ClinicalTrials.gg
CompletedNCT03390270Updated Sep 30, 2019

Risk-score Based ICU Triage

An observational study in Non-ST Elevation Myocardial Infarction (nSTEMI), sponsored by Duke University. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-09-30.

Sponsored by Duke University · Observational

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Study type
Observational
Model
Cohort
Time perspective
Other
Enrollment
462
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-13

Among 45 studies in Non-ST Elevated Myocardial Infarction with a site in United States — 3 open to participants now, 10 under way, none of them phase 3. Non-ST Elevated Myocardial Infarction · United States.

Enrollment
8th of 18
462 · median 406
Started
2018
with 3 others
Observational
18 of 45
2 open now
Registered
20th of 45
by date

Among the 45 studies in Non-ST Elevated Myocardial Infarction with a site in United States, this one is the 8th largest by enrollment of the 18 observational ones that give a count, is one of 4 that started in 2018, is one of 18 observational ones, and was the 20th registered.

Non-ST Elevated Myocardial Infarction

284 studies on the registry are indexed under Non-ST Elevated Myocardial Infarction; 52 are open to participants now.

Browse Non-ST Elevated Myocardial Infarction studies →

Open to participants now

3 of the 45 studies in Non-ST Elevated Myocardial Infarction with a site in United States are open now. Recruiting first, the newest first:

All 3 open studies →

A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →

Who these studies take

Of the 40 Non-ST Elevated Myocardial Infarction studies recruiting now, 34 (85%) set no upper age limit and 1 (3%) stops at 75 or younger; 4 take children under 18; 2 take healthy volunteers.

This study: 18 Years and older · all sexes · no healthy volunteers.

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02

Study summary

The investigators have created a new risk score that predicts whether initially stable patients with myocardial infarctions (heart attacks) will require intensive care while they are in the hospital. To evaluate how well this risk score works, the investigators plan to calculate this risk score for every patient that comes to the hospital with a heart attack, provide the risk score to the emergency room doctor treating the patient, and determine whether each patient required intensive care while they were in the hospital. The investigators will then evaluate whether giving emergency room doctors access to this risk score reduced costs of taking care of heart attack patients compared with previous years.

Read the detailed description

Multiple recent studies have demonstrated considerable between-hospital variability in ICU utilization for stable patients with NSTEMI and a lack of association between higher hospital-level ICU utilization and short-term mortality. Moreover, severity of illness, as measured by a traditional in-hospital mortality risk score, has only a trivial correlation with ICU utilization. A minority of initially stable patients with NSTEMI (\~15%) deteriorates clinically while hospitalized and requires ICU care for management of cardiac arrest, shock, arrhythmias requiring pacing, stroke, or respiratory failure. Across a variety of conditions outcomes are better when patients are admitted directly to the ICU from the emergency department (ED) rather than transferred in after admission. However, the cost of caring for patients in the ICU is substantially more than the cost of caring for these patients in a non-ICU environment. Furthermore, treating patients that do not require intensive care in the ICU exposes them to unnecessary risks of ICU care, including medication errors, adverse procedural outcomes, delirium, and excessive noise. Reducing ICU utilization for stable patients with NSTEMI may reduce costs and improve patient satisfaction.

Using data from a nationally-representative registry enrolling patients with acute MI, the investigators developed the ACTION ICU risk score. Incorporating demographic, clinical, and laboratory data obtained routinely in the ED work-up of patients with suspected acute MI, the ACTION ICU risk score calculates the risk of in-hospital complications mandating ICU care for initially stable patients with NSTEMI. Complications mandating ICU care were defined as death, shock (cardiogenic or otherwise), cardiac arrest, high degree heart block requiring pacemaker placement, respiratory failure, or stroke. The risk score's c-statistic was 0.72, indicating good discrimination. Importantly, it identified > 50% of patients as being at \< 10% risk of in-hospital complications mandating ICU care.

However, the clinical and financial implications of using this score to guide ICU triage in routine clinical practice are unknown, and the risk score has not been prospectively validated.

The investigators will create a calculator for the electronic health record that automatically calculates the ACTION ICU risk score for all patients with NSTEMI, as identified by their initial troponin value. Once the score is calculated, it will provide the score, and the patient's risk of clinical deterioration to the ED physician, along with a recommendation for where patients at that risk should be treated. The ED physician, working with the cardiologist on call, will then decide where the patient should be treated.

After one year, each patient for whom the score was calculated will be identified by a query of the electronic medical record. From the electronic medical record, the investigators will identify whether the patient was initially admitted to the ICU or to a non-ICU unit, whether the patient was transferred to the ICU during their hospital course, and whether the patient had clinical complications mandating ICU care (death, shock, cardiac arrest, heart block requiring pacemaker, stroke, or respiratory failure). The investigators will also compare total hospital costs for caring for NSTEMI patients before and after roll-out of the ACTION ICU score electronic medical record plug-in. Study completion will be defined by the last date of data extracted from the medical records for these patients.

03

Conditions studied

  • Non-ST Elevation Myocardial Infarction (nSTEMI)

Keywords

  • intensive care units
  • critical care
  • risk assessment
  • electronic health records
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients presenting to the Duke University Medical Center Emergency Department with elevated cardiac troponin

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Presents to DUMC with elevated cardiac troponin
  • Identified by ED physician as having myocardial infarction

Exclusion criteria

Exclusion Criteria:

  • ST segment elevation myocardial infarction
  • Hemodynamically unstable
05

Study design

Observational model
Cohort
Time perspective
Other
Enrollment
462 participants (actual)
Patient registry
No

Groups and cohorts

  • Patients with NSTEMI

    All patients admitted to Duke University Hospital with an NSTEMI

    Other: Admission with NSTEMI

Interventions

  • OtherAdmission with NSTEMI

    All patients admitted to Duke University Hospital with an NSTEMI

06

What researchers measure

Primary outcomes

  1. Hospital cost in dollars

    Cost of caring for NSTEMI patients at Duke University Hospital in the 1 year prior to roll-out of the risk score versus the 1 year after

    Time frame: 1 year

Secondary outcomes

  1. ICU transfer

    Whether a patient initially admitted to a non-ICU setting is transferred to the ICU during the index hospitalization

    Time frame: 30 days

  2. Development of complications mandating ICU care during the index hospitalization

    Composite of death or development of shock, cardiac arrest, heart block requiring treatment, stroke, or respiratory failure (as identified by billing codes)

    Time frame: 30 days

  3. Death during the index hospitalization

    Element of composite of "complications mandating ICU care"

    Time frame: 30 days

  4. Shock during the index hospitalization

    Element of composite of "complications mandating ICU care"; defined by billing codes

    Time frame: 30 days

  5. Cardiac arrest during the index hospitalization

    Element of composite of "complications mandating ICU care"; defined by billing codes

    Time frame: 30 days

  6. Heart block requiring treatment during the index hospitalization

    Element of composite of "complications mandating ICU care"; defined by billing codes

    Time frame: 30 days

  7. Stroke during the index hospitalization

    Element of composite of "complications mandating ICU care"; defined by billing codes

    Time frame: 30 days

  8. Respiratory failure during the index hospitalization

    Element of composite of "complications mandating ICU care"; defined by billing codes

    Time frame: 30 days

07

Study locations

1 site
  • Duke University
    Durham, North Carolina 27705, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Feb 2018 to primary completion in Aug 2019, 18 months.

Of 54 non-industry observational studies under Non-ST Elevated Myocardial Infarction, half reached primary completion within 40 months of starting (the median), counting those still running; a quarter within 15 and three quarters within 86. This study's 18 months is below that.

Counting every sponsor, half of 76 studies reached it within 32 months; a quarter within 19 and three quarters within 49.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 28, 2017
First posted
Jan 4, 2018
StartActual
Feb 14, 2018
Primary completionActual
Aug 31, 2019
CompletionActual
Aug 31, 2019
Last update
Sep 30, 2019
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 30, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03390270
Lead sponsor
Duke University
Responsible party
Sponsor
First posted
Jan 4, 2018
Start date
Feb 14, 2018
Primary completion
Aug 31, 2019
Completion
Aug 31, 2019
Last update
Sep 30, 2019

Study contacts

Alexander Fanaroff, MD
principal investigator · Duke University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2019. You cannot join it, but the record below documents what was studied.

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