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Completed

NCT Number: NCT03058120

Henry Ford Heart Score Randomized Trial: Rapid Discharge of Patients Evaluated for Possible Myocardial Infarction

This was a prospective randomized, controlled trial designed to quantify the reduction in cost and length of stay of early discharge of emergency department patients evaluated for acute myocardial infarction, who are deemed to be low risk based on a modified HEART score (a score that incorporates troponin biomarker, ecg, patient characteristics, and physician clinical judgment).

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Key information

About this study

This was a prospective randomized, controlled trial conducted from February 2014 to May 2015 designed to quantify the reduction in cost and length of stay of early discharge of emergency department patients evaluated for acute myocardial infarction, in those deemed to be low risk based on a modified HEART score. Our study enrolled only those deemed low risk, as these are the patients we believe best served by utilization of the HEART score decision aid.

A total of 105 patients evaluated for AMI in the ED with a modified HEART score ≤ 3 (which includes cardiac troponin I < 0.04 ng/ml at 0 and 3 hours) were randomized to immediate discharge (n = 53) vs management in an observation unit with stress testing (n = 52).

The primary endpoints were 30-day total cost and length of stay. Secondary endpoints were all-cause death, nonfatal AMI, rehospitalization for evaluation of possible AMI, and coronary revascularization at 30 days.

That such an early discharge strategy would decrease cost and length of stay is intuitively expected; our goal was to quantify such a reduction.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • patients 21 years or older
  • patients who presented to the Emergency Department with symptoms suspicious for AMI.
  • patients for whom the ED physician's intention to send the patient to the observation unit for stress testing

Exclusion criteria

  • Cardiac Troponin I > 0.04 ng/mL at 0 or 3 hours
  • clinical presentation warranting admission
  • inability or unwillingness to consent
  • trauma as etiology of presenting symptoms.

Treatment and study plan

Deferral of admission for stress test

Other

Early discharge; admission and stress test are deferred.

Primary outcomes

  1. Cost of hospitalization

    Time frame: 30 days

    Total charges accrued during index hospitalization, as well as costs related to index hospitalization up to 30 days after index discharge

  2. Length of stay

    Time frame: up to 1 week

    Total length of stay of index hospitalization

Secondary outcomes

  1. 30-day MACE

    Time frame: 30 days after index hospitalization

    Death, non-fatal myocardial infarction, stroke

Sponsors and collaborators

Lead sponsor

Henry Ford Health System

Other

Registry information

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Feb 20, 2017
Registry last updated
Feb 20, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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