PRemature Acute Myocardial Infarction Register of Serbia

NCT06753591 | Recruiting DMC

• 1 other identifier: 01/2024
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 11

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.

Conditions

Acute Coronary Syndromes

Keywords

Acute Myocardial Infarction; Premature; Young Adults; National Registry

Outcome Measures

Primary Outcomes (3)

• Incidence and Prevalence of AMI in Patients Aged ≤ 45 Years in Serbia

  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

  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

  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 Outcomes (8)

• Characteristics of Atherosclerotic Plaque Using OCT or IVUS

  From 01.January 2021.year to 31.December 2026.

• Prevalence of SCAD in Young AMI Patients

  From 01.January 2021.year to 31.December 2026.

• Prevalence of Comorbidities in Young AMI Patients

  From 01.January 2021.year to 31.December 2026.

• Prevalence of Inherited or Acquired Thrombophilia in MINOCA Patients

  From 01.January 2021.year to 31.December 2026.

• Prevalence of Familial Hypercholesterolemia in Young AMI Patients

  From 01.January 2021.year to 31.December 2026.

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• 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

You may qualify if:

• 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.

You may not qualify if:

• Patients aged \> 45 years.

Sponsors & Collaborators

• Cardiology Society of Serbia: lead

Study Sites (11)

Military Medical Academy 1

Belgrade, 11000, Serbia

RECRUITING

University Hospital Center Zvezdara

Belgrade, 11000, Serbia

RECRUITING

University Hospital Center Bezanijska kosa

Belgrade, 11080, Serbia

RECRUITING

University Hospital Center Zemun

Belgrade, 11080, Serbia

RECRUITING

Military Medical Academy 2

Belgrade, Serbia

RECRUITING

General Hospital Studenica

Kraljevo, 36000, Serbia

RECRUITING

University Clinical Center Nis

Niš, 18000, Serbia

RECRUITING

Institute for cardiovascular diseases Vojvodina

Novi Sad, 21000, Serbia

RECRUITING

General Hospital Prokuplje

Prokuplje, 18400, Serbia

RECRUITING

General Hospital Vrbas

Vrbas, 21460, Serbia

RECRUITING

General Hospital Zrenjanin

Zrenjanin, 23000, Serbia

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Frozen samples for the potential substudies on genetics and non-standard laboratory analysis

MeSH Terms

Conditions

Acute Coronary Syndrome; Premature Birth

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Aleksandra Djokovic, MD, PhD

  Cardiology Society of Serbia, Belgrade, Serbia

  PRINCIPAL INVESTIGATOR

• Svetlana Apostolovic, Md, PhD

  Cardiology Society of Serbia, Belgrade, Serbia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Aleksandra Djokovic, MD, PhD

CONTACT

+381641404922; drsaska@yahoo.com

Svetlana Apostolovic, MD, PhD

CONTACT

+381631094144; drapostolovic@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 18, 2024
• First Posted: December 31, 2024
• Study Start: September 25, 2024
• Primary Completion (Estimated): September 25, 2026
• Study Completion (Estimated): September 25, 2026
• Last Updated: December 31, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: From 30.December 2026
• Access Criteria: Principal Investigators of other national registries involving AIM in young adults

Locations

SE (11)