跳至主要内容
临床试验/NCT06570759
NCT06570759进行中(未招募)不适用

Time for a DIagnostic Paradigm Shift From ST-elevation/Non-ST-elevation to OCClUsion/Non-occLusion Myocardial infarcTion

Başakşehir Çam & Sakura City Hospital35 个研究点 分布在 1 个国家目标入组 6,000 人开始时间: 2024年10月1日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
6,000
试验地点
35
主要终点
Primary end point: Major adverse events (Mortality and rehospitalization)

研究概览

简要总结

The investigators hypothesize that occlusion myocardial infarction(MI)/non-occlusion MI approach to MI treatment will better predict acute coronary occlusion on coronary angiography, better limit infarct size, better preserve left ventricular function and result in lower long-term adverse cardiac events (all cause mortality, all cause rehospitalization) compared to standard ST-elevation/non-ST-elevation MI paradigm.

详细描述

I. BACKGROUND AND SIGNIFICANCE

The patients with acute coronary occlusion (ACO) or potentially imminent occlusion, with insufficient collateral circulation, have myocardium that is at risk of infarction unless they undergo immediate reperfusion via thrombolytics or percutaneous coronary intervention (PCI). One of the most important tasks in emergency cardiology is to immediately identify acute coronary occlusion (ACO) myocardial infarction (OMI) among all patients who present with symptoms compatible with acute myocardial infarction (MI), and distinguish them from those without MI, and from those with MI that does not have ongoing myocyte loss (Non-OMI, or NOMI) who can be managed with medical therapy and for whom potentially harmful invasive interventions can be deferred. The electrocardiogram (ECG) plays a central role in this process.

The presence or absence of ST-segment elevation (STE) is principally used to define patients who need emergent coronary revascularization, since subgroup analyses of the Fibrinolytic Therapy Trialists' (FTT) meta-analysis indicated that patients with STE on ECG gain a slightly better survival benefit from emergent reperfusion. After fine-tuning of STE cutoffs used in this analysis, universally agreed STEMI criteria became the current guideline-supported ECG paradigm.

It is not clear why a disease of a known pathophysiology (ACO) was named with an inaccurate surrogate ECG sign (Q-wave MI/non-Q-wave MI or STEMI/non-STEMI) instead of the pathologic substrate itself (ACO-MI/non-ACO-MI or OMI for short), but this fundamental mistake created important implications for our current practice. As briefly outlined above, ACO can be reliably recognized with the help of many other ECG findings, such as minor STE not fulfilling STEMI criteria, STE disproportionate to preceding QRS, unusual patterns with contiguous leads showing opposite ST deviations and some patterns not showing STE at all.

Recently, the DIagnostic accuracy oF electrocardiogram for acute coronary OCClUsion resuLTing in myocardial infarction (DIFOCCULT) study, compared OMI/non-OMI approach with STEMI/non-STEMI paradigm. This is the largest study specifically designed to question the STEMI/non-STEMI paradigm, in which a set of predefined ECG findings in addition to STEMI criteria were used, and the final outcome was a composite ACO endpoint. In accordance with the previous observations, over one-fourth of the patients initially classified as having non-STEMI were re-classified by the ECG reviewers, blinded to all outcome data, as having OMI. This subgroup had a higher frequency of ACO, myocardial damage, and both in-hospital and long-term mortality compared to the non-OMI group. The OMI/non-OMI approach to the ECG had a superior diagnostic accuracy compared to the STE/non-STEMI approach in the prediction of both ACO and long-term mortality.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
18 Years 至 99 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age >18 years
  • ECG and/or clinical diagnosis of acute myocardial infarction

排除标准

  • Active pregnancy or a suspicion of pregnancy
  • Rejection or withdrawal of consent
  • Failure to acquire any of the pre-participation ECGs
  • Non-ischemic myocardial injury
  • Application of thrombolytic therapy instead of primary PCI
  • Re-occlusion of the culprit lesion after intervention*
  • New vessel occlusion during hospital stay*
  • Exclusion from final analyses.

结局指标

主要结局

Primary end point: Major adverse events (Mortality and rehospitalization)

时间窗: One year

The difference in the combined rate of all-cause mortality, all-cause

Primary end point: Major adverse events (Mortality and rehospitalization) in STEMI (-) OMI (+) subgroup

时间窗: One year

The dual-primary endpoint is all-cause mortality and all-cause re-hospitalization in OMI (+) STEMI (-) patient subgroups.

次要结局

  • Secondary end point: Short-term major cardiovascular events(One month)
  • Secondary end point: Diagnosis of acute coronary occlusion(One week)

研究者

发起方
Başakşehir Çam & Sakura City Hospital
申办方类型
Other Gov
责任方
Sponsor

研究点 (35)

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