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临床试验/NCT03058120
NCT03058120已完成不适用

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

Henry Ford Health System0 个研究点目标入组 105 人开始时间: 2014年2月19日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
105
主要终点
Cost of hospitalization

研究概览

简要总结

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).

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Single (Investigator)

入排标准

年龄范围
21 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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.

结局指标

主要结局

Cost of hospitalization

时间窗: 30 days

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

Length of stay

时间窗: up to 1 week

Total length of stay of index hospitalization

次要结局

  • 30-day MACE(30 days after index hospitalization)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Tiberio Frisoli

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

Henry Ford Health System

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