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临床试验/NCT06518252
NCT06518252招募中不适用

Detection of the Risk of Sudden Cardiac Death in Athletes From the Universidad Nacional de Colombia

Universidad Nacional de Colombia1 个研究点 分布在 1 个国家目标入组 250 人开始时间: 2023年11月24日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
250
试验地点
1
主要终点
Sudden death due right bundle branch block

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 35 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.

结局指标

主要结局

Sudden death due right bundle branch block

时间窗: 8 months

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

Sudden death due to ventricular hypertrophy.

时间窗: 8 months

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)

Sudden death due to repolarization pattern

时间窗: 8 months

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

Sudden death due to ST elevation

时间窗: 8 months

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

次要结局

  • Borg scale modified.(8 months)
  • Training volume(8 months)
  • Weekly Training Frequency(8 months)
  • Sporting modality(8 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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