Ignite Creation Date:
2024-05-06 @ 4:55 PM
Last Modification Date:
2024-10-26 @ 2:19 PM
Study NCT ID:
NCT05138991
Status:
RECRUITING
Last Update Posted:
2023-08-04
First Post:
2021-11-22
Brief Title:
Reproducibility and Accuracy of a Portable System for Early Detection of Cardiac Dysfunction in Childhood Cancer Survivors
Sponsor:
City of Hope Medical Center
Organization:
City of Hope Medical Center
Study Overview
Official Title:
Assessment of the Reproducibility and Accuracy of a Portable System for Early Detection of Cardiac Dysfunction in Childhood Cancer Survivors
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 Objectives
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 Objectives
Determine the cost-effectiveness of tonometry-based screening in the clinic setting and 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
Secondary Objectives
Determine the cost-effectiveness of tonometry-based screening in the clinic setting and at home
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R21CA261797 | NIH | City of Hope Medical Center | httpsreporternihgovquickSearchR21CA261797 |
| NCI-2021-11335 | REGISTRY | None | None |
| 21466 | OTHER | None | None |
| P30CA033572 | NIH | None | None |