Clinical Trial Details
— Status: Active, not recruiting
Administrative data
| NCT number |
NCT05045729 |
| Other study ID # |
F-35101-01-SAWL |
| Secondary ID |
|
| Status |
Active, not recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
January 1, 2016 |
| Est. completion date |
December 31, 2021 |
Study information
| Verified date |
September 2021 |
| Source |
Emergency Medical Services, Capital Region, Denmark |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical 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.
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.
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
1. 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.
2. Friedewald VE, Spence DW. Sudden cardiac death associated with exercise: the
risk-benefit issue. Am J Cardiol. 1990;66(2):183-8.
3. 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.
4. 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.
5. Edwards MJ, Fothergill RT. Exercise-related sudden cardiac arrest in London: incidence,
survival and bystander response. Open Hear. 2(1):e000281.
6. 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.
7. 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).
8. 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.
9. 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.
10. 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.
11. Rai M, Thompson PD. The definition of exertion-related cardiac events. Br J Sports Med.
2011 Feb 1;45(2).
12. 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.
13. Si Oon Cheah, Marcus E H Ong MBFC. An eight year review of exercise-related cardiac
arrests. Ann Acad Med Singap. 2010;
14. 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).
15. 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).
16. 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.
17. 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.
18. 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).
19. Danmarks statistik. https://www.statistikbanken.dk/10673.
20. Idrættens Analyseinstitut.
https://www.idan.dk/vidensbank/downloads/danskernes-motions-og-sportsvaner-2016/9a94e44b
-4cf5-4fbe-ac89-a696011583d5. 2016.
