NCT03390270

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
462

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 28, 2017

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 4, 2018

Completed
1 month until next milestone

Study Start

First participant enrolled

February 14, 2018

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2019

Completed
Last Updated

September 30, 2019

Status Verified

September 1, 2019

Enrollment Period

1.5 years

First QC Date

December 28, 2017

Last Update Submit

September 27, 2019

Conditions

Keywords

intensive care unitscritical carerisk assessmentelectronic health records

Outcome Measures

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

    1 year

Secondary Outcomes (8)

  • ICU transfer

    30 days

  • Development of complications mandating ICU care during the index hospitalization

    30 days

  • Death during the index hospitalization

    30 days

  • Shock during the index hospitalization

    30 days

  • Cardiac arrest during the index hospitalization

    30 days

  • +3 more secondary outcomes

Study Arms (1)

Patients with NSTEMI

All patients admitted to Duke University Hospital with an NSTEMI

Other: Admission with NSTEMI

Interventions

All patients admitted to Duke University Hospital with an NSTEMI

Patients with NSTEMI

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • ST segment elevation myocardial infarction
  • Hemodynamically unstable

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Duke University

Durham, North Carolina, 27705, United States

Location

MeSH Terms

Conditions

Non-ST Elevated Myocardial Infarction

Condition Hierarchy (Ancestors)

Myocardial InfarctionMyocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Study Officials

  • Alexander Fanaroff, MD

    Duke University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 28, 2017

First Posted

January 4, 2018

Study Start

February 14, 2018

Primary Completion

August 31, 2019

Study Completion

August 31, 2019

Last Updated

September 30, 2019

Record last verified: 2019-09

Data Sharing

IPD Sharing
Will not share

Locations