Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06518252
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-06-12
Brief Title:
Risk of Sudden Cardiac Death in UN Athletes
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Detection of the Risk of Sudden Cardiac Death in Athletes From the Universidad Nacional de Colombia
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Suddendeath
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 hearts 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 projects 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
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 hearts 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 projects 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 riskthose who do not present risk
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 riskthose who do not present risk
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None