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2D Strain Echocardiography for Diagnosing Chest Pain in the Emergency Room (2DSPER)

2014年10月27日 更新者:Avinoam Shiran、Technion, Israel Institute of Technology

Utility of 2D Strain Echocardiography in Triage of Patients With Chest Pain in the Emergency Department

Background: Chest pain (CP) and suspected heart attack is the second most frequent complaint among patients presenting to the emergency department (ED). Present workup involves in-hospital observation for 6 - 48 hours and requires significant resources including imaging tests, some of which are invasive and involve radiation and radio-contrast agents, which can be toxic to the kidney.

CP can result from impaired blood supply to the heart muscle, which may result in impaired contraction of the heart that persists for several days. Bedside echocardiography with semi-automated speckle tracking strain analysis (2D strain) is a novel promising noninvasive tool for the evaluation of heart muscle contraction. 2D strain can be useful for evaluating patients with CP, since it can accurately detect minor impairment in heart muscle contraction that can identify patients with coronary artery disease (CAD) and impending heart attack (coronary arteries are the arteries supplying blood to the heart muscle).

Working hypothesis and aims: The investigators hypothesize that a bedside echo study with normal 2D strain may allow quick and safe ruling out of a heart attack and significant CAD disease as the cause of CP.

The main aim of the study is to validate the investigators preliminary findings in a large number of patients in order to establish whether a normal 2D strain can safely rule out a heart attack or life threatening CAD.

Methods: In a large multi-center study 1200 patients presenting to the ED with acute CP of an unclear cause will undergo echocardiography as close as possible to presentation and not more than 24 hours from cessation of pain. Patients will undergo standard workup by the ED physicians. Standard echocardiographic findings, but not the 2D strain analysis, will be made available to the attending physician. Data from discharge letters, ECGs, blood tests, stress tests, nuclear imaging, heart CT and heart catheterization will be collected. A 6-month follow-up telephone interview will be performed to collect data on survival, heart attacks, re-hospitalization and revascularization (opening heart vessels blockages). 2D strain analysis will be performed off-line in a central laboratory to evaluate the ability of 2D strain to distinguish between patients with CP from heart disease and patients without life threatening heart disease that can be early released home safely.

Expected results: The investigators expect, based on the investigators previous experience, that patients with normal 2D strain will have a very low probability of a heart attack and significant CAD. The investigators further expect these patients to have an excellent 6-month prognosis. This will allow their early and cost-effective discharge.

Importance and Probable implications to Medicine: Reduction in ED patient load and a decrease in unnecessary hospitalizations for CP. Cost and resource savings and elimination of unnecessary imaging studies, some of which are invasive or involve radiation and contrast agents.

研究概览

研究类型

观察性的

注册 (实际的)

700

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

      • Afula、以色列
        • Ha'Emek Medical Center,
      • Beer Sheva、以色列
        • Soroka University Medical Center
      • Hadera、以色列
        • Hillel Yafe Medical Center
      • Haifa、以色列
        • Lady Davis Carmel Medical Center
      • Jerusalem、以色列
        • Shaare Zedek Medical Center
      • Jerusalem、以色列
        • Hadassah-Hebrew University Medical Center, Mount Scopus
      • Jerusalem、以色列
        • Hadassah-University Medical Center, Ein Kerem
      • Petah Tikva、以色列
        • Rabin Medical Center
      • Rehovot、以色列
        • Kaplan Medical Center
      • Tel Hashomer、以色列
        • Chaim Sheba Medical Center
      • Zrifin、以色列
        • Assaf Harofeh Medical Center

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

45年 及以上 (成人、年长者)

接受健康志愿者

有资格学习的性别

全部

取样方法

非概率样本

研究人群

Patients presenting to the emergency department with a chief complaint of chest pain

描述

Inclusion Criteria:

  1. Patients presenting to the emergency department with chest pain characteristic for ischemia and suspected acute coronary syndrome and at least one of the following:

    • Planned emergency department or chest pain unit observation for at least 6 hours
    • Hospital or chest pain unit admission for suspected acute coronary syndrome
    • Planned coronary CT scan
  2. Age ≥ 45 years old
  3. Normal sinus rhythm
  4. Patient able to give an informed consent

Exclusion Criteria:

  1. ST elevation MI (≥ 1mm in at least 2 contiguous leads) or unstable patients requiring urgent care
  2. Significant (≥ 1mm ST depression in at least 2 contiguous leads) on initial ECG
  3. Elevated troponin on first examination
  4. History of previous MI, CABG, significant Q waves on ECG or wall motion abnormality on a previous echo
  5. Atrial fibrillation or abundant arrhythmia
  6. CLBBB, Ventricular pacing
  7. Valvular disease of at least moderate severity
  8. Cardiomyopathy
  9. Abnormal septal motion due to right ventricular disease or lung disease
  10. Technically suboptimal echo study (> 2 segments of suboptimal quality from apical views)
  11. Pregnancy
  12. Inadequate strain tracing

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

队列和干预

团体/队列
Chest pain
Patients who present to the emergency department with a chief complaint of chest pain and have a moderate pre-test probability for an acute coronary syndrome

研究衡量的是什么?

主要结果指标

结果测量
大体时间
Acute coronary syndrome
大体时间:1 week
1 week
Significant coronary artery disease.
大体时间:1 week
1 week

次要结果测量

结果测量
大体时间
Major adverse cardiac events (MACE - death, MI or revascularization)
大体时间:6 months
6 months

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Avinoam Shiran, MD、Lady Davis Carmel Medical Center, Technion, Israel Institute of Technology

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2010年9月1日

初级完成 (实际的)

2014年2月1日

研究完成 (实际的)

2014年9月1日

研究注册日期

首次提交

2010年7月12日

首先提交符合 QC 标准的

2010年7月14日

首次发布 (估计)

2010年7月15日

研究记录更新

最后更新发布 (估计)

2014年10月28日

上次提交的符合 QC 标准的更新

2014年10月27日

最后验证

2014年10月1日

更多信息

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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