Verification of Prediction Algorithm | Clinical Trial

Key information

Conditions

Shortness of Breath Episode Arrhythmias, Cardiac Bradycardia Cardiac Conduction System Disease Cardiovascular Diseases Difficulty Breathing Dyspnea Heart Arrest Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Tract Diseases Signs and Symptoms Signs and Symptoms, Respiratory Tachycardia

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Antwerp University Hospital, Antwerp, Belgium

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

Number of Subjects With a Cardiopulmonary Event

Time frame: Within 72 hours of presentation to ED

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)

Secondary outcomes

Cumulative Number of Cardiopulmonary Events in a Single Subject

Time frame: Within 72 hours of presentation to ED

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)

Sponsors and collaborators

Lead sponsor

Zoll Medical Corporation

Industry

Registry information

Official study title

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

Acronym: VPAC

Important dates

Study start: 2016
Primary completion: 2017
Study completion: 2017
First posted: Aug 11, 2016
Registry last updated: May 13, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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