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临床试验/NCT03863327
NCT03863327Unknown不适用

EKG Criteria and Identification of Acute Coronary Occlusion

Stony Brook University2 个研究点 分布在 1 个国家目标入组 2,000 人开始时间: 2018年5月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
2,000
试验地点
2
主要终点
The difference in time to diagnosis of acute coronary occlusion (ACO) between the current standard of care and advanced human ECG interpretation in patients with confirmed occlusive myocardial infarction without ST elevation myocardial infarction

研究概览

简要总结

The objective of this research study is to test the accuracy of preexisting criteria versus expert interpretation for the diagnosis of acute coronary occlusion (major heart attack due to a completely blocked blood vessel). If our hypothesis proves to be true, this would provide a significant improvement in the care for patients who present to the hospital with possible symptoms of coronary ischemia (symptoms due to lack of blood flow to the heart).

The primary analysis will be designed as a multi-center, retrospective case-control study.

详细描述

In this retrospective, 2-center, case-control study the investigators will investigate and compare the accuracy of various ECG criteria and expert interpretation to diagnose Acute Coronary Occlusion (ACO), with an emphasis on the diagnosis of patients with ACO but without obvious ST segment Elevation Myocardial Infarction (STEMI) criteria. The investigators will use two cohorts of patients who present with symptoms consistent with acute MI, one subsequently proven to have ACO and one proven to not have ACO.

The groups will be identified by chart reviewers who will use all clinical data except the ECGs to determine, in retrospect, and using strict criteria, if the patient had ACO at the time of the ECGs to be evaluated, or not. These reviewers will be blinded to all ECGs. The diagnosis of ACO will be dependent upon angiographic occlusion. Because in many cases of ACO, the artery spontaneously opens by the time of the angiogram, the investigators will need to have surrogate endpoints: this will be culprit on the angiogram PLUS a very elevated peak troponin, as peak troponin I > 10.0 ng/mL and peak troponin T > 1.0 ng/mL are highly correlated with ACO.

The investigators will find cases of subtle STEMI (ACO without STEMI criteria) by searching for all myocardial infarction cases that underwent angiography and percutaneous coronary intervention (PCI). The investigators will attempt by various criteria to determine from all available sources other than the ECG (angiography, echo, troponins) whether the involved artery was occluded at the time of the most diagnostic ECG that was recorded while the patient had symptoms and before the angiogram. Reviewers determining ACO or not ACO will be blinded to the ECGs. The investigators will use each pre-angiogram ECG, in sequence, for analysis, to determine if expert interpretation can not only identify occlusion that is not identified by STEMI criteria, but also to find if expert interpretation can identify occlusion on an earlier ECG. Expert ECG interpreters will interpret the ECG for evidence of ACO. Their accuracy will be compared to traditional STEMI criteria and other methods of interpretation if available.

The investigators will use as controls patients with any ST elevation, or ST depression, of any etiology that are proven to NOT have occlusion. The investigators will establish absence of occlusion by a combination of objective data points including angiogram (if performed), troponins, echocardiograms, clinical course, etc. Details of the methods are below, including specific outcome definitions used to claim the presence or absence of ACO.

研究设计

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

入排标准

性别
All
接受健康志愿者

入选标准

  • Recorded EKG prior to cardiac catheterization

排除标准

  • Absence of documented EKG prior to cardiac catheterization

结局指标

主要结局

The difference in time to diagnosis of acute coronary occlusion (ACO) between the current standard of care and advanced human ECG interpretation in patients with confirmed occlusive myocardial infarction without ST elevation myocardial infarction

时间窗: 1 year

How long does it take for an expert human ECG interpreter to diagnose ACO compared to the standard of care utilizing STEMI criteria

次要结局

  • The difference in sensitivity among the occlusive myocardial infarction (OMI) cohort for experts versus ST elevation myocardial infarction (STEMI) criteria in patients with widened QRS(1 year)
  • The difference in sensitivity among the occlusive myocardial infarction (OMI) cohort for experts versus ST elevation myocardial infarction (STEMI) criteria(1 year)
  • The difference in sensitivity among the occlusive myocardial infarction (OMI) cohort for experts versus ST elevation myocardial infarction (STEMI) criteria in all studied patients(1 year)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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