Clinical trial NCT06753591: PRemature Acute Myocardial Infarction Register of Serbia
Official title: Clinical Characteristics and Outcomes of Patients with Premature Acute Myocardial Infarction in Serbia - a Multicenter National Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Acute Coronary Syndromes
Keywords: Acute Myocardial Infarction
Premature
Young Adults
National Registry
Lead sponsor: Cardiology Society of Serbia
Sponsor class: OTHER
First posted: 2024-12-31
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
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

Brief 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Incidence and Prevalence of AMI in Patients Aged ≤ 45 Years in Serbia
timeFrame: From 01.January 2021.year to 31.December 2026.
measure: Demographic Characteristics and Prevalence of Atherosclerotic Risk Factors in Young AMI Patients
timeFrame: From 01.January 2021.year to 31.December 2026.
measure: Angiographic Characteristics in Young AMI Patients
timeFrame: From 01.January 2021.year to 31.December 2026.
Secondary outcomes:
measure: Characteristics of Atherosclerotic Plaque Using OCT or IVUS
timeFrame: From 01.January 2021.year to 31.December 2026.
measure: Prevalence of SCAD in Young AMI Patients
timeFrame: From 01.January 2021.year to 31.December 2026.
measure: Prevalence of Comorbidities in Young AMI Patients
timeFrame: From 01.January 2021.year to 31.December 2026.
measure: Prevalence of Inherited or Acquired Thrombophilia in MINOCA Patients
timeFrame: From 01.January 2021.year to 31.December 2026.
measure: Prevalence of Familial Hypercholesterolemia in Young AMI Patients
timeFrame: From 01.January 2021.year to 31.December 2026.
measure: Mean Homocysteine Levels in Young AMI Patients
timeFrame: From 01.January 2021.year to 31.December 2026.
measure: Treatment Modalities and Interventions in Young AMI Patients
timeFrame: From 01.January 2021.year to 31.December 2026.
measure: Number of Participants Experiencing MACE During Hospitalization, at 1 Month, and 1 Year Post-AMI
timeFrame: From 01.January 2021.year to 31.December 2026.
Other outcomes:
Locations:
city: Belgrade
country: Serbia
facility: Military Medical Academy 1
city: Belgrade
country: Serbia
facility: University Hospital Center Zvezdara
city: Belgrade
country: Serbia
facility: University Hospital Center Bezanijska kosa
city: Belgrade
country: Serbia
facility: University Hospital Center Zemun
city: Belgrade
country: Serbia
facility: Military Medical Academy 2
city: Kraljevo
country: Serbia
facility: General Hospital Studenica
city: Nis
country: Serbia
facility: University Clinical Center Nis
city: Novi Sad
country: Serbia
facility: Institute for cardiovascular diseases Vojvodina
city: Prokuplje
country: Serbia
facility: General Hospital Prokuplje
city: Vrbas
country: Serbia
facility: General Hospital Vrbas
city: Zrenjanin
country: Serbia
facility: General Hospital Zrenjanin
Study officials:
affiliation: Cardiology Society of Serbia, Belgrade, Serbia
name: Aleksandra Djokovic, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Cardiology Society of Serbia, Belgrade, Serbia
name: Svetlana Apostolovic, Md, PhD
role: PRINCIPAL_INVESTIGATOR
References: