PRemature Acute Myocardial Infarction Register of Serbia

Last updated: December 30, 2024
Sponsor: Cardiology Society of Serbia
Overall Status: Active - Recruiting

Phase

N/A

Condition

Cardiovascular Disease

Congestive Heart Failure

Hypercholesterolemia

Treatment

N/A

Clinical Study ID

NCT06753591
01/2024
  • Ages 18-45
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

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

Exclusion Criteria:

Patients aged > 45 years.

Study Design

Total Participants: 1000
Study Start date:
September 25, 2024
Estimated Completion Date:
September 25, 2026

Study Description

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.

Connect with a study center

  • Military Medical Academy 1

    Belgrade, 11000
    Serbia

    Active - Recruiting

  • Military Medical Academy 2

    Belgrade,
    Serbia

    Active - Recruiting

  • University Hospital Center Bezanijska kosa

    Belgrade, 11080
    Serbia

    Active - Recruiting

  • University Hospital Center Zemun

    Belgrade, 11080
    Serbia

    Active - Recruiting

  • University Hospital Center Zvezdara

    Belgrade, 11000
    Serbia

    Active - Recruiting

  • General Hospital Studenica

    Kraljevo, 36000
    Serbia

    Active - Recruiting

  • University Clinical Center Nis

    Nis, 18000
    Serbia

    Active - Recruiting

  • Institute for cardiovascular diseases Vojvodina

    Novi Sad, 21000
    Serbia

    Active - Recruiting

  • General Hospital Prokuplje

    Prokuplje, 18400
    Serbia

    Active - Recruiting

  • General Hospital Vrbas

    Vrbas, 21460
    Serbia

    Active - Recruiting

  • General Hospital Zrenjanin

    Zrenjanin, 23000
    Serbia

    Active - Recruiting

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