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

Coronary Artery Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03058120
• Other study ID #: IRB 8558
• Status: Completed
• Phase: N/A
• First received: February 14, 2017
• Last updated: February 15, 2017
• Start date: February 19, 2014
• Est. completion date: May 8, 2015

Study information

• Verified date: February 2017
• Source: Henry Ford Health System
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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).

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 105
• Est. completion date: May 8, 2015
• Est. primary completion date: May 8, 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Chest Pain
• Coronary Artery Disease
• Coronary Disease
• Heart Attack
• Infarction
• Myocardial Infarction
• Myocardial Ischemia

Intervention

Other:
• Deferral of admission for stress test
Early discharge; admission and stress test are deferred.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Henry Ford Health System

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cost of hospitalization	Total charges accrued during index hospitalization, as well as costs related to index hospitalization up to 30 days after index discharge	30 days
Primary	Length of stay	Total length of stay of index hospitalization	up to 1 week
Secondary	30-day MACE	Death, non-fatal myocardial infarction, stroke	30 days after index hospitalization