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

NCT03058120 | Completed

• 1 other identifier: IRB 8558
• Study Type: interventional
• Target: 105
• Locations: 0 countries
• Sites: N/A

Brief 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).

Conditions

Chest Pain; Heart Attack; Coronary Artery Disease

Outcome Measures

Primary Outcomes (2)

• 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

• Length of stay

  Total length of stay of index hospitalization

  up to 1 week

Secondary Outcomes (1)

• 30-day MACE

  30 days after index hospitalization

Study Arms (2)

Stress testing

NO INTERVENTION

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.

Early discharge

ACTIVE COMPARATOR

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

Other: Deferral of admission for stress test

Interventions

Deferral of admission for stress test OTHER

Early discharge; admission and stress test are deferred.

Early discharge

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Henry Ford Health System: lead

Related Publications (1)

• 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.

  PMID: 28954802 DERIVED

MeSH Terms

Conditions

Chest Pain; Myocardial Infarction; Coronary Artery Disease

Interventions

Exercise Test

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Necrosis; Coronary Disease; Arteriosclerosis; Arterial Occlusive Diseases

Intervention Hierarchy (Ancestors)

Heart Function Tests; Diagnostic Techniques, Cardiovascular; Diagnostic Techniques and Procedures; Diagnosis; Respiratory Function Tests; Diagnostic Techniques, Respiratory System; Ergometry; Investigative Techniques

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, Member of Heart and Vascular Institute in the Division of Cardiology

Study Record Dates

• First Submitted: February 14, 2017
• First Posted: February 20, 2017
• Study Start: February 19, 2014
• Primary Completion: May 8, 2015
• Study Completion: May 8, 2015
• Last Updated: February 20, 2017

Record last verified: 2017-02

Data Sharing

• IPD Sharing: Will not share