Clinical trial NCT05791916: Novel Biomarkers in Patients With Acute Myocardial Infarction
Official title: Clinical, Laboratory and Echocardiographic Assessment of Biomarkers in Patients With Acute Myocardial Infarction
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cardiovascular Diseases
Myocardial Infarction
Acute Coronary Syndrome
Biochemical Dysfunction
Keywords: Acute Coronary Syndrome
Myocardial Infarction
Echocardiography
Myocardial Work
Biomarkers
Lead sponsor: Aristotle University Of Thessaloniki
Sponsor class: OTHER
First posted: 2023-03-30
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Relationship between clinical, laboratory and echocardiographic biomarkers
timeFrame: 24 months
measure: Relationship between clinical, laboratory, and echocardiographic biomarkers with short- and long-term prognosis of patients
timeFrame: 24 months
Secondary outcomes:
measure: All-cause mortality
timeFrame: 24 months
measure: Cardiovascular mortality
timeFrame: 24 months
measure: Heart Failure hospitalization
timeFrame: 24 months
measure: Acute Coronary syndrome
timeFrame: 24 months
measure: MACE
timeFrame: 24 months
Other outcomes:
Locations:
city: Thessaloníki
country: Greece
facility: AHEPA University Hospital, Thessaloniki, Greece
state: Central Macedonia
city: Thessaloníki
country: Greece
facility: AHEPA University Hospital, Thessaloniki, Greece
state: Central Macedonia
Study officials:
affiliation: School of Medicine, Aristotle University of Thessaloniki
name: Antonios Ziakas, MD, PhD
role: STUDY_DIRECTOR
affiliation: School of Medicine, Aristotle University of Thessaloniki
name: Christos Savopoulos, MD, PhD
role: STUDY_CHAIR
affiliation: School of Medicine, Aristotle University of Thessaloniki
name: Vasileios Kamperidis, MD, MSc, PhD
role: PRINCIPAL_INVESTIGATOR
References: