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临床试验/NCT05791916
NCT05791916招募中不适用

Clinical, Laboratory and Echocardiographic Assessment of Biomarkers in Patients With Acute Myocardial Infarction

Aristotle University Of Thessaloniki1 个研究点 分布在 1 个国家目标入组 500 人开始时间: 2022年3月10日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
500
试验地点
1
主要终点
Relationship between clinical, laboratory, and echocardiographic biomarkers with short- and long-term prognosis of patients

研究概览

简要总结

This study seeks to investigate the clinical value of novel biomarkers and echocardiographic indices, including myocardial work parameters, in patients with first acute myocardial infarction. The relationship between novel echocardiographic indices with clinical data, biochemical data in different myocardial infarction types will be attempted. Prognostic implications of those indices will be explored.

详细描述

This study is a prospective registry designed to evaluate and explore novel associations and prognostic tools in patients with first Acute Myocardial Infarction (AMI) with or without ST elevation, as defined by the Fourth Universal Definition of Myocardial Infarction. All eligible adult patients admitted to the Department of Cardiology at AHEPA University General Hospital of Thessaloniki with AMI will be invited to participate.

Following revascularization, a complete and comprehensive medical interview will be conducted for each patient, during which demographic characteristics, baseline medical history, medical therapy upon admission and discharge, primary aetiology, and clinical presentation of hospitalization will be recorded. Laboratory data will be collected on admission and during hospitalization, including complete blood count, biochemical control, coagulation mechanism control, hormonal control, lipid profile including Lp(a), HbA1c, N-terminal pro-B-type natriuretic peptide plasma, higher-peak value of HsTnT, IL-6, and suPAR levels on admission.

A comprehensive transthoracic echocardiographic assessment (TTE) will be performed within 24-48 hours from revascularization to evaluate the cardiac function of patients. The TTE will include 2-dimensional-speckle-tracking analysis of all cardiac chambers and non-invasive calculation of myocardial work of the left and right ventricles. The clinical value and prognostic implications of these echocardiographic indices will also be investigated during follow-up.

The primary objective is to identify novel prognostic tools by examining the association between echocardiographic indices, clinical, and biochemical data. The study aims to contribute to a better understanding of the pathophysiology of this condition and the development of effective management strategies. By comprehensively assessing the clinical, biochemical, and echocardiographic features of patients with AMI, this study will help to establish a foundation for developing targeted and effective treatments for AMI patients.

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 older than 18 years
  • Patients acutely admitted at the Department of Cardiology of AHEPA University General Hospital, Thessaloniki, Greece with Acute Myocardial Infarction, as those are defined by the Fourth Universal Definition of Myocardial Infarction.
  • Patients without known history of coronary artery disease

排除标准

  • Patients < 18 years old at time of coronary angiography
  • Patients with a previous history of coronary artery disease and/or prior revascularization
  • Inability or refusal to provide informed consent
  • Subject is pregnant and/or breastfeeding or intends to become pregnant during the study

结局指标

主要结局

Relationship between clinical, laboratory, and echocardiographic biomarkers with short- and long-term prognosis of patients

时间窗: 24 months

Clinical, laboratory, and echocardiographic parameters including among others left ventricular myocardial work indices, right ventricular myocardial work indices, 2-dimensional speckle-tracking analysis of all cardiac chambers. Different units of measure in this outcome do not represent different outcome measures. All clinical, laboratory and echocardiographic measurements will be evaluated separately in their own unit of measurement to assess potential prognostic biomarkers in patients with acute myocardial infarction. This does not render the measurement of each parameter a different clinical outcome.

Relationship between clinical, laboratory and echocardiographic biomarkers

时间窗: 24 months

Clinical, laboratory, conventional and novel echocardiographic parameters including among others left ventricular myocardial work indices, right ventricular myocardial work indices, 2-dimensional speckle-tracking analysis of all cardiac chambers.

次要结局

  • Acute Coronary syndrome(24 months)
  • All-cause mortality(24 months)
  • Cardiovascular mortality(24 months)
  • Heart Failure hospitalization(24 months)
  • MACE(24 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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