Verification of Prediction Algorithm

Bradycardia Clinical Trial

— VPAC  

Official title:

Verification of a Prediction Algorithm for Cardiopulmonary Patients Admitted to the Emergency Department (ED) (VPAC)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02863666
• Other study ID #: 5703
• Status: Completed
• Start date: August 11, 2016
• Est. completion date: December 15, 2017

Study information

• Verified date: December 2023
• Source: Zoll Medical Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Prospective observational clinical study to verify an algorithm used to predict cardiopulmonary events in patients presenting to the emergency department.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 673
• Est. completion date: December 15, 2017
• Est. primary completion date: December 13, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

18 years of age or older Admission to emergency department requiring immediate medical attention due to presumed cardiac or pulmonary cause(s) and considered 2nd or 3rd tier priority in triage system. Exclusion Criteria: Pregnant or suspected pregnancy Significant trauma Do Not Resuscitate order Known as Ward of the State

Related Conditions & MeSH terms

• Bradycardia
• Difficulty Breathing
• Dyspnea
• Shortness of Breath Episode
• Tachycardia

Locations

Country	Name	City	State
Belgium	Antwerp University Hospital	Antwerp
United States	University of Alabama	Birmingham	Alabama
United States	William Beaumont Hospital	Royal Oak	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
Zoll Medical Corporation

Countries where clinical trial is conducted

United States,  Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Subjects With a Cardiopulmonary Event	The number of any cardiopulmonary event, not limited to: Cardiac arrest Sustained ventricular tachycardia (VT) Hypotension requiring inotropes or intra-aortic balloon pump (IABP) insertion Intubation or mechanical ventilation Complete heart block Bradycardia requiring insertion of a pacing wire or external pacing, and Percutaneous coronary intervention (PCI) or coronary artery bypass surgery (CABG)	Within 72 hours of presentation to ED
Secondary	Cumulative Number of Cardiopulmonary Events in a Single Subject	The cumulative number of any cardiac and cardiac-related events, not limited to: In-hospital Death In-hospital Cardiac Arrest Composite cardiovascular outcome or intervention (Lethal Arrhythmias , Acute Pulmonary Edema, Cardiogenic Shock, Myocardial Infarction, Percutaneous Coronary Intervention, Coronary artery Bypass Surgery , New or Recurrent MI, Recurrent Ischemia requiring Revascularization)	Within 72 hours of presentation to ED