Risk of Sudden Cardiac Death in UN Athletes

NCT06518252 | Recruiting

• 1 other identifier: B.FM.1.002-CE-225-23
• Study Type: observational
• Target: 250
• Locations: 1 country
• Sites: 1

Brief Summary

The detection of sudden cardiac death risk in athletes is a topic of great relevance in the field of sports physiotherapy and physical activity. High-performance sports practice involves anatomical and physiological changes that can modify the mechanical and electrical properties of the heart, increasing the risk of potentially fatal cardiac events. Therefore, it is essential to implement early detection strategies to identify at-risk athletes and prevent tragedies during sports practice. Methodology: This study focuses on the prevalence of sudden cardiac death risk, using a 12-lead electrocardiogram as the primary detection tool. This examination will allow for the evaluation of the heart's electrical activity and the detection of potential anomalies that could predispose athletes to adverse cardiac events during sports practice. In addition to the electrocardiogram, cardiovascular screening questionnaires will be administered to collect information on personal and family health histories, as well as other relevant risk factors. In conjunction with the project's researchers, the sports medical team of the Universidad Nacional de Colombia will be responsible for conducting the evaluations, ensuring the precision and reliability of the obtained results. A detailed analysis of the collected data will be performed using statistical tools to identify possible correlations between the evaluated risk factors and the presence of sudden cardiac death risk in athletes. Logistic regression models will be employed to determine the strength of association between the studied variables and cardiovascular risk in this specific population. Expected Results: It is anticipated that implementing pre-participation evaluations, including the electrocardiogram and cardiovascular screening questionnaires, will enable the identification of athletes at higher risk of sudden cardiac death. These results will allow for the establishment of individualized risk profiles and the design of personalized prevention strategies for each athlete. Additionally, it is expected that the findings of this study will contribute to the development of early detection protocols for sudden cardiac death risk in athletes, which can be effectively implemented in sports settings. The information generated from this study will provide a solid foundation for clinical decision-making and the implementation of preventive measures to benefit the health and well-being of high-performance athletes.

Conditions

Death, Sudden, Cardiac; Electrocardiogram QT Prolonged; Athlete Heart; Athletic Injuries

Keywords

Sudden death of the athlete; Electrocardiogram; University sports.

Outcome Measures

Primary Outcomes (4)

• Sudden death due to ventricular hypertrophy.

  People whose electrocardiographic findings are outside the normal parameters and who present left or right ventricular hypertrophy with isolated QRS voltage to the left side (SV1 þ RV5 or RV6 \>3.5 mV) or right ventricular hypertrophy (RV1 þ SV5 or SV6 \> 1.1mV)

  8 months

• Sudden death due right bundle branch block

  People whose electrocardiographic findings are outside normal parameters and presenting rSR0 in V1 and qRS pattern in V6 with QRS duration \<120 ms.

  8 months

• Sudden death due to repolarization pattern

  People whose electrocardiographic findings are outside the parameters of normality/ST elevation with J point elevation, ST segment elevation, J waves or dragged terminal QRS in the inferior and/or lateral leads

  8 months

• Sudden death due to ST elevation

  ST elevation followed by T wave inversion in V1-V4 in black athletes: J-point elevation and convex ("domed") ST segment elevation followed by T wave inversion in leads V1-V4 in athletes black

  8 months

Secondary Outcomes (4)

• Sporting modality

  8 months

• Training volume

  8 months

• Borg scale modified.

  8 months

• Weekly Training Frequency

  8 months

Other Outcomes (2)

• Age

  8 months

• Sex

  8 months

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Athlete population aged between 18 and 35 years, without excluding gender, belongs to the Universidad Nacional de Colombia (UN), Bogotá campus sports delegations. Measurements will be conducted in the Exercise Physiology Laboratory of the Faculty of Medicine at UN. Se realizará un proceso de reclutamiento de los participantes utilizando un modelo de enganche interno de los pertenecientes a las selecciones deportivas de la UNAL por medio del método bola de nieve.

You may qualify if:

• Athletes belonging to the sports teams of the National University of Colombia, Bogotá campus.
• Subject's sports history (practice time exceeding 2 years).
• Individuals aged 18 to 35 years, without discrimination based on biological sex.
• Training time exceeding 6 hours per week in their sports modality (weekly training record).
• Personal history of cardiovascular disease (cardiac malformations or previously detected sudden death risk).
• Athletes who attend at least 90% of the training sessions planned by the coach.

You may not qualify if:

• Personal history of metabolic (type 1 and 2 diabetes mellitus), neurological (spinal cord injury), or renal disease.
• Routine consumption of alcohol or psychoactive substances.
• Use of antihypertensive medications, beta-blockers, or inotropes.
• Cardiovascular disease diagnosed with previously established pharmacological management.

Sponsors & Collaborators

• Universidad Nacional de Colombia: lead

Study Sites (1)

Juan Murillo-Coca

Bogotá, Cundinamarca, 110821, Colombia

RECRUITING

Related Publications (12)

• Han J, Lalario A, Merro E, Sinagra G, Sharma S, Papadakis M, Finocchiaro G. Sudden Cardiac Death in Athletes: Facts and Fallacies. J Cardiovasc Dev Dis. 2023 Feb 5;10(2):68. doi: 10.3390/jcdd10020068.

  PMID: 36826564 BACKGROUND

• Sarto P, Zorzi A, Merlo L, Vessella T, Pegoraro C, Giorgiano F, Graziano F, Basso C, Drezner JA, Corrado D. Value of screening for the risk of sudden cardiac death in young competitive athletes. Eur Heart J. 2023 Mar 21;44(12):1084-1092. doi: 10.1093/eurheartj/ehad017.

  PMID: 36760222 BACKGROUND

• Sharma S, Drezner JA, Baggish A, Papadakis M, Wilson MG, Prutkin JM, La Gerche A, Ackerman MJ, Borjesson M, Salerno JC, Asif IM, Owens DS, Chung EH, Emery MS, Froelicher VF, Heidbuchel H, Adamuz C, Asplund CA, Cohen G, Harmon KG, Marek JC, Molossi S, Niebauer J, Pelto HF, Perez MV, Riding NR, Saarel T, Schmied CM, Shipon DM, Stein R, Vetter VL, Pelliccia A, Corrado D. International Recommendations for Electrocardiographic Interpretation in Athletes. J Am Coll Cardiol. 2017 Feb 28;69(8):1057-1075. doi: 10.1016/j.jacc.2017.01.015.

  PMID: 28231933 BACKGROUND

• Vessella T, Zorzi A, Merlo L, Pegoraro C, Giorgiano F, Trevisanato M, Viel M, Formentini P, Corrado D, Sarto P. The Italian preparticipation evaluation programme: diagnostic yield, rate of disqualification and cost analysis. Br J Sports Med. 2020 Feb;54(4):231-237. doi: 10.1136/bjsports-2018-100293. Epub 2019 Jul 17.

  PMID: 31315826 BACKGROUND

• Williams EA, Pelto HF, Toresdahl BG, Prutkin JM, Owens DS, Salerno JC, Harmon KG, Drezner JA. Performance of the American Heart Association ( AHA ) 14-Point Evaluation Versus Electrocardiography for the Cardiovascular Screening of High School Athletes: A Prospective Study. J Am Heart Assoc. 2019 Jul 16;8(14):e012235. doi: 10.1161/JAHA.119.012235. Epub 2019 Jul 9.

  PMID: 31286819 BACKGROUND

• Dhutia H, MacLachlan H. Cardiac Screening of Young Athletes: a Practical Approach to Sudden Cardiac Death Prevention. Curr Treat Options Cardiovasc Med. 2018 Aug 28;20(10):85. doi: 10.1007/s11936-018-0681-4.

  PMID: 30155696 BACKGROUND

• D'Ascenzi F, Valentini F, Pistoresi S, Frascaro F, Piu P, Cavigli L, Valente S, Focardi M, Cameli M, Bonifazi M, Metra M, Mondillo S. Causes of sudden cardiac death in young athletes and non-athletes: systematic review and meta-analysis: Sudden cardiac death in the young. Trends Cardiovasc Med. 2022 Jul;32(5):299-308. doi: 10.1016/j.tcm.2021.06.001. Epub 2021 Jun 22.

  PMID: 34166791 BACKGROUND

• Bassi MD, Farina JM, Bombau J, Fitz Maurice M, Bortman G, Nunez E, Marquez M, Bornancini N, Baranchuk A. Sudden Cardiac Arrest in Basketball and Soccer Stadiums, the Role of Automated External Defibrillators: A Review. For the BELTRAN Study (BaskEtbaLl and soccer sTadiums: Registry on Automatic exterNal defibrillators). Arrhythm Electrophysiol Rev. 2023 Jan;12:e03. doi: 10.15420/aer.2022.30.

  PMID: 36845166 BACKGROUND

• Egger F, Scharhag J, Kastner A, Dvorak J, Bohm P, Meyer T. FIFA Sudden Death Registry (FIFA-SDR): a prospective, observational study of sudden death in worldwide football from 2014 to 2018. Br J Sports Med. 2022 Jan;56(2):80-87. doi: 10.1136/bjsports-2020-102368. Epub 2020 Dec 23.

  PMID: 33361135 BACKGROUND

• Sims JM. A brief review of the Belmont report. Dimens Crit Care Nurs. 2010 Jul-Aug;29(4):173-4. doi: 10.1097/DCC.0b013e3181de9ec5.

  PMID: 20543620 BACKGROUND

• Ehni HJ, Wiesing U. The Declaration of Helsinki in bioethics literature since the last revision in 2013. Bioethics. 2024 May;38(4):335-343. doi: 10.1111/bioe.13270. Epub 2024 Feb 17.

  PMID: 38367022 BACKGROUND

• Sweeting J, Semsarian C. Sudden Cardiac Death in Athletes. Heart Lung Circ. 2018 Sep;27(9):1072-1077. doi: 10.1016/j.hlc.2018.03.026. Epub 2018 Apr 5.

  PMID: 29705387 BACKGROUND

MeSH Terms

Conditions

Death, Sudden, Cardiac; Long QT Syndrome; Athletic Injuries

Condition Hierarchy (Ancestors)

Heart Arrest; Heart Diseases; Cardiovascular Diseases; Death, Sudden; Death; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Arrhythmias, Cardiac; Cardiac Conduction System Disease; Heart Defects, Congenital; Cardiovascular Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Wounds and Injuries

Study Officials

• Wilder Villamil-Parra, PhD.Sciences

  Universidad Nacional de Colombia

  STUDY DIRECTOR

• Erica Mancera-Soto, PhD.Sciences

  Universidad Nacional de Colombia

  STUDY CHAIR

Central Study Contacts

Juan C Murillo-Coca, Therapist

CONTACT

(+57)3218740924; jumurilloc@unal.edu.co

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 12, 2024
• First Posted: July 24, 2024
• Study Start: November 24, 2023
• Primary Completion: December 20, 2024
• Study Completion: June 25, 2025
• Last Updated: July 24, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

CO (1)