Out-Of-Hospital Cardiac ArrestNCT05045729
OHCA Sports in Denmark
An observational study of Out-Of-Hospital Cardiac Arrest, run by Emergency Medical Services, Capital Region, Denmark.
Trial summary
While regular exercise is known to prevent cardiovascular disorders, exercise might also trigger acute cardiac events such as cardiac arrest. This study examines the incidence, prognosis and outcomes of out-of-hospital cardiac arrest (OHCA) related to exercise in the general population of Denmark. Read more about this study
- Who is it for?
- Ages 0 to 100 years
- Conditions the study is for
- Out-Of-Hospital Cardiac Arrest
- How many people
- 21,298 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2016to 31 Dec 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
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 0 to 100 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: This registry-based follow-up study includes data from patients in The Danish Medical Service electronical registry over a 4-year period from 2016-2019 with OHCA related to exercise.
Who may be able to join
- OHCA
Who cannot join
- EMS witnessed OHCA
About this study
Official title: Incidence, Survival and EMS-treatment of Out-of-Hospital Cardiac Arrests Related to Exercise
While regular exercise is known to prevent cardiovascular disorders, exercise might also trigger acute cardiac events such as cardiac arrest. This study examines the incidence, prognosis and outcomes of out-of-hospital cardiac arrest (OHCA) related to exercise in the general population of Denmark.
This retrospective cohort study examins all OHCAs in the Danish Cardiac Arrest Registry from 2016 to 2019 in Denmark. OHCA related to exercise were identified in the nationwide electronic database and coupled to the patient register. OHCA related to exercise was defined as occurring during or up to one hour after exercise of moderate or vigorous intensity. Descriptive statistics are used together with an adjusted multivariate logistic regression model to assess predefined factors of interest.
Read the detailed description
The Danish Emergency Medical System (EMS) introduced a nationwide registry of electronic medical reports in 2016.(1) This report system allows electronic searches and thereby the opportunity to identify subgroups of out-of-hospital cardiac arrests (OHCA). Thus, this novel reporting enables the possibility to investigate new characteristics in OHCA related to exercise.
Exercise and physical activity have been shown to reduce the risk of cardiovascular disease, in spite of this, exercise can be related to a transient increased risk of cardiac events including sudden cardiac arrest.(2) Literature have reported low annual incidences of OHCA related to exercise between 0.48 - 2.1 per 100.000 person-years. (3-7) With the proportion of OHCA related to exercise of 0.3 - 7 % of all OHCA's (4,8,9). No standardized definition of timeframe concerning OHCA related to exercise is established, but throughout the literature onset of symptoms is defined to be during or up to one hour after exercise(4,5,10,11). Overall survival rates among previous studies varies from 11 - 46.2 % (6,12), a 30-day survival rate between 5.5 - 58 % (8,13) and a survival to discharge between 15.7 - 77 % (4,5,9,10,14). Yet, data is assessed in different countries with different health care systems, in different subgroups of age and lastly throughout different periods of time. This suggests further investigations and cohesion to standardized reporting, advocating for the Utstein Reporting Template. (15) Despite conflicting results regarding survival, there is consensus that exercise related OHCA has a better prognosis compared to OHCA not related to exercise. (4-6,8-10,16,17) Another consistent finding is younger age among patients suffering from OHCA related to exercise compared to other OHCA's. (5,6,9,10,17)
The etiology is often classified as either of (presumed) cardiac etiology or of non-cardiac etiology. (15) The Utstein Model suggests a method of which the pathogenesis is categorized under either medical (presumed cardiac or unknown or other medical i.e., gastro-intestinal bleed, anaphylaxis etc.) or traumatic cause, drug overdose, drowning, electrocution or asphyxia (external). If more than one cause is potential, the most likely should be noted.(18) In addition, it is suggested, that OHCA related to exercise often is caused by a presumed cardiac etiology. (4,5,7).
A better understanding and enhanced knowledge of the epidemiology of OHCA during exercise, could be useful for appropriate handling of these situations, thus this study aims to:
- Report the national incidence of exercise related OHCA's among cases attended by the Danish Medical Emergency System (EMS).
- To assess survival defined as return of spontaneous circulation (ROSC) and 30-day survival
- Finally, to evaluate aspects associated with better outcome including localization, observation of occurrence, bystander CPR, initial rhythm, use of defibrillator and patient demographics.
Materials and Methods This registry-based follow-up study includes data from patients in The Danish Medical Service electronical registry over a 4-year period from 2016-2019 with OHCA related to exercise.
Data Data on OHCA's with attempted resuscitation in Denmark have been collected in the electronic based Danish Medical Service reporting system since 2016. The registry covers detailed data including the EMS report. The data consists of executive entries and advanced text searches of prehospital charts in conjunction, augmenting the identification and collecting all OHCA's in Denmark. All cases have been through an elaborate validation process of which all identified events were read through manually. This was conducted by an external verification team to corroborate high quality of data throughout the approximately 5200 cases of OHCA in Denmark annually. Within this practice of verification, supplementary sources of data have been linked to each individual case of OHCA; information of certain interest was survival, localization, initiation of bystander CPR and actions from EMS personnel.
Identification of OHCA related to exercise This study evaluates OHCA related to exercise. All cases of OHCA were assessed and coupled to the electronic prehospital medical record, which, in context, facilitates advanced text searching in the complete electronic prehospital medical reporting system. Hence did the external validation team mark all charts consisting information about localization and type of exercise. All case descriptions in the prehospital medical records of OHCA occurring at sporting facilities were reviewed. Regarding events outside a sporting facility following terms were marked: Cases were categorized and afterwards classified in 6 subgroups; Team sports (Soccer, Handball, Volleyball, Tennis and Badminton), Fitness (Gymnastics, Aerobic, Cross Fit, Weight Lifting, Strength Training, Dancing, Yoga, Pilates, Athletics), Running/Jogging (Marathon, Ironman, Triathlon, Running, Jogging, Power walking, Roller-skating), Cycling (Cycling, Mountain Biking, Spinning), Water Sports (Swimming, Sailing, Surfing, Kitesurfing, Rowing, Kayaking) and lastly Miscellaneous (Bowling, Hunting, Golf, Equestrian sports) and their derivatives. (19,20) Furthermore time of onset of symptoms were marked in relation to the activity.
Identification of presumed causes Three individual raters will go through data to independently identify presumed causes of OHCA related to exercise. This evaluation will categorize cases as either presumed reversible or presumed non-reversible. Cases will be assessed based on the Utstein model regarding etiology. Including presumed cardiac or unknown or other medical, or traumatic cause, drug overdose, drowning, electrocution or asphyxia (external) etiology supported by a free-text description. Any discrepancy or ambiguity will be undertaken by third party members. Cases with lack of valuable information concerning cause or if several conflicting causalities is present will be labelled as "NA" or "Inconclusive" respectively. Contingent on an obviously causality between chronical disease and the presentation of the case and no plausible reversible causes, the case will be labelled non-reversible.
Variables included
- Age: Age will be defined as the subject age at the time of the event.
- Gender: Gender will be stated as either male, female or undetermined derived from personal identification numbers. Gender will be characterized based on EMS-charts, in those cases without an identification number.
- Initial rhythm: The initial rhythm will be defined as the first rhythm observed by EMS personnel, and categorized as either shockable, non-shockable (asystole), non-shockable (other) or undetermined.
- Etiology of cardiac arrest: Presumed causes will be stated as either presumed cardiac, other medical cause, trauma, drug overdose, drowning, electrocution or hypoxemia (external).
- Location of Incidence: Location will be characterized as either; sport facilities, gym, residential area, outdoors and nature, private home or other.
- Observation of occurrence: Cardiac arrests will be defined as either unwitnessed, bystander witnessed or EMS-witnessed.
- Cardio-pulmonary-resuscitation (CPR): CPR will include bystander-initiated CPR and EMS treatment with CPR.
- Defibrillation and use automatic external defibrillators (AEDs): Defibrillation will include defibrillation by bystanders and/or EMS personnel. Use of AED's includes using the device also in the case it did not deliver shocks.
- EMS-response time: This will be defined as the time between a dispatcher receiving the emergency call and the arrival of the first EMS-personnel.
- Hospitalization: Hospitalization will be considered as either; transported to hospital or declared dead by EMS-personnel.
- Return-of-spontaneous-circulation (ROSC): ROSC will be classified as the achievement of ROSC anytime between recognition of the event and termination (defined as either hospital admission or declaration of death by EMS-personnel).
- State at hospital admission: State of the case upon arrival at the hospital will be defined as either ROSC or ongoing CPR.
- Survival: Survival will be defined as ROSC at the time of hospital admission, additionally 30-day survival will be included, this derived from data from the National Patient Registry.
Analysis All data will be pseudo-anonymized, and all analyses will be accomplished on an aggregated nationwide level. Data is collected using the STrengthening the Reporting of OBservational studies in Epidemiology (STROBE) statement. The objective of this study is to clarify etiology, descriptive data and prehospital interventions of OHCA's related to exercise. Secondary an update of the annual incidence and survival rate is carried out. Descriptive statistics includes the above-mentioned variables labelled with absolute numbers and percentages. Comparative analyses will be carried out using non-parametric testing to examine subgroups. Forward logistic regression analysis will be performed for multivariate analysis. Odds ratio for survival will be calculated stratified by etiology, localization, bystander and EMS-actions.
Data storage Data is stored on secure drive according to the regional instructions for safe conduct of data management.
Ethical considerations GDPR will be followed according to danish law and the study is registered and approved at the Danish Data Protection Agency, capital region of Denmark (reference 2007-58-0015, GEH-2014-019, I-suite 02737). Since it is a registry-based study, no ethical approval is required.
Perspectives This study provides novel information regarding OHCA related to exercise; the descriptive statistics provides relevant data based on a reviewed, high-quality database. Furthermore, throughout analyses, a better understanding of the preceding circumstances and etiology might contribute to improve handling this type of arrests. This, eventually through the use of campaigns targeted laypersons and healthcare personnel.
Publication The final results are targeted for publication in an international peer reviewed journal. Participation as coauthors will be decided according to the Vancouver criteria or acknowledged for providing access to data. All Danish regional EMS regions will receive this manuscript prior to publication for eventual comments.
List of Abbreviations AED: Automatic External Defibrillator CPR: Cardio Pulmonary Resuscitation EMS: Emergency Medical Services GDPR: General Data Protection Regulation OHCA: Out-of-Hospital Cardiac Arrest ROSC: Return of Spontanous Circulation STROBE: STrengthening the Reporting of OBservational studies in Epidemiology
References
- Lindskou TA, Mikkelsen S, Christensen EF, Hansen PA, Jørgensen G, Hendriksen OM, et al. The Danish prehospital emergency healthcare system and research possibilities. Scand J trauma, Resusc Emerg Med. 2019;27(1):100.
- Friedewald VE, Spence DW. Sudden cardiac death associated with exercise: the risk-benefit issue. Am J Cardiol. 1990;66(2):183-8.
- Marijon E, Bougouin W, Celermajer DS, Perier M-C, Benameur N, Lamhaut L, et al. Major regional disparities in outcomes after sudden cardiac arrest during sports. Eur Hear journal. 2013;34(47):3632-40.
- Eastwood D, Andrew E, Smith K, Nair R, Nehme Z, Bernard S, et al. Exercise-related out-of-hospital cardiac arrest in Victoria, Australia. Resuscitation. 2019;139:57-64.
- Edwards MJ, Fothergill RT. Exercise-related sudden cardiac arrest in London: incidence, survival and bystander response. Open Hear. 2(1):e000281.
- Berdowski J, de Beus MF, Blom M, Bardai A, Bots ML, Doevendans PA, et al. Exercise-related out-of-hospital cardiac arrest in the general population: incidence and prognosis. Eur Hear journal. 2013;34(47):3616-23.
- Holst AG, Winkel BG, Theilade J, Kristensen IB, Thomsen JL, Ottesen GL, et al. Incidence and etiology of sports-related sudden cardiac death in Denmark-Implications for preparticipation screening. Hear Rhythm. 2010 Oct;7(10).
- Kiyohara K, Sado J, Matsuyama T, Nishiyama C, Kobayashi D, Kiguchi T, et al. Out-of-hospital cardiac arrests during exercise among urban inhabitants in Japan: Insights from a population-based registry of Osaka City. Resuscitation. 2017;117:14-7.
- Søholm H, Kjaergaard J, Thomsen JH, Bro-Jeppesen J, Lippert FK, Køber L, et al. Myocardial infarction is a frequent cause of exercise-related resuscitated out-of-hospital cardiac arrest in a general non-athletic population. Resuscitation. 85(11):1612-8.
- Toukola TM, Kauppila JP, Pakanen L, Kortelainen M-L, Martikainen M, Huikuri H V., et al. Characteristics and Prognosis of Exercise-Related Sudden Cardiac Arrest. Front Cardiovasc Med. 2018 Jul 26;5.
- Rai M, Thompson PD. The definition of exertion-related cardiac events. Br J Sports Med. 2011 Feb 1;45(2).
- Drezner JA, Chun JSDY, Harmon KG, Derminer L. Survival trends in the United States following exercise-related sudden cardiac arrest in the youth: 2000-2006. Hear Rhythm. 5(6):794-9.
- Si Oon Cheah, Marcus E H Ong MBFC. An eight year review of exercise-related cardiac arrests. Ann Acad Med Singap. 2010;
- Marijon E, Tafflet M, Celermajer DS, Dumas F, Perier M-C, Mustafic H, et al. Sports-Related Sudden Death in the General Population. Circulation. 2011 Aug 9;124(6).
- Cummins RO, Chamberlain DA, Abramson NS, Allen M, Baskett PJ, Becker L, et al. Recommended guidelines for uniform reporting of data from out-of-hospital cardiac arrest: the Utstein Style. A statement for health professionals from a task force of the American Heart Association, the European Resuscitation Council, the Heart and Stroke Foundation of Canada, and the Australian Resuscitation Council. Circulation. 1991 Aug;84(2).
- Marijon E, Uy-Evanado A, Reinier K, Teodorescu C, Narayanan K, Jouven X, et al. Sudden cardiac arrest during sports activity in middle age. Circ J Am Hear Assoc. 131(16):1384-91.
- Page RL, Husain S, White LY, Rea TD, Fahrenbruch C, Yin L, et al. Cardiac arrest at exercise facilities: implications for placement of automated external defibrillators. J Am Coll Cardiol. 62(22):2102-9.
- Perkins GD, Jacobs IG, Nadkarni VM, Berg RA, Bhanji F, Biarent D, et al. Cardiac Arrest and Cardiopulmonary Resuscitation Outcome Reports: Update of the Utstein Resuscitation Registry Templates for Out-of-Hospital Cardiac Arrest. Circulation. 2015 Sep 29;132(13).
- Danmarks statistik. https://www.statistikbanken.dk/10673.
- Idrættens Analyseinstitut. https://www.idan.dk/vidensbank/downloads/danskernes-motions-og-sportsvaner-2016/9a94e44b-4cf5-4fbe-ac89-a696011583d5. 2016.
- Conditions
- Out-Of-Hospital Cardiac Arrest
- Keywords
- Emergency Medical Services
- Medical subject headings
- Out-of-Hospital Cardiac 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 SPORTS | All OHCA, where the patient was engaged in sports at the time of the event |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival
Patients survival after OHCA
Measured: 30 days
Secondary outcomes (1)
ROSC
Patient obtains return of spontaneous circulation
Measured: Prior to hospital admittance
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2021
- Study start1 Jan 2016
- Primary completion31 Dec 2019
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Out-Of-Hospital Cardiac ArrestStudies 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
- Retrospective
- Enrolment
- 21,298 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emergency Medical Services, Capital Region, Denmark
- Sponsor type
- Other government
- Collaborators
- Region Sjælland, Region Syddanmark, Region MidtJylland Denmark, North Denmark Region, TrygFonden, Denmark
- Responsible party
- Principal investigator, Helle Collatz, Emergency Medical Services, Capital Region, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05045729
- Sponsor's protocol ID
- F-35101-01-SAWL
- Status last verified
- Sep 2021
- First submitted
- 7 Sep 2021
- Last updated
- 16 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Upon reasonable request
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incidence, Survival and EMS-treatment of Out-of-Hospital Cardiac Arrests Related to Exercise
- ClinicalTrials.gov ID
- NCT05045729
- Acronym / sponsor ID
- F-35101-01-SAWL
- Conditions
- Out-Of-Hospital Cardiac Arrest
- Keywords
- Emergency Medical Services
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 21,298 participants (actual)
- Lead sponsor
- Emergency Medical Services, Capital Region, DenmarkOther government
- Collaborators
- Region Sjælland, Region Syddanmark, Region MidtJylland Denmark, North Denmark Region, TrygFonden, Denmark
- Study start
- 1 Jan 2016 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 16 Sep 2021 (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.
While regular exercise is known to prevent cardiovascular disorders, exercise might also trigger acute cardiac events such as cardiac arrest. This study examines the incidence, prognosis and outcomes of out-of-hospital cardiac arrest (OHCA) related to exercise in the general population of Denmark.
This retrospective cohort study examins all OHCAs in the Danish Cardiac Arrest Registry from 2016 to 2019 in Denmark. OHCA related to exercise were identified in the nationwide electronic database and coupled to the patient register. OHCA related to exercise was defined as occurring during or up to one hour after exercise of moderate or vigorous intensity. Descriptive statistics are used together with an adjusted multivariate logistic regression model to assess predefined factors of interest.
Detailed description
The Danish Emergency Medical System (EMS) introduced a nationwide registry of electronic medical reports in 2016.(1) This report system allows electronic searches and thereby the opportunity to identify subgroups of out-of-hospital cardiac arrests (OHCA). Thus, this novel reporting enables the possibility to investigate new characteristics in OHCA related to exercise.
Exercise and physical activity have been shown to reduce the risk of cardiovascular disease, in spite of this, exercise can be related to a transient increased risk of cardiac events including sudden cardiac arrest.(2) Literature have reported low annual incidences of OHCA related to exercise between 0.48 - 2.1 per 100.000 person-years. (3-7) With the proportion of OHCA related to exercise of 0.3 - 7 % of all OHCA's (4,8,9). No standardized definition of timeframe concerning OHCA related to exercise is established, but throughout the literature onset of symptoms is defined to be during or up to one hour after exercise(4,5,10,11). Overall survival rates among previous studies varies from 11 - 46.2 % (6,12), a 30-day survival rate between 5.5 - 58 % (8,13) and a survival to discharge between 15.7 - 77 % (4,5,9,10,14). Yet, data is assessed in different countries with different health care systems, in different subgroups of age and lastly throughout different periods of time. This suggests further investigations and cohesion to standardized reporting, advocating for the Utstein Reporting Template. (15) Despite conflicting results regarding survival, there is consensus that exercise related OHCA has a better prognosis compared to OHCA not related to exercise. (4-6,8-10,16,17) Another consistent finding is younger age among patients suffering from OHCA related to exercise compared to other OHCA's. (5,6,9,10,17)
The etiology is often classified as either of (presumed) cardiac etiology or of non-cardiac etiology. (15) The Utstein Model suggests a method of which the pathogenesis is categorized under either medical (presumed cardiac or unknown or other medical i.e., gastro-intestinal bleed, anaphylaxis etc.) or traumatic cause, drug overdose, drowning, electrocution or asphyxia (external). If more than one cause is potential, the most likely should be noted.(18) In addition, it is suggested, that OHCA related to exercise often is caused by a presumed cardiac etiology. (4,5,7).
A better understanding and enhanced knowledge of the epidemiology of OHCA during exercise, could be useful for appropriate handling of these situations, thus this study aims to:
- Report the national incidence of exercise related OHCA's among cases attended by the Danish Medical Emergency System (EMS).
- To assess survival defined as return of spontaneous circulation (ROSC) and 30-day survival
- Finally, to evaluate aspects associated with better outcome including localization, observation of occurrence, bystander CPR, initial rhythm, use of defibrillator and patient demographics.
Materials and Methods This registry-based follow-up study includes data from patients in The Danish Medical Service electronical registry over a 4-year period from 2016-2019 with OHCA related to exercise.
Data Data on OHCA's with attempted resuscitation in Denmark have been collected in the electronic based Danish Medical Service reporting system since 2016. The registry covers detailed data including the EMS report. The data consists of executive entries and advanced text searches of prehospital charts in conjunction, augmenting the identification and collecting all OHCA's in Denmark. All cases have been through an elaborate validation process of which all identified events were read through manually. This was conducted by an external verification team to corroborate high quality of data throughout the approximately 5200 cases of OHCA in Denmark annually. Within this practice of verification, supplementary sources of data have been linked to each individual case of OHCA; information of certain interest was survival, localization, initiation of bystander CPR and actions from EMS personnel.
Identification of OHCA related to exercise This study evaluates OHCA related to exercise. All cases of OHCA were assessed and coupled to the electronic prehospital medical record, which, in context, facilitates advanced text searching in the complete electronic prehospital medical reporting system. Hence did the external validation team mark all charts consisting information about localization and type of exercise. All case descriptions in the prehospital medical records of OHCA occurring at sporting facilities were reviewed. Regarding events outside a sporting facility following terms were marked: Cases were categorized and afterwards classified in 6 subgroups; Team sports (Soccer, Handball, Volleyball, Tennis and Badminton), Fitness (Gymnastics, Aerobic, Cross Fit, Weight Lifting, Strength Training, Dancing, Yoga, Pilates, Athletics), Running/Jogging (Marathon, Ironman, Triathlon, Running, Jogging, Power walking, Roller-skating), Cycling (Cycling, Mountain Biking, Spinning), Water Sports (Swimming, Sailing, Surfing, Kitesurfing, Rowing, Kayaking) and lastly Miscellaneous (Bowling, Hunting, Golf, Equestrian sports) and their derivatives. (19,20) Furthermore time of onset of symptoms were marked in relation to the activity.
Identification of presumed causes Three individual raters will go through data to independently identify presumed causes of OHCA related to exercise. This evaluation will categorize cases as either presumed reversible or presumed non-reversible. Cases will be assessed based on the Utstein model regarding etiology. Including presumed cardiac or unknown or other medical, or traumatic cause, drug overdose, drowning, electrocution or asphyxia (external) etiology supported by a free-text description. Any discrepancy or ambiguity will be undertaken by third party members. Cases with lack of valuable information concerning cause or if several conflicting causalities is present will be labelled as "NA" or "Inconclusive" respectively. Contingent on an obviously causality between chronical disease and the presentation of the case and no plausible reversible causes, the case will be labelled non-reversible.
Variables included
- Age: Age will be defined as the subject age at the time of the event.
- Gender: Gender will be stated as either male, female or undetermined derived from personal identification numbers. Gender will be characterized based on EMS-charts, in those cases without an identification number.
- Initial rhythm: The initial rhythm will be defined as the first rhythm observed by EMS personnel, and categorized as either shockable, non-shockable (asystole), non-shockable (other) or undetermined.
- Etiology of cardiac arrest: Presumed causes will be stated as either presumed cardiac, other medical cause, trauma, drug overdose, drowning, electrocution or hypoxemia (external).
- Location of Incidence: Location will be characterized as either; sport facilities, gym, residential area, outdoors and nature, private home or other.
- Observation of occurrence: Cardiac arrests will be defined as either unwitnessed, bystander witnessed or EMS-witnessed.
- Cardio-pulmonary-resuscitation (CPR): CPR will include bystander-initiated CPR and EMS treatment with CPR.
- Defibrillation and use automatic external defibrillators (AEDs): Defibrillation will include defibrillation by bystanders and/or EMS personnel. Use of AED's includes using the device also in the case it did not deliver shocks.
- EMS-response time: This will be defined as the time between a dispatcher receiving the emergency call and the arrival of the first EMS-personnel.
- Hospitalization: Hospitalization will be considered as either; transported to hospital or declared dead by EMS-personnel.
- Return-of-spontaneous-circulation (ROSC): ROSC will be classified as the achievement of ROSC anytime between recognition of the event and termination (defined as either hospital admission or declaration of death by EMS-personnel).
- State at hospital admission: State of the case upon arrival at the hospital will be defined as either ROSC or ongoing CPR.
- Survival: Survival will be defined as ROSC at the time of hospital admission, additionally 30-day survival will be included, this derived from data from the National Patient Registry.
Analysis All data will be pseudo-anonymized, and all analyses will be accomplished on an aggregated nationwide level. Data is collected using the STrengthening the Reporting of OBservational studies in Epidemiology (STROBE) statement. The objective of this study is to clarify etiology, descriptive data and prehospital interventions of OHCA's related to exercise. Secondary an update of the annual incidence and survival rate is carried out. Descriptive statistics includes the above-mentioned variables labelled with absolute numbers and percentages. Comparative analyses will be carried out using non-parametric testing to examine subgroups. Forward logistic regression analysis will be performed for multivariate analysis. Odds ratio for survival will be calculated stratified by etiology, localization, bystander and EMS-actions.
Data storage Data is stored on secure drive according to the regional instructions for safe conduct of data management.
Ethical considerations GDPR will be followed according to danish law and the study is registered and approved at the Danish Data Protection Agency, capital region of Denmark (reference 2007-58-0015, GEH-2014-019, I-suite 02737). Since it is a registry-based study, no ethical approval is required.
Perspectives This study provides novel information regarding OHCA related to exercise; the descriptive statistics provides relevant data based on a reviewed, high-quality database. Furthermore, throughout analyses, a better understanding of the preceding circumstances and etiology might contribute to improve handling this type of arrests. This, eventually through the use of campaigns targeted laypersons and healthcare personnel.
Publication The final results are targeted for publication in an international peer reviewed journal. Participation as coauthors will be decided according to the Vancouver criteria or acknowledged for providing access to data. All Danish regional EMS regions will receive this manuscript prior to publication for eventual comments.
List of Abbreviations AED: Automatic External Defibrillator CPR: Cardio Pulmonary Resuscitation EMS: Emergency Medical Services GDPR: General Data Protection Regulation OHCA: Out-of-Hospital Cardiac Arrest ROSC: Return of Spontanous Circulation STROBE: STrengthening the Reporting of OBservational studies in Epidemiology
References
- Lindskou TA, Mikkelsen S, Christensen EF, Hansen PA, Jørgensen G, Hendriksen OM, et al. The Danish prehospital emergency healthcare system and research possibilities. Scand J trauma, Resusc Emerg Med. 2019;27(1):100.
- Friedewald VE, Spence DW. Sudden cardiac death associated with exercise: the risk-benefit issue. Am J Cardiol. 1990;66(2):183-8.
- Marijon E, Bougouin W, Celermajer DS, Perier M-C, Benameur N, Lamhaut L, et al. Major regional disparities in outcomes after sudden cardiac arrest during sports. Eur Hear journal. 2013;34(47):3632-40.
- Eastwood D, Andrew E, Smith K, Nair R, Nehme Z, Bernard S, et al. Exercise-related out-of-hospital cardiac arrest in Victoria, Australia. Resuscitation. 2019;139:57-64.
- Edwards MJ, Fothergill RT. Exercise-related sudden cardiac arrest in London: incidence, survival and bystander response. Open Hear. 2(1):e000281.
- Berdowski J, de Beus MF, Blom M, Bardai A, Bots ML, Doevendans PA, et al. Exercise-related out-of-hospital cardiac arrest in the general population: incidence and prognosis. Eur Hear journal. 2013;34(47):3616-23.
- Holst AG, Winkel BG, Theilade J, Kristensen IB, Thomsen JL, Ottesen GL, et al. Incidence and etiology of sports-related sudden cardiac death in Denmark-Implications for preparticipation screening. Hear Rhythm. 2010 Oct;7(10).
- Kiyohara K, Sado J, Matsuyama T, Nishiyama C, Kobayashi D, Kiguchi T, et al. Out-of-hospital cardiac arrests during exercise among urban inhabitants in Japan: Insights from a population-based registry of Osaka City. Resuscitation. 2017;117:14-7.
- Søholm H, Kjaergaard J, Thomsen JH, Bro-Jeppesen J, Lippert FK, Køber L, et al. Myocardial infarction is a frequent cause of exercise-related resuscitated out-of-hospital cardiac arrest in a general non-athletic population. Resuscitation. 85(11):1612-8.
- Toukola TM, Kauppila JP, Pakanen L, Kortelainen M-L, Martikainen M, Huikuri H V., et al. Characteristics and Prognosis of Exercise-Related Sudden Cardiac Arrest. Front Cardiovasc Med. 2018 Jul 26;5.
- Rai M, Thompson PD. The definition of exertion-related cardiac events. Br J Sports Med. 2011 Feb 1;45(2).
- Drezner JA, Chun JSDY, Harmon KG, Derminer L. Survival trends in the United States following exercise-related sudden cardiac arrest in the youth: 2000-2006. Hear Rhythm. 5(6):794-9.
- Si Oon Cheah, Marcus E H Ong MBFC. An eight year review of exercise-related cardiac arrests. Ann Acad Med Singap. 2010;
- Marijon E, Tafflet M, Celermajer DS, Dumas F, Perier M-C, Mustafic H, et al. Sports-Related Sudden Death in the General Population. Circulation. 2011 Aug 9;124(6).
- Cummins RO, Chamberlain DA, Abramson NS, Allen M, Baskett PJ, Becker L, et al. Recommended guidelines for uniform reporting of data from out-of-hospital cardiac arrest: the Utstein Style. A statement for health professionals from a task force of the American Heart Association, the European Resuscitation Council, the Heart and Stroke Foundation of Canada, and the Australian Resuscitation Council. Circulation. 1991 Aug;84(2).
- Marijon E, Uy-Evanado A, Reinier K, Teodorescu C, Narayanan K, Jouven X, et al. Sudden cardiac arrest during sports activity in middle age. Circ J Am Hear Assoc. 131(16):1384-91.
- Page RL, Husain S, White LY, Rea TD, Fahrenbruch C, Yin L, et al. Cardiac arrest at exercise facilities: implications for placement of automated external defibrillators. J Am Coll Cardiol. 62(22):2102-9.
- Perkins GD, Jacobs IG, Nadkarni VM, Berg RA, Bhanji F, Biarent D, et al. Cardiac Arrest and Cardiopulmonary Resuscitation Outcome Reports: Update of the Utstein Resuscitation Registry Templates for Out-of-Hospital Cardiac Arrest. Circulation. 2015 Sep 29;132(13).
- Danmarks statistik. https://www.statistikbanken.dk/10673.
- Idrættens Analyseinstitut. https://www.idan.dk/vidensbank/downloads/danskernes-motions-og-sportsvaner-2016/9a94e44b-4cf5-4fbe-ac89-a696011583d5. 2016.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| OHCA SPORTS | – | –All OHCA, where the patient was engaged in sports at the time of the event |
Who may qualify
- Ages
- 0 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- This registry-based follow-up study includes data from patients in The Danish Medical Service electronical registry over a 4-year period from 2016-2019 with OHCA related to exercise.
Key inclusion criteria (1 listed)
- OHCA
Key exclusion criteria (1 listed)
- EMS witnessed OHCA
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
Survival
Time frame: 30 days
Patients survival after OHCA
1 secondary outcome
ROSC
Time frame: Prior to hospital admittance
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2021.
- Individual participant dataSharing planned: Undecided. Upon reasonable request
Related trials for Out-Of-Hospital Cardiac Arrest
Active, not recruiting
The REVIVE-PEEP Trial: Positive End-expiratory Pressure Versus Sham Valve/Zero End-expiratory Pressure in Cardiopulmonary Resuscitation During Manual Ventilation to Improve Neurological Outcomes at Discharge in Adult Patients Suffering an Out-of-hospital Cardiac Arrest
Cardiac Arrest, Out-Of-Hospital
Active, not recruiting
RACE-CARS - RAndomized Cluster Evaluation of Cardiac ARrest Systems
Cardiac Arrest
RecruitingObservational study
Cardiac Arrest - Ultrasound Detection of Occult Perfusion
Cardiac Arrest, Out-Of-Hospital, Hypotension
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The OXY-VENT Study
Cardiac Arrest (CA), Cardiopulmonary Resuscitation (CPR)
Recruiting
Minimal Sedation Versus Standard Continuous Sedation After Out-of-Hospital Cardiac Arrest
Out-of-Hospital Cardiac Arrest, Hypoxic-Ischemic Brain Injury
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.
Questions about this trial
What is this clinical trial studying?
An observational study of Out-Of-Hospital Cardiac Arrest, run by Emergency Medical Services, Capital Region, Denmark.
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 1 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: status not confirmed, as of the sponsor's last update on 16 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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?
Survival (time frame: 30 days). 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 16 Sep 2021.