PRemature Acute Myocardial Infarction Register of Serbia

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

1000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-09-25

Study Completion Date

2026-09-25

Brief Summary

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This observational multicentric national study aims to understand better acute myocardial infarction (heart attack) in young adults aged 45 years or younger in Serbia. By analyzing patient characteristics, medical history, test results, and treatment outcomes, the research seeks to identify factors contributing to heart attacks in this population and improve prevention and treatment strategies.

Participants will undergo routine tests during hospitalization, and specific blood samples will be collected for advanced analyses, including genetic testing. Follow-up will include periodic check-ins to monitor health outcomes.

The study will also explore differences in heart attack causes and outcomes in younger individuals compared to older populations, focusing on risk factors like smoking, cholesterol levels, and genetic predisposition.

Participation is voluntary, and all collected data will remain confidential.

Detailed Description

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Study Overview This national, multicenter study combines retrospective and prospective analyses to investigate AMI in patients aged ≤ 45 years in Serbia. The primary aim is to characterize the clinical, demographic, and angiographic profiles of these patients, identify specific risk factors, and evaluate treatment outcomes. The findings aim to inform prevention, early diagnosis, and treatment strategies for premature AMI.

Objectives

Primary Objectives:

Determine the incidence and prevalence of AMI in this population. Analyze demographic characteristics and the prevalence of standard atherosclerotic risk factors (e.g., smoking, diabetes, hypertension, and socioeconomic status).

Examine angiographic findings, including obstructive or non-obstructive coronary artery disease and other abnormalities.

Secondary Objectives:

Assess atherosclerotic plaque characteristics using OCT or IVUS imaging. Evaluate the prevalence of spontaneous coronary artery dissection (SCAD) and comorbid conditions like chronic kidney disease and autoimmune diseases.

Investigate genetic predispositions (e.g., thrombophilia, familial hypercholesterolemia) and metabolic markers like homocysteine.

Monitor treatment outcomes, including major adverse cardiovascular events (MACE) during hospitalization and at follow-ups.

Design and Methodology

The study adheres to the Universal Definition of Myocardial Infarction and includes detailed data collection:

Demographics: age, gender, socioeconomic status, and rural vs. urban residency. Clinical Data: chest pain characteristics, ECG findings, and laboratory markers like lipids, homocysteine, and inflammatory markers.

Imaging and Diagnostics: echocardiography, angiography, OCT/IVUS imaging, and cardiac MRI for MINOCA cases.

Therapeutics: Analysis of treatment methods, including interventions, antiplatelet agents, and anticoagulants.

Study Population

Inclusion Criteria: Patients aged ≤ 45 years diagnosed with AMI who provide informed consent.

Exclusion Criteria: Patients aged \> 45 years. Sample Size and Data Analysis Approximately 200 participants will be enrolled annually, with a target of 1,000 participants over five years. Data will be analyzed using statistical methods to identify predictors of adverse outcomes and evaluate survival rates.

Ethical Considerations This study complies with ethical standards and protects patient rights and data confidentiality. Participation is voluntary, and patients may withdraw at any time without affecting their care.

Significance The study aims to close a critical knowledge gap regarding premature AMI, contributing to improved prevention and management strategies in young adults at the national level.

Conditions

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Acute Coronary Syndromes

Keywords

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Acute Myocardial Infarction Premature Young Adults National Registry

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

Eligibility Criteria

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Inclusion Criteria

Patients aged ≤ 45 years. Clinical and laboratory diagnosis of acute myocardial infarction (AMI) based on the Universal Definition of Myocardial Infarction.

Voluntary participation with signed informed consent.

Exclusion Criteria

Patients aged \> 45 years.

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Aleksandra Djokovic, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Cardiology Society of Serbia, Belgrade, Serbia

Svetlana Apostolovic, Md, PhD

Role: PRINCIPAL_INVESTIGATOR

Cardiology Society of Serbia, Belgrade, Serbia

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Serbia

Central Contacts

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Aleksandra Djokovic, MD, PhD

Role: CONTACT

Phone: +381641404922

Role: backup

Luka Sentivanski, MD

Role: backup

Other Identifiers

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01/2024

Identifier Type: -

Identifier Source: org_study_id

PRemature Acute Myocardial Infarction Register of Serbia

Study Results

Basic Information

Brief Summary

Detailed Description

Conditions

Keywords

Study Design

Eligibility Criteria

Inclusion Criteria

Exclusion Criteria

Sponsors

Cardiology Society of Serbia

Responsible Party

Principal Investigators

Aleksandra Djokovic, MD, PhD

Svetlana Apostolovic, Md, PhD

Locations

Military Medical Academy 1

University Hospital Center Zvezdara

University Hospital Center Bezanijska kosa

University Hospital Center Zemun

Military Medical Academy 2

General Hospital Studenica

University Clinical Center Nis

Institute for cardiovascular diseases Vojvodina

General Hospital Prokuplje

General Hospital Vrbas

General Hospital Zrenjanin

Countries

Central Contacts

Aleksandra Djokovic, MD, PhD

Svetlana Apostolovic, MD, PhD

Facility Contacts

Jovic Zoran, MD, PhD

Zoran Jovic, MD, PhD

Ivica Djuric, MD

Miljan Opancina, MD, PhD

Stefan Milenovic, MD, PhD

Natasa Markovic Nikolic, MD, PhD, FESC

Natasa Markovic Nikolic

Miroslav Martinovic, MD

Luka Dodic, MD

Predrag Djuran, MD

Slobodan Klasnja, MD

Aleksandra Djokovic, MD, PhD, FESC

Predrag Djuran, MD

Slobodan Klasnja, MD

Marija Zdravkovic, MD, PhD, FESC

Branislava Todic, MD

Viseslav Popadic, MD

Jelena Saric, MD

Tatjana Bojicic, MD

Amra Ljajic, MD

Ivan Stankovic, MD, PhD

Ivan Stankovic, MD, PhD

Sofija Neskovic, MD

Nemanja Djenic, MD, PhD

Nemanja Djenic, MD, PhD

Milena Miletic, MD, PhD

Jovan Dzepina, MD

Valentino Vurdelja, MD

Marko Milosevic, MD

Tatjana Eric Bradic, MD

Tatjana Eric Bradic, MD

Aleksandra Koricanac, MD

Dragana Mirkovic, MD

Svetlana Apostolovic, MD, PhD, FESC

Svetlana Apostolovic, MD, PhD, FESC

Danijela Djordjevic Radojkovic, MD

Sonja Dakic, MD

Bojan Maricic, MD

Tamara Filipovic, MD

Milovan Petrovic, MD, PhD, FESC

Milovan Petrovic, MD, PhD, FESC

Snezana Djokic Milojevic, MD

Snezana Djokic Milojevic, MD

Marija Miljkovic, MD

Vujadin Trivkovic, MD

Vujadin Trivkovic, MD