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临床试验/NCT04022668
NCT04022668已完成不适用

Diagnostic Accuracy of Electrocardiogram for Acute Coronary Occlusion

Yeditepe University1 个研究点 分布在 1 个国家目标入组 3,000 人开始时间: 2017年5月1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
3,000
试验地点
1
主要终点
The Sensitivity and Specificity of ECG for Acute Coronary Occlusion.

研究概览

简要总结

The decision of emergency reperfusion of a suspected acute coronary artery occlusion by means of percutaneous coronary intervention or intravenous thrombolytics depends on the presence of a certain amount of ST-segment elevation in the electrocardiogram (ECG) as recommended by international guidelines. However, recommended ST-segment elevation cut-off values for acute coronary occlusion diagnosis are highly insensitive, and their evidence base is weak. The objective of this study is to test the accuracy of various electrocardiographic patterns (including, but not limited to, ST-segment elevation) for the diagnosis of acute coronary occlusion. This information can serve to offer an accuracy profile for various ECG findings and enable clinicians to define the ECG probability of an acute coronary occlusion according to these ECG findings and clinical picture, which in turn would provide a significant improvement in the care for patients who present to the hospital with possible coronary occlusion. The primary analysis will be designed as a single-center, retrospective case-control study.

详细描述

In this retrospective, single-center, case-control study the investigators will seek to compare the diagnostic accuracy of various ECG criteria to identify acute coronary occlusion (ACO). The investigators will scan the charts of the patients presenting to emergency department with a clinical picture suggestive of acute coronary syndrome in the specified time period. Patients without any admission ECG will be excluded. Patients who had a final diagnosis of myocardial infarction (MI) with or without subsequent coronary intervention will be enrolled. These patients will be classified as ST-segment elevation (STEMI) group or non-ST-segment elevation (NSTEMI) group according to their final diagnosis. Patient who had been excluded for acute coronary syndrome with serial unchanging ECGs AND negative serial troponins will constitute a third group. Allocation to each group will be continued until the patient number in each group reaches up to 1000 patients. The dead or alive status of all included patients will be checked from the electronic national database.

All ECGs will be reviewed by two cardiologists blinded to the angiographic and clinical outcomes. The presence of predefined ECG findings of ACO (including, but not limited to, current established STEMI criteria) will be recorded. The coronary angiograms of the first two groups will be reviewed for ACO by independent investigators who are blinded to ECG parameters. The diagnosis of acute coronary occlusion will be dependent upon angiographic occlusion and rising cardiac biomarker levels. Because in some cases of ACO, the artery may spontaneously open by the time of the angiogram, the investigators will need to have surrogate endpoints: this will be culprit lesion OR acute occlusion on the angiogram AND a sufficiently elevated peak troponin, i.e., peak troponin I > 1.0 ng/mL with a 20% change within first 24 hours OR peak troponin T > 5.0 ng/mL, which have been shown to be highly correlated with ACO OR cardiac arrest in a clinical scenario compatible with ACO before blood could be withdrawn for troponin essay.

The sensitivity, specificity and diagnostic accuracy of all these predefined ECG criteria will be sought. Also, sensitivity, specificity and diagnostic accuracy of current established STEMI criteria will be defined. Both short- and long-term mortality of the patients with a diagnosis of STEMI with ACO, STEMI without ACO, NSTEMI with ACO, NSTEMI without ACO and chest pain without acute coronary syndrome will be compared.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Retrospective

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

  • Admission to emergency department with a clinical picture suggestive of acute coronary syndrome

排除标准

  • Absence of documented ECG
  • Age <18 years

结局指标

主要结局

The Sensitivity and Specificity of ECG for Acute Coronary Occlusion.

时间窗: Up to 48 hours

Determine the sensitivity and specificity of different ECG findings for acute coronary occlusion. The Number of Participants with Type 1a and 1b ECGs, as defined in the study protocol.

次要结局

  • The Outcome (Mortality) According to ECG Subclassifications (STEMI/NSTEMI/Control Groups)(Up to one year)
  • The Sensitivity and Specificity of Current "STEMI" Criteria for Acute Coronary Occlusion.(Up to 48 hours)
  • The Specificity of ECG With STEMI Criteria(Up to 48 hours)
  • The Sensitivity of ECG With STEMI Criteria(Up to 48 hours)
  • The Sensitivity and Specificity of ECG Without ST-segment Elevation for Acute Coronary Occlusion(Up to 48 hours)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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