跳至主要内容
临床试验/NCT02984436
NCT02984436已完成不适用

High-Sensitivity Cardiac Troponin T to OPtimize Chest Pain Risk Stratification

University of Florida6 个研究点 分布在 1 个国家目标入组 1,572 人开始时间: 2017年1月25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
1,572
试验地点
6
主要终点
Cardiac Troponin T (cTn)

研究概览

简要总结

This is a prospective observational cohort study of ED patients with acute chest pain or other symptoms suggestive of ACS. Blood samples will be collected from study participants for High-Sensitivity Cardiac Troponin T (hs-cTnT) analysis. Results from hs-cTnT will be used for research purposes only.

Providers will be blinded to results and participants will be treated by their healthcare providers per the standard of care. Participants will have 30 and 90 day phone follow-ups to ascertain study outcomes.

详细描述

Approximately 8 million - 10 million patients complaining of chest pain present to an Emergency Department (ED) annually in the United States. To avoid missing the diagnosis of acute coronary syndrome (ACS), physicians use a liberal testing strategy. Thus, >50% of ED patients with acute chest pain are hospitalized for a comprehensive cardiac evaluation (serial cardiac biomarkers and stress testing or angiography). However, <10% of these patients are ultimately diagnosed with ACS, and this pervasive over-triage costs an estimated $10 billion - $13 billion annually. Current care patterns for acute chest pain fail to focus health system resources, such as hospitalization and stress testing, on patients most likely to benefit.

It has demonstrated that an accelerated diagnostic protocol (ADP), called the HEART Pathway, which utilizes a clinical decision aid (the HEART score) and serial Cardiac Troponin (cTn) measures are sensitive for ACS (>99%) and can substantially reduce hospitalizations, stress testing, and cost compared to usual care. The HEART Pathway uses contemporary serial cTn measurements at 0 and 3 hours to exclude index myocardial infarction (MI) and relies on clinical features (history, ECG, age, and risk factors) to identify patients likely to have downstream events. However, the HEART Pathway has limitations: a) It identifies only 20 - 40% of patients for early discharge and b) it was developed before high-sensitivity cTn assays became available. Able to detect MI earlier and with greater accuracy than contemporary assays, hs-cTn assays have the potential to be integrated into decision aids to improve chest pain risk stratification. In the near future, hs-cTn assays will replace contemporary assays in the United States.

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

入选标准

  • Age greater than or equal to 21 years at the time of enrollment in the ED
  • Chest discomfort or other symptoms consistent with possible ACS in which the treating physician plans to obtain an ECG and cTn for the patient's evaluation in the ED

排除标准

  • New ST-segment elevation consistent with myocardial infarction
  • Evidence of shock identified by the provider at the bedside and/or the PI
  • Terminal diagnosis with life expectancy less than 90 days
  • A non-cardiac medical, surgical, or psychiatric illness determined by the provider to require admission
  • Prior enrollment in the STOP CP study
  • Lack of capacity to provide consent and comply with study procedures
  • Inability to be reliably reached after the index visit for follow-up
  • Non-English speaking
  • Pregnant patients
  • Provider does not intend on obtaining serial cTn assays for evaluation of ACS
  • The first study draw (T0) will exceed 1 hour after the site-specific standard of care troponin draw
  • Unable or unwilling to authorize medical records release

结局指标

主要结局

Cardiac Troponin T (cTn)

时间窗: 3 hours

Site-specific cTn will be measured at 3 hours unless baseline site-specific cTn tests positive

High Sensitivity Cardiac Troponin T using lithium heparin tubes

时间窗: 3 hours after baseline

The research team will obtain two lithium heparin tubes at baseline, 1, 2, and 3 hours for sampling and preparation for shipping to the core laboratory in Maryland for hs-cTnT processing. Providers will be blinded to hs-cTnT results.

High Sensitivity Cardiac Troponin T using EDTA tubes

时间窗: 3 hours after baseline

The research team will obtain one EDTA tube at baseline, 1, 2, and 3 hours for sampling and preparation for shipping to the core laboratory in Maryland for hs-cTnT processing. Providers will be blinded to hs-cTnT results.

Occurrence of major adverse cardiac events (MACE)

时间窗: 90 days

次要结局

  • Incidence and Intensity of Adverse Events(Change from Baseline, 1, 2, 3 hours. 30 days and 90 days post discharge)
  • HEART Score Calculation(Change from Baseline, 1, 2, 3 hours. 30 days and 90 days post discharge)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (6)

Loading locations...

相似试验