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临床试验/NCT07086807
NCT07086807已完成不适用

Predictors and Impact of Total Occlusion of the Infarct-Related Coronary Artery on Short-Term Mortality in Patients With Acute Myocardial Infarction

University Hospital Sestre Milosrdnice0 个研究点目标入组 2,000 人开始时间: 2011年1月1日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
2,000
主要终点
Mortality

研究概览

简要总结

Aim of this study is to determine the prevalence, predictors, and impact of total occlusion of the infarct-related coronary artery (IRA) on short-term mortality.

详细描述

We will conduct a prospective, single-center cohort study based on a clinical registry that will include consecutive patients treated for acute myocardial infarction (AMI) with percutaneous coronary intervention (PCI) at the University Hospital Centre Sestre milosrdnice, Zagreb, Croatia, between 2011 and 2018. All patients will receive treatment in accordance with the European Society of Cardiology (ESC) guidelines current at the time. Revascularization will be performed by five experienced interventional cardiologists, each with over five years of experience and performing more than 150 PCI procedures annually. The identification of the culprit lesion will be left to the discretion of the operating physician.

Patients will be excluded if they are treated without PCI, are diagnosed with myocardial infarction with non-obstructive coronary arteries (MINOCA), or undergo surgical revascularization (coronary artery bypass grafting).

Data will be collected from the hospital electronic medical records and patient charts. Mortality data will be obtained from the Croatian National Institute of Public Health cause-of-death registry. Collected variables will include baseline demographic data, medical history, chronic pre-admission pharmacotherapy, in-hospital course, complications, and procedural characteristics. All angiograms will be re-evaluated independently by two experienced interventional cardiologists. Chronic pharmacotherapy will be considered relevant if the patient has been taking the medication for at least four weeks prior to the index event. Significant carotid artery stenosis will be defined as a luminal narrowing of more than 50%.

Patients will be divided into two groups based on the patency of the infarct-related artery (IRA): those with an occluded coronary artery (OCA group) and those with a patent coronary artery (PCA group). A patent artery will be defined as having visible antegrade flow of at least TIMI grade I distal to the culprit lesion. Occlusion will be defined as complete absence of antegrade flow beyond the site of the lesion (TIMI 0), with no visible antegrade or retrograde collateral circulation. All the patients will be pretreated with 300 mg of acetylsalicylic acid and 600 mg of clopidogrel or 180 mg of ticagrelor, depending on current guidelines.

All patients will be followed until the primary endpoint is reached or for 30 days from the index hospitalization. The primary clinical endpoint will be all-cause mortality during the follow-up period.

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

入选标准

  • patients treated with PCI for AMI

排除标准

  • treated without PCI,
  • diagnosed with myocardial infarction with non-obstructive coronary arteries (MINOCA),
  • underwent surgical revascularization (coronary artery bypass grafting).

结局指标

主要结局

Mortality

时间窗: 12 months

Death due to all reasons in a period od 12 months after myocardial infartion

次要结局

未报告次要终点

研究者

发起方
University Hospital Sestre Milosrdnice
申办方类型
Other
责任方
Principal Investigator
主要研究者

Nikola Kos

MD, PhD, cardiologist

University Hospital Sestre Milosrdnice

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