Verification of Prediction Algorithm

NCT ID: NCT02863666

Last Updated: 2024-05-13

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

673 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-08-11

Study Completion Date

2017-12-15

Brief Summary

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

Detailed Description

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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.

Conditions

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Shortness of Breath Episode Tachycardia Bradycardia Difficulty Breathing

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Zoll Medical Corporation

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Michael Kurz, MD

Role: PRINCIPAL_INVESTIGATOR

University of Alabama at Birmingham

Locations

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University of Alabama

Birmingham, Alabama, United States

Site Status

William Beaumont Hospital

Royal Oak, Michigan, United States

Site Status

Antwerp University Hospital

Antwerp, , Belgium

Site Status

Countries

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United States Belgium

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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5703

Identifier Type: -

Identifier Source: org_study_id

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