Acute Coronary SyndromesPRAMIRSNCT06753591
PRemature Acute Myocardial Infarction Register of Serbia
An observational study of Acute Coronary Syndromes, run by Cardiology Society of Serbia at 11 sites in Serbia.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Acute Coronary Syndromes
- How many people
- 1,000 participants
- Where
- 11 sitesSerbia
- Study dates
- 25 Sep 2024to 25 Sep 2026
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- No healthy volunteers
- Adult
Study population: This national, multicentric, retrospective and prospective analysis would include patients with acute myocardial infarction (AMI) aged ≤ 45 years in Serbia
Who may be able to join
- 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.
Who cannot join
- Patients aged > 45 years.
Trial locations and contacts
11 sites in 1 country. Contact the study team or a site near you to ask about taking part.
11 sites in 1 country
Serbia11 sites, 11 recruiting
- Recruiting
Military Medical Academy 1
Belgrade, 11000
Jovic Zoran, MD, PhD, +381638051591, zockydr@gmail.com
Zoran Jovic, MD, PhD
- Recruiting
University Hospital Center Zvezdara
Belgrade, 11000
Natasa Markovic Nikolic, MD, PhD, FESC, +38162332641, nmarkovicnikolic@gmail.com
Natasa Markovic Nikolic
- Recruiting
University Hospital Center Bezanijska kosa
Belgrade, 11080
Predrag Djuran, MD, +381646825991, predragdjuran@gmail.com
Slobodan Klasnja, MD, +381641732511, slobodan.klasnja@gmail.com
- Recruiting
University Hospital Center Zemun
Belgrade, 11080
Ivan Stankovic, MD, PhD, +38162403016, future.ivan@gmail.com
Ivan Stankovic, MD, PhD
- Recruiting
Military Medical Academy 2
Belgrade
Nemanja Djenic, MD, PhD, +38163277383, drnemanjadjenic@gmail.com
Nemanja Djenic, MD, PhD
- Recruiting
General Hospital Studenica
Kraljevo, 36000
Tatjana Eric Bradic, MD, +381637151304, kristinabradic1@gmail.com
Tatjana Eric Bradic, MD
- Recruiting
University Clinical Center Nis
Niš, 18000
Svetlana Apostolovic, MD, PhD, FESC, +381631094144, drapostolovic@gmail.com
Svetlana Apostolovic, MD, PhD, FESC
- Recruiting
Institute for cardiovascular diseases Vojvodina
Novi Sad, 21000
Milovan Petrovic, MD, PhD, FESC, +381641153076, petrovici@hotmail.com
Milovan Petrovic, MD, PhD, FESC
- Recruiting
General Hospital Prokuplje
Prokuplje, 18400
Snezana Djokic Milojevic, MD, +381646158004, drnenapk@yahoo.com
Snezana Djokic Milojevic, MD
- Recruiting
General Hospital Vrbas
Vrbas, 21460
Vujadin Trivkovic, MD, +381641909384, trivkovicvujadin@gmail.com
Vujadin Trivkovic, MD
- Recruiting
General Hospital Zrenjanin
Zrenjanin, 23000
Jelena Lukic Petrov, MD, +381, jelena.lukicpetrov@gmail.com
Jelena Lukic Petrov, MD
About this study
Official title: 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.
Read more
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.
Read the 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
- Keywords
- Acute Myocardial Infarction, Premature, Young Adults, National Registry
- Medical subject headings
- Acute Coronary Syndrome, Premature Birth
What is being measured
The primary outcome is the main question the study is designed to answer.
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."
Measured: 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."
Measured: 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."
Measured: From 01.January 2021.year to 31.December 2026.
Secondary outcomes (8)
Characteristics of Atherosclerotic Plaque Using OCT or IVUS
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)."
Measured: From 01.January 2021.year to 31.December 2026.
Prevalence of SCAD in Young AMI Patients
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."
Measured: From 01.January 2021.year to 31.December 2026.
Prevalence of Comorbidities in Young AMI Patients
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."
Measured: From 01.January 2021.year to 31.December 2026.
Prevalence of Inherited or Acquired Thrombophilia in MINOCA Patients
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."
Measured: From 01.January 2021.year to 31.December 2026.
Prevalence of Familial Hypercholesterolemia in Young AMI Patients
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."
Measured: From 01.January 2021.year to 31.December 2026.
Mean Homocysteine Levels in Young AMI Patients
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)."
Measured: From 01.January 2021.year to 31.December 2026.
Treatment Modalities and Interventions in Young AMI Patients
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."
Measured: From 01.January 2021.year to 31.December 2026.
Number of Participants Experiencing MACE During Hospitalization, at 1 Month, and 1 Year Post-AMI
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."
Measured: From 01.January 2021.year to 31.December 2026.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2024
- Study start25 Sep 2024
- Primary completion25 Sep 2026 (estimated)
- Study completion25 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Coronary SyndromesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 1,000 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Cardiology Society of Serbia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Aleksandra Djokovic, MD, PhD, Principal investigator, Cardiology Society of Serbia, Belgrade, SerbiaSvetlana Apostolovic, Md, PhD, Principal investigator, Cardiology Society of Serbia, Belgrade, Serbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06753591
- Sponsor's protocol ID
- 01/2024
- Acronym
- PRAMIRS
- Status last verified
- Dec 2024
- First submitted
- 18 Dec 2024
- Last updated
- 31 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: For the purposes of meta statistical analysis
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Characteristics and Outcomes of Patients with Premature Acute Myocardial Infarction in Serbia - a Multicenter National Study
- ClinicalTrials.gov ID
- NCT06753591
- Acronym / sponsor ID
- PRAMIRS / 01/2024
- Conditions
- Acute Coronary Syndromes
- Keywords
- Acute Myocardial Infarction, Premature, Young Adults, National Registry
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Cardiology Society of SerbiaUniversity, hospital or other
- Study start
- 25 Sep 2024 (actual)
- Primary completion
- 25 Sep 2026 (estimated)
- Study completion
- 25 Sep 2026 (estimated)
- First posted
- 31 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 1 Year
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- This national, multicentric, retrospective and prospective analysis would include patients with acute myocardial infarction (AMI) aged ≤ 45 years in Serbia
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (1 listed)
- Patients aged > 45 years.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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."
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."
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."
8 secondary outcomes
Characteristics of Atherosclerotic Plaque Using OCT or IVUS
Time frame: 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.
Prevalence of Comorbidities in Young AMI Patients
Time frame: 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.
Prevalence of Familial Hypercholesterolemia in Young AMI Patients
Time frame: 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.
Treatment Modalities and Interventions in Young AMI Patients
Time frame: 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Dec 2024.
- Individual participant dataSharing planned: Yes. For the purposes of meta statistical analysis
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Aleksandra Djokovic, MD, PhD principal investigator
Cardiology Society of Serbia, Belgrade, Serbia
Svetlana Apostolovic, Md, PhD principal investigator
Cardiology Society of Serbia, Belgrade, Serbia
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Coronary Syndromes, run by Cardiology Society of Serbia at 11 sites in Serbia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 31 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in Serbia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Aleksandra Djokovic, MD, PhD (+381641404922, drsaska@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence and Prevalence of AMI in Patients Aged ≤ 45 Years in Serbia (time frame: From 01.January 2021.year to 31.December 2026.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Dec 2024.