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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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.
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.
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 →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:
University of South Florida · Sites in United States
Ages 18+
Baim Institute for Clinical Research · Sites in United States
Ages 18+
SB Technology, Inc. · Sites in United States
Ages 22+
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 →
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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45 studies; the count open now beside each. This study's row is marked.
First in 2005; this study’s year is marked. 4 started in 2018.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 462 is below the median of 525 across 130 observational studies indexed under Non-ST Elevated Myocardial Infarction.
Median enrollment 500 across the 27 interventional studies, 406 across the 18 observational. Of the 31 that completed or were terminated, 15 (48%) have results posted.
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19 of 45 have an industry lead sponsor. The 10 most frequent:
Duke University is the lead sponsor of 2,063 studies on the registry; 272 are open to participants now.
Of its 204 completed or terminated interventional studies of FDA-regulated products, 167 (82%) have results posted.
Duke University has 1 study filed under Non-ST Elevated Myocardial Infarction — fewer than ten, so there is no comparison to draw.
4 of the studies in Non-ST Elevated Myocardial Infarction with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05800951Henry Ford Health SystemCan Escalation Reduce Acute Myocardial Infarction Mortality in Cardiogenic Shock | 2026-12-31 |
| NCT07822581SB Technology, Inc."Discovery2" Study of Using MCG at Emergency Departments | 2027-02-28 |
| NCT05284747AmgenEVOLVE-MI: EVOLocumab Very Early After Myocardial Infarction | 2027-05-29 |
| NCT05946629M.A. Med Alliance S.A.SELUTION 4 De Novo Small Vessel IDE Trial | 2027-09 |
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Among the 45 studies in Non-ST Elevated Myocardial Infarction with a site in United States, from their registry updates:
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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.
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.
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.
Exclusion Criteria:
All patients admitted to Duke University Hospital with an NSTEMI
Other: Admission with NSTEMI
All patients admitted to Duke University Hospital with an NSTEMI
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
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
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
Death during the index hospitalization
Element of composite of "complications mandating ICU care"
Time frame: 30 days
Shock during the index hospitalization
Element of composite of "complications mandating ICU care"; defined by billing codes
Time frame: 30 days
Cardiac arrest during the index hospitalization
Element of composite of "complications mandating ICU care"; defined by billing codes
Time frame: 30 days
Heart block requiring treatment during the index hospitalization
Element of composite of "complications mandating ICU care"; defined by billing codes
Time frame: 30 days
Stroke during the index hospitalization
Element of composite of "complications mandating ICU care"; defined by billing codes
Time frame: 30 days
Respiratory failure during the index hospitalization
Element of composite of "complications mandating ICU care"; defined by billing codes
Time frame: 30 days
Plan to share: No
No publications or documents are linked to this record.
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.
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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Non-ST Elevated Myocardial Infarction →