PRemature Acute Myocardial Infarction Register of Serbia (PRAMIRS)

December 30, 2024 updated by: Cardiology Society of Serbia

Clinical Characteristics and Outcomes of Patients with Premature Acute Myocardial Infarction in Serbia - a Multicenter National Study

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.

Study Overview

Status

Recruiting

Conditions

Detailed 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.

Study Type

Observational

Enrollment (Estimated)

1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Aleksandra Djokovic, MD, PhD
  • Phone Number: +381641404922
  • Email: drsaska@yahoo.com

Study Contact Backup

Study Locations

  • Serbia
      • Belgrade, Serbia, 11000
        • Recruiting
        • Military Medical Academy 1
        • Contact:
        • Contact:
          • Zoran Jovic, MD, PhD
        • Contact:
          • Ivica Djuric, MD
        • Contact:
          • Miljan Opancina, MD, PhD
        • Contact:
          • Stefan Milenovic, MD, PhD
      • Belgrade, Serbia, 11000
        • Recruiting
        • University Hospital Center Zvezdara
        • Contact:
        • Contact:
          • Natasa Markovic Nikolic
        • Contact:
          • Miroslav Martinovic, MD
        • Contact:
          • Luka Dodic, MD
      • Belgrade, Serbia, 11080
        • Recruiting
        • University Hospital Center Bezanijska kosa
        • Contact:
        • Contact:
        • Contact:
          • Aleksandra Djokovic, MD, PhD, FESC
        • Contact:
          • Predrag Djuran, MD
        • Contact:
          • Slobodan Klasnja, MD
        • Contact:
          • Marija Zdravkovic, MD, PhD, FESC
        • Contact:
          • Branislava Todic, MD
        • Contact:
          • Viseslav Popadic, MD
        • Contact:
          • Jelena Saric, MD
        • Contact:
          • Tatjana Bojicic, MD
        • Contact:
          • Amra Ljajic, MD
      • Belgrade, Serbia, 11080
        • Recruiting
        • University Hospital Center Zemun
        • Contact:
        • Contact:
          • Ivan Stankovic, MD, PhD
        • Contact:
          • Sofija Neskovic, MD
      • Belgrade, Serbia
        • Recruiting
        • Military Medical Academy 2
        • Contact:
        • Contact:
          • Nemanja Djenic, MD, PhD
        • Contact:
          • Milena Miletic, MD, PhD
        • Contact:
          • Jovan Dzepina, MD
        • Contact:
          • Valentino Vurdelja, MD
        • Contact:
          • Marko Milosevic, MD
      • Kraljevo, Serbia, 36000
        • Recruiting
        • General Hospital Studenica
        • Contact:
        • Contact:
          • Tatjana Eric Bradic, MD
        • Contact:
          • Aleksandra Koricanac, MD
        • Contact:
          • Dragana Mirkovic, MD
      • Nis, Serbia, 18000
        • Recruiting
        • University Clinical Center Nis
        • Contact:
        • Contact:
          • Svetlana Apostolovic, MD, PhD, FESC
        • Contact:
          • Danijela Djordjevic Radojkovic, MD
        • Contact:
          • Sonja Dakic, MD
        • Contact:
          • Bojan Maricic, MD
        • Contact:
          • Tamara Filipovic, MD
      • Novi Sad, Serbia, 21000
        • Recruiting
        • Institute for cardiovascular diseases Vojvodina
        • Contact:
        • Contact:
          • Milovan Petrovic, MD, PhD, FESC
      • Prokuplje, Serbia, 18400
        • Recruiting
        • General Hospital Prokuplje
        • Contact:
        • Contact:
          • Snezana Djokic Milojevic, MD
        • Contact:
          • Marija Miljkovic, MD
      • Vrbas, Serbia, 21460
        • Recruiting
        • General Hospital Vrbas
        • Contact:
        • Contact:
          • Vujadin Trivkovic, MD
      • Zrenjanin, Serbia, 23000
        • Recruiting
        • General Hospital Zrenjanin
        • Contact:
        • Contact:
          • Jelena Lukic Petrov, MD
        • Contact:
          • Uros Bacic, MD
        • Contact:
          • Teodora Paunic Bugar, MD
        • Contact:
          • Velimir Colak, MD
        • Contact:
          • Doru Orza, MD
        • Contact:
          • Blagoje Kovacevic
        • Contact:
          • Luka Sentivanski, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

This national, multicentric, retrospective and prospective analysis would include patients with acute myocardial infarction (AMI) aged ≤ 45 years in Serbia

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence and Prevalence of AMI in Patients Aged ≤ 45 Years in Serbia
Time Frame: From 01.January 2021.year to 31.December 2026.
The incidence and prevalence of AMI among patients aged ≤ 45 years in Serbia will be reported over the study period, expressed as the number of new and existing cases per 100,000 individuals annually Unit of Measure: "Cases per 100,000 individuals per year."
From 01.January 2021.year to 31.December 2026.
Demographic Characteristics and Prevalence of Atherosclerotic Risk Factors in Young AMI Patients
Time Frame: From 01.January 2021.year to 31.December 2026.

The demographic distribution (e.g., age, gender, socioeconomic status) and prevalence of standard atherosclerotic risk factors (e.g., smoking, diabetes, hypertension, hyperlipidemia) among AMI patients aged ≤ 45 years will be analyzed.

Unit of Measure: "Percent of participants with each risk factor."
From 01.January 2021.year to 31.December 2026.
Angiographic Characteristics in Young AMI Patients
Time Frame: From 01.January 2021.year to 31.December 2026.

The presence and extent of obstructive and non-obstructive coronary artery disease, coronary lesions, dissection, and vasospasm will be assessed using angiographic findings.

Unit of Measure: "Percent of participants with each angiographic characteristic."
From 01.January 2021.year to 31.December 2026.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Characteristics of Atherosclerotic Plaque Using OCT or IVUS
Time Frame: From 01.January 2021.year to 31.December 2026.

Plaque characteristics, including degree of fibrosis, necrosis, calcification, and vulnerability, will be evaluated in a subset of patients using OCT or IVUS imaging.

Unit of Measure: "Percent of plaques with specific characteristics (e.g., fibrosis, calcification)."
From 01.January 2021.year to 31.December 2026.
Prevalence of SCAD in Young AMI Patients
Time Frame: From 01.January 2021.year to 31.December 2026.

The prevalence of SCAD, including angiographic subtypes defined by current guidelines, will be assessed among participants.

Unit of Measure: "Percent of participants diagnosed with SCAD."
From 01.January 2021.year to 31.December 2026.
Prevalence of Comorbidities in Young AMI Patients
Time Frame: From 01.January 2021.year to 31.December 2026.

The prevalence of comorbid conditions such as kidney disease, chronic lung diseases, systemic autoimmune diseases, and specific chronic therapies will be assessed.

Unit of Measure: "Percent of participants with each comorbidity."
From 01.January 2021.year to 31.December 2026.
Prevalence of Inherited or Acquired Thrombophilia in MINOCA Patients
Time Frame: From 01.January 2021.year to 31.December 2026.

The presence of inherited or acquired thrombophilia in patients with myocardial infarction with non-obstructive coronary arteries (MINOCA) will be analyzed using genetic and laboratory tests.

Unit of Measure: "Percent of MINOCA participants with thrombophilia."
From 01.January 2021.year to 31.December 2026.
Prevalence of Familial Hypercholesterolemia in Young AMI Patients
Time Frame: From 01.January 2021.year to 31.December 2026.

The prevalence of familial hypercholesterolemia in the study population will be determined using genetic testing and clinical diagnostic criteria.

Unit of Measure: "Percent of participants diagnosed with familial hypercholesterolemia."
From 01.January 2021.year to 31.December 2026.
Mean Homocysteine Levels in Young AMI Patients
Time Frame: From 01.January 2021.year to 31.December 2026.

Homocysteine concentrations will be measured in all participants to determine average levels and their correlation with AMI.

Unit of Measure: "Mean homocysteine concentration (µmol/L)."
From 01.January 2021.year to 31.December 2026.
Treatment Modalities and Interventions in Young AMI Patients
Time Frame: From 01.January 2021.year to 31.December 2026.

The number and type of percutaneous coronary interventions (PCI), number of stents implanted, and antiplatelet/anticoagulant therapies will be assessed.

Unit of Measure: "Percent of participants receiving specific interventions."
From 01.January 2021.year to 31.December 2026.
Number of Participants Experiencing MACE During Hospitalization, at 1 Month, and 1 Year Post-AMI
Time Frame: From 01.January 2021.year to 31.December 2026.

The number of participants experiencing MACE, including cardiovascular death, recurrent MI, revascularization, stroke, heart failure, or hospitalization, will be recorded during hospitalization at 1-month and 1-year follow-ups.

Unit of Measure: "Number of participants experiencing MACE."
From 01.January 2021.year to 31.December 2026.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cardiology Society of Serbia

Investigators

  • Principal Investigator: Aleksandra Djokovic, MD, PhD, Cardiology Society of Serbia, Belgrade, Serbia
  • Principal Investigator: Svetlana Apostolovic, Md, PhD, Cardiology Society of Serbia, Belgrade, Serbia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 25, 2024

Primary Completion (Estimated)

September 25, 2026

Study Completion (Estimated)

September 25, 2026

Study Registration Dates

First Submitted

December 18, 2024

First Submitted That Met QC Criteria

December 30, 2024

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

December 30, 2024

Last Verified

December 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 01/2024

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

For the purposes of meta statistical analysis

IPD Sharing Time Frame

From 30.December 2026

IPD Sharing Access Criteria

Principal Investigators of other national registries involving AIM in young adults

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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