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

NCT ID: NCT03058120

Last Updated: 2017-02-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

105 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-02-19

Study Completion Date

2015-05-08

Brief Summary

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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).

Detailed Description

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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.

Conditions

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Chest Pain Heart Attack Coronary Artery Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Investigators

Study Groups

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Stress testing

Patient with chest pain, low risk by modified HEART score, undergoes whatever admission and stress testing plan is determined by ED and inheriting decision unit physicians.

Group Type NO_INTERVENTION

No interventions assigned to this group

Early discharge

Patient with chest pain, low risk by modified HEART score, is discharged from the emergency room without admission nor stress testing.

Group Type ACTIVE_COMPARATOR

Deferral of admission for stress test

Intervention Type OTHER

Early discharge; admission and stress test are deferred.

Interventions

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Deferral of admission for stress test

Early discharge; admission and stress test are deferred.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Henry Ford Health System

OTHER

Sponsor Role lead

Responsible Party

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Tiberio Frisoli

MD, Member of Heart and Vascular Institute in the Division of Cardiology

Responsibility Role PRINCIPAL_INVESTIGATOR

References

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Frisoli TM, Nowak R, Evans KL, Harrison M, Alani M, Varghese S, Rahman M, Noll S, Flannery KR, Michaels A, Tabaku M, Jacobsen G, McCord J. Henry Ford HEART Score Randomized Trial: Rapid Discharge of Patients Evaluated for Possible Myocardial Infarction. Circ Cardiovasc Qual Outcomes. 2017 Oct;10(10):e003617. doi: 10.1161/CIRCOUTCOMES.117.003617.

Reference Type DERIVED
PMID: 28954802 (View on PubMed)

Other Identifiers

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IRB 8558

Identifier Type: -

Identifier Source: org_study_id

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