Novel Biomarkers in Patients With Acute Myocardial Infarction (CLEAR-AMI)

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

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.

Study Overview

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

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 Type: Observational
• Enrollment (Estimated): 500

Contacts and Locations

• Study Contact: Name: Christos Savopoulos, MD, PhD; Phone Number: +30 6944569749; Email: chrisavopoulos@gmail.com

Study Locations

• Greece
  • Central Macedonia
    • Thessaloníki, Central Macedonia, Greece, 54621
      • Recruiting
      • AHEPA University Hospital, Thessaloniki, Greece
      • Contact: Stylianos Daios, MD, MSc; Phone Number: +30§ +306947529606; Email: stylianoschrys.daios@gmail.com
      • Contact: Vasileios Anastasiou, MD, MSc; Phone Number: +30 6978223907; Email: vasianas44@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

This study will enroll consecutive patients admitted to the First Department of Cardiology of AHEPA University General Hospital, Aristotle University of Thessaloniki, Thessaloniki, Greece with first Acute Myocardial Infarction with or without ST elevation, as defined by the Fourth Universal Definition of Myocardial Infarction.

Description

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

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Relationship between clinical, laboratory and echocardiographic biomarkers	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.	24 months
Relationship between clinical, laboratory, and echocardiographic biomarkers with short- and long-term prognosis of patients	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.	24 months

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Aristotle University Of Thessaloniki
• Investigators: Study Director: Antonios Ziakas, MD, PhD, School of Medicine, Aristotle University of Thessaloniki; Study Chair: Christos Savopoulos, MD, PhD, School of Medicine, Aristotle University of Thessaloniki; Principal Investigator: Vasileios Kamperidis, MD, MSc, PhD, School of Medicine, Aristotle University of Thessaloniki

Study record dates

Study Major Dates

• Study Start (Actual): March 10, 2022
• Primary Completion (Estimated): December 10, 2024
• Study Completion (Estimated): February 1, 2025

Study Registration Dates

• First Submitted: March 18, 2023
• First Submitted That Met QC Criteria: March 18, 2023
• First Posted (Actual): March 30, 2023

Study Record Updates

• Last Update Posted (Actual): February 28, 2024
• Last Update Submitted That Met QC Criteria: February 25, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Biomarkers; Echocardiography; Acute Coronary Syndrome; Myocardial Infarction; Myocardial Work
• Additional Relevant MeSH Terms: Ischemia; Pathologic Processes; Necrosis; Myocardial Ischemia; Heart Diseases; Vascular Diseases; Myocardial Infarction; Infarction; Cardiovascular Diseases; Acute Coronary Syndrome
• Other Study ID Numbers: 3456/20

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No