Novel Biomarkers in Patients With Acute Myocardial Infarction

Recruiting

• Conditions: Cardiovascular Diseases; Myocardial Infarction; Biochemical Dysfunction; Acute Coronary Syndrome

• Registration Number: NCT05791916
• Lead Sponsor: Aristotle University Of Thessaloniki

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2022-03-10
• Study First Submitted: 2023-03-18
• Study First Submitted QC: 2023-03-18
• Study First Posted: 2023-03-30
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-25
• Last Update Posted: 2024-02-28
• Primary Completion: 2024-12-10
• Study Completion: 2025-02

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 500

Inclusion Criteria

1. Patients older than 18 years
2. 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.
3. Patients without known history of coronary artery disease

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Exclusion Criteria

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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
All-cause mortality	24 months	Death by any cause
Cardiovascular mortality	24 months	Death directly attributed to the primary disease
Heart Failure hospitalization	24 months	Hospitalization due to heart failure
Acute Coronary syndrome	24 months	Acute Coronary Syndrome including Myocardial Infarction with or without ST elevation and Unstable Angina
MACE	24 months	Composite of all-cause mortality, non-fatal acute coronary syndrome and heart failure hospitalization

Trial Locations

Locations (1)

AHEPA University Hospital, Thessaloniki, Greece; 🇬🇷 Thessaloníki, Central Macedonia, Greece