NCT06753591

PRemature Acute Myocardial Infarction Register of Serbia

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 1,000 (estimated)
• Sponsor: Cardiology Society of Serbia · Academic / Other
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Acute Coronary Syndromes

Timeline

• Start date: 2024-09-25
• Primary completion: 2026-09-25
• Completion: 2026-09-25
• First posted: 2024-12-31
• Last updated: 2024-12-31

Locations

11 sites across 1 country: Serbia