Shortness of Breath EpisodeVPACNCT02863666
Verification of Prediction Algorithm
An observational study of Shortness of Breath Episode and Tachycardia, run by Zoll Medical Corporation at 3 sites in 2 countries.
Trial summary
Prospective observational clinical study to verify an algorithm used to predict cardiopulmonary events in patients presenting to the emergency department. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Shortness of Breath Episode, Tachycardia, Bradycardia
- How many people
- 673 participants
- Where
- 3 sitesin 2 countries
- Study dates
- 11 Aug 2016to 15 Dec 2017
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects presenting to the emergency department with cardiopulmonary related complaints
Who may be able to join
- 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.
Who cannot join
- Pregnant or suspected pregnancy Significant trauma Do Not Resuscitate order Known as Ward of the State
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
United States2 sites
University of Alabama
Birmingham, Alabama, 35249-7013
William Beaumont Hospital
Royal Oak, Michigan, 48073
About this study
Official title: Verification of a Prediction Algorithm for Cardiopulmonary Patients Admitted to the Emergency Department (ED) (VPAC)
Prospective observational clinical study to verify an algorithm used to predict cardiopulmonary events in patients presenting to the emergency department.
Read the 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.
- Keywords
- Cariopulmonary, cardiac arrest
- Medical subject headings
- Tachycardia, Bradycardia, Dyspnea, Heart Arrest
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Within 72 hours of presentation to ED
Secondary outcomes (1)
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)
Measured: Within 72 hours of presentation to ED
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2016 (estimated)
- Study start11 Aug 2016
- Primary completion13 Dec 2017
- Study completion15 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Shortness of Breath EpisodeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 673 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zoll Medical Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Michael Kurz, MD, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02863666
- Sponsor's protocol ID
- 5703
- Acronym
- VPAC
- Status last verified
- Dec 2023
- First submitted
- 8 Aug 2016
- Last updated
- 13 May 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Verification of a Prediction Algorithm for Cardiopulmonary Patients Admitted to the Emergency Department (ED) (VPAC)
- ClinicalTrials.gov ID
- NCT02863666
- Acronym / sponsor ID
- VPAC / 5703
- Keywords
- Cariopulmonary, cardiac arrest
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 673 participants (actual)
- Lead sponsor
- Zoll Medical CorporationIndustry (pharma, biotech, devices)
- Study start
- 11 Aug 2016 (actual)
- Primary completion
- 13 Dec 2017 (actual)
- Study completion
- 15 Dec 2017 (actual)
- First posted
- 11 Aug 2016 (estimated)
- Results
- Posted 13 May 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects presenting to the emergency department with cardiopulmonary related complaints
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- Pregnant or suspected pregnancy Significant trauma Do Not Resuscitate order Known as Ward of the State
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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)
1 secondary outcome
Cumulative Number of Cardiopulmonary Events in a Single Subject
Time frame: Within 72 hours of presentation to ED
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Shortness of Breath Episode
Active, not recruitingObservational study
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Deep Venous Thrombosis, Pulmonary Embolism
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Kurz, MD principal investigator
University of Alabama at Birmingham
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Shortness of Breath Episode and Tachycardia, run by Zoll Medical Corporation at 3 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States, Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 May 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Subjects With a Cardiopulmonary Event (time frame: Within 72 hours of presentation to ED). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2024.