Clinical trial NCT06518252: Risk of Sudden Cardiac Death in UN Athletes
Official title: Detection of the Risk of Sudden Cardiac Death in Athletes From the Universidad Nacional de Colombia
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Death, Sudden, Cardiac
Electrocardiogram QT Prolonged
Athlete Heart
Athletic Injuries
Keywords: Sudden death of the athlete
Electrocardiogram
University sports.
Lead sponsor: Universidad Nacional de Colombia
Sponsor class: OTHER
First posted: 2024-07-24
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Detailed description: Methodological Framework Research Question: What is the prevalence of sudden death risk and its predisposing factors in athletes belonging to the sports teams of the Univerisdad Nacional de Colombia - Bogotá campus aged between 18 and 35 years?

General Objective: To identify the prevalence of sudden death risk and its predisposing factors in athletes belonging to the sports teams of the National University of Colombia - Bogotá campus aged between 18 and 35 years.

Specific Objectives: 1. Characterize athletes belonging to the sports teams based on 12-lead ECG electrocardiographic activity, 2. Establish predisposing risk factors associated with sudden death in UNAL athletes belonging to the sports teams, 3. Determine the relationship between sudden death risk and predisposing factors related to cardiovascular risk, medical history, and training loads, intensities, and volumes.

Working Hypothesis. H1: Among the evaluated athletes, there will be a prevalence of sudden death risk equal to or greater than that reported in the literature. H0: The prevalence of sudden death risk found in the research will be lower than that reported in the literature.

Statistical Hypothesis. H1: The risk of sudden death is 3% to 5% higher in an athlete compared to a non-athlete. H0: The risk of sudden death is less than 3% in an athlete compared to a non-athlete.

Recruitment and Dissemination of Research Project Call. A recruitment process for participants will be carried out using an internal engagement model targeting members of the UNAL sports teams through the snowball sampling method.

Protocol for ECG Acquisition. The examination to be used for the application of a 12-lead electrocardiogram (ECG) to detect the risk of sudden death in athletes, considered the Gold Standard by the SEC and AHA. There are 6 precordial leads, and 4 limb leads, both upper and lower limbs. The person responsible for the ECG acquisition will be the principal investigator, who has completed the full course on ECG acquisition and interpretation from the Colombian Association of Cardiology and Cardiovascular Surgery. In case the principal investigator cannot participate in the complete acquisition of the ECG, the sports medicine physician from the specific area will perform the acquisition. The following protocol for ECG acquisition will be used:

1. Subject reception.
2. Registration of personal information and sports modality.
3. Review of ECG acquisition criteria.
4. Explanation of the procedure to the athlete (it is crucial to emphasize that they should not move during the examination as this may alter the results).
5. Explanation of the informed consent process (Annex 2), procedures to be performed, potential results, benefits, and assurance of respect and confidentiality of the collected information during the research, followed by signing the informed consent form.
6. A rest period of 2 minutes in complete calmness.
7. Inquiry about and removal of metallic items in the body such as prosthetics, hearing aids, piercings, among others, that may cause interference in the results.
8. Cleaning of the areas where the electrodes will be placed, both central and peripheral. This cleaning can be done with 70% alcohol wipes.
9. Application of conductive gel on each electrode, both central and peripheral.
10. Placement of each electrode in each site: 6 precordial, 2 on upper limbs, and 2 on lower limbs.
11. Recording the electrocardiogram for 2 minutes.
12. After the ECG acquisition, removal of electrodes and excess conductive gel.
13. Delivery of ECG results to the sports medicine specialist, who reads and records the findings of the examination.

In addition to the acquisition, there is also a registration process that must be done when interpreting an ECG: 1. Full name of the patient, 2. Sports discipline, 3. Taking or verifying the heart rate, 4. Determining the presence or absence of risk, 5. Archiving information in folders designated by the researchers.

Statistical Determination Descriptive. For the descriptive analysis of the characteristics of the study population and variables on a qualitative measurement scale, frequencies and proportions will be used. Continuous variables will be described using measures of central tendency (mean and median) and dispersion (standard deviation, interquartile range) according to whether normal distribution is present or not, based on graphical methods (histograms, scatter plots, among others) and numerical methods (Shapiro-Wilk).

Inferential. A correlation analysis will be conducted between secondary variables and their association with sudden death using a logistic regression model. The variables used will include: Age, Gender, Sport modality, Training volume, Training intensity.

Statistics. Prevalence, used to quantify the proportion of individuals in a population at risk of sudden death at the time of measurement, Prevalence rates, quantify the proportion of individuals in a population at risk of sudden death over a certain time, Prevalence difference, used to compare the prevalence described in the research project with that found in other studies with similar methodological characteristics, Odds ratio, used to measure the relationship between athletes exposed to a certain volume and intensity with risk/those who do not present risk.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Sudden death due to ventricular hypertrophy.
timeFrame: 8 months
measure: Sudden death due right bundle branch block
timeFrame: 8 months
measure: Sudden death due to repolarization pattern
timeFrame: 8 months
measure: Sudden death due to ST elevation
timeFrame: 8 months
Secondary outcomes:
measure: Sporting modality
timeFrame: 8 months
measure: Training volume
timeFrame: 8 months
measure: Borg scale modified.
timeFrame: 8 months
measure: Weekly Training Frequency
timeFrame: 8 months
Other outcomes:
measure: Age
timeFrame: 8 months
measure: Sex
timeFrame: 8 months
Locations:
city: Bogotá
country: Colombia
facility: Juan Murillo-Coca
state: Cundinamarca
Study officials:
affiliation: Universidad Nacional de Colombia
name: Wilder Villamil-Parra, PhD.Sciences
role: STUDY_DIRECTOR
affiliation: Universidad Nacional de Colombia
name: Erica Mancera-Soto, PhD.Sciences
role: STUDY_CHAIR
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