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NCT05138991 | RECRUITING | Hematopoietic and Lymphoid Cell Neoplasm

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

City of Hope Medical Center

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.

Condition or disease

Hematopoietic and Lymphoid Cell Neoplasm

Malignant Solid Neoplasm

Intervention/treatment

Echocardiogram Recording

Questionnaire Administration

Stress Cardiac Magnetic Resonance Imaging

Wireless Synchronized Cardiac Function Monitoring Device

Phase

NA

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.

Study Type : INTERVENTIONAL
Estimated Enrollment : 200 participants
Masking : NONE
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 : 2022-06-22
Estimated Primary Completion Date : 2025-06-30
Estimated Study Completion Date : 2025-06-30

Information not available for Arms and Intervention/treatment

Ages Eligible for Study:
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: 1
Criteria
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).
Reproducibility and Accuracy of a Portable System for Early Detection of Cardiac Dysfunction in Childhood Cancer Survivors

Location Details

NCT05138991

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How to Participate

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Locations

RECRUITING

United States, California

City of Hope Medical Center

Duarte, California, United States, 91010