Cardiac ComplicationsOHCA_PLNCT06948266
The Study Aims to Investigate the Frequency and Clinical Characteristics of Out-of-hospital Cardiac Arrests (OHCA) Occurring in Poland in 2023. This Research Seeks to Provide a Comprehensive Analysis of OHCA Incidents Across the Country, Focusing on Their Prevalence and the Associated Clinical fe
An observational study of Cardiac Complications and Sudden Cardiac Arrest, run by Medical University of Gdansk at 1 site in Poland.
Trial summary
1. Objective According to the 2021 European Resuscitation Council (ERC) Guidelines, sudden cardiac arrest is the third leading cause of death in Europe. Accurate and reliable data on the epidemiology of sudden cardiac arrest are essential for better understanding its causes and for analyzing treatment outcomes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Complications, Sudden Cardiac Arrest, Cardiac Diseases
- How many people
- 100,000 participants
- Where
- 1 sitePoland
- Study dates
- 1 Jan 2025to Jul 2025
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adults (≥18 years) who experienced an OHCA in 2023, identified through MEPCs
Who may be able to join
- Adults (≥18 years) who experienced an OHCA in 2023, identified through MEPCs containing at least one of the following indicators:
- ICD-10 codes: I46, R98, R96 in the diagnosis section. Witness-reported initiation of CPR in the patient examination section. Indication of cardiac arrest in the symptoms table. Documented rhythms such as VF/VT, asystole, or PEA in the ECG table. Noted interventions like manual/mechanical chest compressions or defibrillation in the patient management table.
- Reasons for cessation of resuscitation efforts in the death/discontinuation table.
Who cannot join
- Individuals under 18 years of age.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Frequency and Clinical Features of Out-of-hospital Cardiac Arrest and Cardiopulmonary Resuscitation in 2023 in Poland - Retrospective Analysis.
- Objective According to the 2021 European Resuscitation Council (ERC) Guidelines, sudden cardiac arrest is the third leading cause of death in Europe. Accurate and reliable data on the epidemiology of sudden cardiac arrest are essential for better understanding its causes and for analyzing treatment outcomes. Currently, comprehensive statistics on cardiac arrest in Poland are unavailable, resulting in limited knowledge about the scale of this medical issue. This study aims to examine the frequency and clinical characteristics of out-of-hospital cardiac arrests occurring nationwide in 2023.
- Materials and Methods The analysis will include Emergency Medical Activity Cards from the year 2023. Data for the study will be obtained from the National Center for Monitoring Emergency Medical Services via the Department of Emergency Medical Services of the Polish Ministry of Health and from the Polish Medical Air Rescue. Data will be anonymized by data administrators before being provided to the research team. The analysis of the obtained results will be supplemented with publicly available data from the Central Statistical Office (GUS). The analyzed Emergency Medical Activity Cards will be evaluated according to the Utstein Out-of-Hospital Cardiac Arrest Registry template from 1991, with subsequent updates, the latest being in 2024, published under the title: "Cardiac arrest and cardiopulmonary resuscitation outcome reports: 2024 update of the Utstein Out-of-Hospital Cardiac Arrest Registry template - ILCOR Scientific Statement."
- Study Population Adults who experienced out-of-hospital cardiac arrest in 2023.
- Inclusion and Exclusion Criteria Exclusion Criteria: Age under 18 years. Inclusion Criteria: Emergency Medical Activity Cards containing at least one of the following criteria: In section IV DIAGNOSIS with ICD-10 codes: I46, R98, R96. In section III EXAMINATION, interview data indicating that bystanders initiated CPR. ResearchGate
- 1 PMC
- 1 In the SYMPTOMS table, marked as cardiac arrest. In the ECG table, marked rhythms: VF/VT, Asystole, PEA. In the PATIENT MANAGEMENT table, marked: MANUAL CHEST COMPRESSIONS, MECHANICAL CHEST COMPRESSIONS, DEFIBRILLATION. In the DEATH-WITHDRAWAL table, information on the reason for discontinuing resuscitation efforts. Only adult patients will be included in the study. Available demographic data will include patient age, gender, and the territorial area of the medical event, indicated by the location of the call and the voivodeship.
Read more
- Estimated Study Group Size 100,000 records.
- Estimated Study Duration
The study is planned for a period of 6 months.
References:
European Resuscitation Council Guidelines 2021.
Gräsner JT, Bray JE, Nolan JP, et al. "Cardiac arrest and cardiopulmonary resuscitation outcome reports: 2024 update of the Utstein Out-of-Hospital Cardiac Arrest Registry template - ILCOR Scientific Statement."
Read the detailed description
Frequency and Clinical Characteristics of Out-of-Hospital Cardiac Arrest in Poland in 2023
Background and Objective
Out-of-hospital cardiac arrest (OHCA) is a major public health concern and, according to the 2021 European Resuscitation Council guidelines, sudden cardiac arrest is the third leading cause of death in Europe cprguidelines.eu
. Despite its significance, Poland lacks a comprehensive national registry for OHCA, and complete nationwide data have not been available. This study is designed to fill that gap by determining the incidence of OHCA in Poland during 2023 and describing the clinical characteristics of these cases.
Methods
Study Design: This is a retrospective observational study analyzing all OHCA events that occurred in Poland in the year 2023. The study will use de-identified patient data drawn from official emergency medical service records. Data Sources: OHCA cases will be identified from the Emergency Medical Procedure Records (Karty Medycznych Czynności Ratunkowych, KMCR) for 2023. These records will be obtained through the National Emergency Medical Services Monitoring Center in collaboration with the Ministry of Health and the Polish Medical Air Rescue. All records will be anonymized by the data providers before being released to the research team to ensure patient confidentiality. In addition, publicly available demographic statistics from Statistics Poland (GUS) will be incorporated to provide context regarding population and regional distribution. Data Analysis: The collected data will be analyzed following the standardized Utstein-style template for reporting cardiac arrest, using the latest 2024 update for out-of-hospital cardiac arrest registries (as recommended by the International Liaison Committee on Resuscitation). This framework will ensure consistent definitions and allow benchmarking against international data. Key variables to be examined include the frequency (incidence) of OHCA, patient demographics (such as age and sex), circumstances of the arrest (e.g. location, whether it was witnessed, initial ECG rhythm), the interventions performed by bystanders and emergency medical services (such as CPR and defibrillation), and patient outcomes (including return of spontaneous circulation and survival to hospital admission). By adhering to the Utstein reporting guidelines, the study's findings will be comparable with other regional and international OHCA data, thereby enhancing their utility for epidemiological insight.
Significance
This study will provide the first comprehensive overview of OHCA occurrences across Poland for an entire year. The results are expected to furnish critical epidemiological data on how often cardiac arrests happen outside of hospitals and what clinical factors characterize these events. Such information is essential for public health authorities and medical professionals to understand current gaps in the chain of survival, to plan targeted interventions, and to improve resuscitation outcomes. Ultimately, the knowledge gained from this nationwide analysis can guide policy and training initiatives aimed at reducing mortality from sudden cardiac arrest.
- Keywords
- sudden cardiac death, poland, OHCA
- Medical subject headings
- Death, Sudden, Cardiac, Heart Diseases, Heart Arrest
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| OHCA | OHCA in Oland in 2023. |
What is being measured
The primary outcome is the main question the study is designed to answer.
OHCA
Number of OHCA in Poland in 2023
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2025
- Study start1 Jan 2025
- Primary completionJun 2025 (estimated)
- Study completionJul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac ComplicationsStudies of the same condition, open and under way.
- More trials run by Medical University of GdanskThe sponsor's other registered studies.
- 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
- Retrospective
- Enrolment
- 100,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Gdansk
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michal Szymanski, Medical University of Gdansk
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06948266
- Sponsor's protocol ID
- OHCA_PL
- Acronym
- OHCA_PL
- Status last verified
- Apr 2025
- First submitted
- 21 Apr 2025
- Last updated
- 29 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Yes, individual participant data (IPD) that underlie the results reported in this study will be made available upon reasonable request. Interested researchers may contact the corresponding author via email to obtain access, contingent upon appropriate data use agreements and ethical approvals.
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Frequency and Clinical Features of Out-of-hospital Cardiac Arrest and Cardiopulmonary Resuscitation in 2023 in Poland - Retrospective Analysis.
- ClinicalTrials.gov ID
- NCT06948266
- Acronym / sponsor ID
- OHCA_PL / OHCA_PL
- Keywords
- sudden cardiac death, poland, OHCA
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 100,000 participants (estimated)
- Lead sponsor
- Medical University of GdanskUniversity, hospital or other
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- Jun 2025 (estimated)
- Study completion
- Jul 2025 (estimated)
- First posted
- 29 Apr 2025 (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.
- Objective According to the 2021 European Resuscitation Council (ERC) Guidelines, sudden cardiac arrest is the third leading cause of death in Europe. Accurate and reliable data on the epidemiology of sudden cardiac arrest are essential for better understanding its causes and for analyzing treatment outcomes. Currently, comprehensive statistics on cardiac arrest in Poland are unavailable, resulting in limited knowledge about the scale of this medical issue. This study aims to examine the frequency and clinical characteristics of out-of-hospital cardiac arrests occurring nationwide in 2023.
- Materials and Methods The analysis will include Emergency Medical Activity Cards from the year 2023. Data for the study will be obtained from the National Center for Monitoring Emergency Medical Services via the Department of Emergency Medical Services of the Polish Ministry of Health and from the Polish Medical Air Rescue. Data will be anonymized by data administrators before being provided to the research team. The analysis of the obtained results will be supplemented with publicly available data from the Central Statistical Office (GUS). The analyzed Emergency Medical Activity Cards will be evaluated according to the Utstein Out-of-Hospital Cardiac Arrest Registry template from 1991, with subsequent updates, the latest being in 2024, published under the title: "Cardiac arrest and cardiopulmonary resuscitation outcome reports: 2024 update of the Utstein Out-of-Hospital Cardiac Arrest Registry template - ILCOR Scientific Statement."
- Study Population Adults who experienced out-of-hospital cardiac arrest in 2023.
- Inclusion and Exclusion Criteria Exclusion Criteria: Age under 18 years. Inclusion Criteria: Emergency Medical Activity Cards containing at least one of the following criteria: In section IV DIAGNOSIS with ICD-10 codes: I46, R98, R96. In section III EXAMINATION, interview data indicating that bystanders initiated CPR. ResearchGate
- 1 PMC
- 1 In the SYMPTOMS table, marked as cardiac arrest. In the ECG table, marked rhythms: VF/VT, Asystole, PEA. In the PATIENT MANAGEMENT table, marked: MANUAL CHEST COMPRESSIONS, MECHANICAL CHEST COMPRESSIONS, DEFIBRILLATION. In the DEATH-WITHDRAWAL table, information on the reason for discontinuing resuscitation efforts. Only adult patients will be included in the study. Available demographic data will include patient age, gender, and the territorial area of the medical event, indicated by the location of the call and the voivodeship.
- Estimated Study Group Size 100,000 records.
- Estimated Study Duration
The study is planned for a period of 6 months.
References:
European Resuscitation Council Guidelines 2021.
Gräsner JT, Bray JE, Nolan JP, et al. "Cardiac arrest and cardiopulmonary resuscitation outcome reports: 2024 update of the Utstein Out-of-Hospital Cardiac Arrest Registry template - ILCOR Scientific Statement."
Detailed description
Frequency and Clinical Characteristics of Out-of-Hospital Cardiac Arrest in Poland in 2023
Background and Objective
Out-of-hospital cardiac arrest (OHCA) is a major public health concern and, according to the 2021 European Resuscitation Council guidelines, sudden cardiac arrest is the third leading cause of death in Europe cprguidelines.eu
. Despite its significance, Poland lacks a comprehensive national registry for OHCA, and complete nationwide data have not been available. This study is designed to fill that gap by determining the incidence of OHCA in Poland during 2023 and describing the clinical characteristics of these cases.
Methods
Study Design: This is a retrospective observational study analyzing all OHCA events that occurred in Poland in the year 2023. The study will use de-identified patient data drawn from official emergency medical service records. Data Sources: OHCA cases will be identified from the Emergency Medical Procedure Records (Karty Medycznych Czynności Ratunkowych, KMCR) for 2023. These records will be obtained through the National Emergency Medical Services Monitoring Center in collaboration with the Ministry of Health and the Polish Medical Air Rescue. All records will be anonymized by the data providers before being released to the research team to ensure patient confidentiality. In addition, publicly available demographic statistics from Statistics Poland (GUS) will be incorporated to provide context regarding population and regional distribution. Data Analysis: The collected data will be analyzed following the standardized Utstein-style template for reporting cardiac arrest, using the latest 2024 update for out-of-hospital cardiac arrest registries (as recommended by the International Liaison Committee on Resuscitation). This framework will ensure consistent definitions and allow benchmarking against international data. Key variables to be examined include the frequency (incidence) of OHCA, patient demographics (such as age and sex), circumstances of the arrest (e.g. location, whether it was witnessed, initial ECG rhythm), the interventions performed by bystanders and emergency medical services (such as CPR and defibrillation), and patient outcomes (including return of spontaneous circulation and survival to hospital admission). By adhering to the Utstein reporting guidelines, the study's findings will be comparable with other regional and international OHCA data, thereby enhancing their utility for epidemiological insight.
Significance
This study will provide the first comprehensive overview of OHCA occurrences across Poland for an entire year. The results are expected to furnish critical epidemiological data on how often cardiac arrests happen outside of hospitals and what clinical factors characterize these events. Such information is essential for public health authorities and medical professionals to understand current gaps in the chain of survival, to plan targeted interventions, and to improve resuscitation outcomes. Ultimately, the knowledge gained from this nationwide analysis can guide policy and training initiatives aimed at reducing mortality from sudden cardiac arrest.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| OHCA | – | –OHCA in Oland in 2023. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults (≥18 years) who experienced an OHCA in 2023, identified through MEPCs
Key inclusion criteria (3 listed)
- Adults (≥18 years) who experienced an OHCA in 2023, identified through MEPCs containing at least one of the following indicators:
- ICD-10 codes: I46, R98, R96 in the diagnosis section. Witness-reported initiation of CPR in the patient examination section. Indication of cardiac arrest in the symptoms table. Documented rhythms such as VF/VT, asystole, or PEA in the ECG table. Noted interventions like manual/mechanical chest compressions or defibrillation in the patient management table.
- Reasons for cessation of resuscitation efforts in the death/discontinuation table.
Key exclusion criteria (1 listed)
- Individuals under 18 years of age.
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
OHCA
Time frame: 1 year
Number of OHCA in Poland in 2023
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 29 Apr 2025.
- Individual participant dataSharing planned: Yes. Yes, individual participant data (IPD) that underlie the results reported in this study will be made available upon reasonable request. Interested researchers may contact the corresponding author via email to obtain access, contingent upon appropriate data use agreements and ethical approvals.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiac Complications and Sudden Cardiac Arrest, run by Medical University of Gdansk at 1 site in Poland.
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 3 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: under way, not looking for participants, as of the sponsor's last update on 29 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
OHCA (time frame: 1 year). 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 29 Apr 2025.