Viewing Study NCT02863666


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Study NCT ID: NCT02863666
Status: COMPLETED
Last Update Posted: 2024-05-13
First Post: 2016-08-08
Is Gene Therapy: True
Has Adverse Events: True

Brief Title: Verification of Prediction Algorithm
Sponsor: Zoll Medical Corporation
Organization:

Study Overview

Official Title: Verification of a Prediction Algorithm for Cardiopulmonary Patients Admitted to the Emergency Department (ED) (VPAC)
Status: COMPLETED
Status Verified Date: 2023-12
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: VPAC
Brief Summary: Prospective observational clinical study to verify an algorithm used to predict cardiopulmonary events in patients presenting to the emergency department.
Detailed Description: A novel algorithm for determining risk of acute cardiac complications, including cardiac arrest, for patients presenting to the ED has recently been reported. Unlike prior risk stratification tools that relied on basic vital sign data, this algorithm utilizes advanced computing of ECG data to solve the risk classification problem. Data will be collected on patients presenting to the emergency department with a primary complaint that is determined to be cardiopulmonary of origin by a clinician.

Verification of the results of the previous studies using this algorithm in a more diverse patient cohorts is required. As such, the proposed study will investigate the accuracy of the algorithm.

Study Oversight

Has Oversight DMC: False
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: