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临床试验/NCT03619733
NCT03619733Unknown不适用

Does Modified Heart Score Incorporating Undetectable and 99th Percentile High Sensitivity Troponin T Limits Improve Early, Safe Discharge for Suspected Acute Coronary Syndromes

Liverpool University Hospitals NHS Foundation Trust2 个研究点 分布在 1 个国家目标入组 1,100 人开始时间: 2018年6月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
1,100
试验地点
2
主要终点
incidence of Major adverse cardiac event for patients with HEART score<=3

研究概览

简要总结

Validation of modified HEART score as a rule-out criterion for MACE at 6 weeks: a 2 centre prospective observational cohort with a direct comparison to TIMI, GRACE and high sensitive troponin T at limits of detection

Detailed description:

The HEART score, as defined previously by Backus et al1, is a risk score specifically developed for acute chest pain/ suspected acute coronary syndrome. The conventional scoring system for the troponin component of HEART is as follows: Troponin <99th percentile =0 (in the case of Hstn T [Roche} 14ng/l, 99th percentile up to X3 URL (99th percentile)= 1 (HSTN T =14-42ng/L, >x3 URN =2 (HSTN T >42ng/l).

We have previously defined that the optimal rule-out strategy for suspected acute coronary syndromes may well be a modified HEART score in a single centre study. This study is to prospectively validate the use of this score in a prospective unselected cohort of patients with possible acute coronary syndrome at 2 large secondary care centres

详细描述

Validation of modified HEART score as a rule-out criterion for MACE at 6 weeks: a 2 centre prospective observational cohort with a direct comparison to TIMI, GRACE and high sensitive troponin T at limits of detection

Detailed description:

The HEART score, as defined previously by Backus et al1, is a risk score specifically developed for acute chest pain/ suspected acute coronary syndrome. The conventional scoring system for the troponin component of HEART is as follows: Troponin <99th percentile =0 (in the case of Hstn T [Roche} 14ng/l, 99th percentile up to X3 URL (99th percentile)= 1 (HSTN T =14-42ng/L, >x3 URN =2 (HSTN T >42ng/l).

the investigators previously defined that the optimal rule-out strategy for suspected acute coronary syndromes may well be a modified HEART score in a single centre study. This study is to prospectively validate the use of this score in a prospective unselected cohort of patients with possible acute coronary syndrome at 2 large secondary care centres. The second centre (Royal Liverpool University Hospital) was external to where the initial cohort of 1642 patients were assessed that defined modified HEART as the optimal score.

The modified HEART score is as follows: HEART score can be re-calibrated (modified HEART) to undetectable hstnT and 99th percentile limits (<5= 0, ≥5-14=1, >14=2).

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

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

入选标准

  • consecutive presentations to A&E at 2 major urban hospital swith chest pain that the clinicans feel warrants a biomarker check for myocyte necrosis (high sensitive troponin) and presentation ECG

排除标准

  • primary presentation not chest pain
  • clear noncardiac cause of chest pain such as trauma life expectancy <1 year due to noncardiac pathology

结局指标

主要结局

incidence of Major adverse cardiac event for patients with HEART score<=3

时间窗: 6 weeks

adjudicated myocardial infarction, urgent or emergency coronary revascularisation, all-cause Death

次要结局

  • incidence of acute myocardial infarction for patients with HEART <=3(6 weeks)

研究者

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

Aleem Khand

cosultant interventional cardiologist

Liverpool University Hospitals NHS Foundation Trust

研究点 (2)

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