening |
| Official Title : | Assessment of the Reproducibility and Accuracy of a Portable System for Early Detection of Cardiac Dysfunction in Childhood Cancer Survivors |
| Actual Study Start Date : | June 22, 2022 |
| Estimated Primary Completion Date : | November 15, 2024 |
| Estimated Study Completion Date : | November 15, 2024 |
| Arm | Intervention/treatment |
|---|---|
|
Experimental: Screening (echo, CMR, Tonometry-based system) 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 Other: Questionnaire Administration Procedure: Stress Cardiac Magnetic Resonance Imaging Device: Wireless Synchronized Cardiac Function Monitoring Device |
| Ages Eligible for Study: | |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Accepts Healthy Volunteers |
Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.
Recruiting
City of Hope Medical Center
Duarte, California, United States, 91010