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

Primary Purpose

Chest Pain, Heart Attack, Coronary Artery Disease

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Deferral of admission for stress test
Sponsored by
Henry Ford Health System
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Chest Pain

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    No Intervention

    Active Comparator

    Arm Label

    Stress testing

    Early discharge

    Arm Description

    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.

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

    Outcomes

    Primary Outcome Measures

    Cost of hospitalization
    Total charges accrued during index hospitalization, as well as costs related to index hospitalization up to 30 days after index discharge
    Length of stay
    Total length of stay of index hospitalization

    Secondary Outcome Measures

    30-day MACE
    Death, non-fatal myocardial infarction, stroke

    Full Information

    First Posted
    February 14, 2017
    Last Updated
    February 15, 2017
    Sponsor
    Henry Ford Health System
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03058120
    Brief Title
    Henry Ford Heart Score Randomized Trial: Rapid Discharge of Patients Evaluated for Possible Myocardial Infarction
    Official Title
    Henry Ford Heart Score Randomized Trial: Rapid Discharge of Patients Evaluated for Possible Myocardial Infarction
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    February 19, 2014 (Actual)
    Primary Completion Date
    May 8, 2015 (Actual)
    Study Completion Date
    May 8, 2015 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Henry Ford Health System

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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).
    Detailed 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Chest Pain, Heart Attack, Coronary Artery Disease

    7. Study Design

    Primary Purpose
    Other
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Investigator
    Allocation
    Randomized
    Enrollment
    105 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Stress testing
    Arm Type
    No Intervention
    Arm Description
    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.
    Arm Title
    Early discharge
    Arm Type
    Active Comparator
    Arm Description
    Patient with chest pain, low risk by modified HEART score, is discharged from the emergency room without admission nor stress testing.
    Intervention Type
    Other
    Intervention Name(s)
    Deferral of admission for stress test
    Intervention Description
    Early discharge; admission and stress test are deferred.
    Primary Outcome Measure Information:
    Title
    Cost of hospitalization
    Description
    Total charges accrued during index hospitalization, as well as costs related to index hospitalization up to 30 days after index discharge
    Time Frame
    30 days
    Title
    Length of stay
    Description
    Total length of stay of index hospitalization
    Time Frame
    up to 1 week
    Secondary Outcome Measure Information:
    Title
    30-day MACE
    Description
    Death, non-fatal myocardial infarction, stroke
    Time Frame
    30 days after index hospitalization

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    21 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    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.

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    28954802
    Citation
    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.
    Results Reference
    derived

    Learn more about this trial

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

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