Ignite Creation Date:
2024-05-06 @ 8:07 PM
Last Modification Date:
2024-10-26 @ 3:20 PM
Study NCT ID:
NCT06257628
Status:
RECRUITING
Last Update Posted:
2024-02-14
First Post:
2023-10-18
Brief Title:
MACE CDS Software Master Enrollment Protocol
Sponsor:
Beckman Coulter Inc
Organization:
Beckman Coulter Inc
Study Overview
Official Title:
MACE CDS Software Master Enrollment Protocol
Status:
RECRUITING
Status Verified Date:
2024-02
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:
This protocol will collect real world EHR data to support the product development life cycle activities associated with developing the Major Adverse Cardiac Events MACE Clinical Decision Support CDS software
The data will also be utilized in subsequent clinical validation to support an FDA application andor applications to other regulatory agencies as needed
The data will also be utilized in subsequent clinical validation to support an FDA application andor applications to other regulatory agencies as needed
Detailed Description:
The primary objective is to develop a machine learning tool which predicts risk of 30-day MACE major adverse cardiac event risk stratification among patients visiting ED with suspicion of ACS Acute Coronary Syndrome
The data will also be utilized in subsequent clinical validation In addition to retrospective Electronic Health Record EHR data Health Information Exchange HIE data and patient reported outcomes will be collected to capture 30-day MACE outcomes as applicable
The data will also be utilized in subsequent clinical validation In addition to retrospective Electronic Health Record EHR data Health Information Exchange HIE data and patient reported outcomes will be collected to capture 30-day MACE outcomes as applicable
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None