Changing the Pulse of Athletics: Applying a Standardized Cardiac Athletic Screening for NCAA Athletes

Completed

• Conditions: Athletes Heart
• Interventions: Diagnostic Test: ECG; Diagnostic Test: bedside cardiac ultrasound

• Registration Number: NCT03150940
• Lead Sponsor: Duke University

Brief Summary

This is a study supported by Duke Sports Cardiology and Duke Sports Medicine with the intent to enhance the cardiovascular screening of collegiate athletes from a regional to nationally recognized program to understand and eventually reduce cardiovascular events in athletes. The data from this ongoing registry will be used to better understand, refine, and improve the current cardiovascular Duke Athlete Screening process and use this experience as a role model to expand across the ACC.

Detailed Description

The purpose of this study is to screen for and determine the prevalence of structural, functional, or electrophysiologic cardiac abnormalities in a population of young athletes using bedside cardiac ultrasound, electrocardiogram (ECG) and a physical exam.

The investigators will attempt to answer the question regarding the feasibility of screening all collegiate athletes with bedside cardiac ultrasound, ECG, and history/physical exams results in a higher sensitivity for abnormalities than screening using ECG and physical exams alone. The investigators will also analyze the cost and cost effectiveness of screening the young athlete population with bedside cardiac ultrasound. Costs will be calculated to include the amount of dollars spent on equipment, gels, and other supplies, but will not include the cost of performing the bedside cardiac ultrasound, which will be assumed as part of the physical exam. Additionally, the investigators will be gathering a number of data markers from the bedside cardiac ultrasound, including but not limited to right ventricular and left ventricular cavitary size, septal wall thickness, free ventricle wall on RV, and free ventricle wall on LV, in evaluation of the athlete's heart. The importance of these measurements is for the continued knowledge and data set analysis collection as there is limited known athletic cardiac measurements. There is minimal risk involved in this study. The investigators believe that by adding bedside cardiac ultrasound to the history, physical, and ECG, it will increase the sensitivity and specificity of screening for these life-threatening abnormalities in young athletes, and reduce the morbidity and mortality associated with these conditions.

Study Timeline

• Study First Submitted: 2016-04-14
• Study Start: 2017-05-08
• Study First Submitted QC: 2017-05-11
• Study First Posted: 2017-05-12
• Primary Completion: 2017-07-30
• Study Completion: 2017-07-30
• Status Verified: 2017-11
• Last Update Submitted: 2017-11-14
• Last Update Posted: 2017-11-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 42

Inclusion Criteria

• Athletes with previous known cardiac abnormality will be included in the study. Participants in the cardiovascular screening are young student athletes of Duke University between the ages of 18-22, of both sexes participating in their respective athletic pre-participation physical examination. Anyone who participates in NCAA Division 1 collegiate athletics is eligible to participate in the study.

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Exclusion Criteria

• Exclusions to this study include any walk-on athletes, or those not deemed a part of Duke Athletics prior to the commencement of the academic year. Also excluded will be anyone less than 18 years of age. Student athletes who do not agree to the study consent will be excluded.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Duke University Athletes	ECG	Division 1 Athletes, participating in obligatory screening prior to athletic competition every summer. The investigators are observing required study outcomes (ECGs, history and physicals, and ultrasounds) to see what is useful in the screening. * ECG: 12 lead electrocardiogram that visualizes cardiac activity * history and physical: background information about athlete's and their family history * ultrasound: bedside cardiac ultrasound to visualize 2D imaging of structural cardiac function
Duke University Athletes	bedside cardiac ultrasound	Division 1 Athletes, participating in obligatory screening prior to athletic competition every summer. The investigators are observing required study outcomes (ECGs, history and physicals, and ultrasounds) to see what is useful in the screening. * ECG: 12 lead electrocardiogram that visualizes cardiac activity * history and physical: background information about athlete's and their family history * ultrasound: bedside cardiac ultrasound to visualize 2D imaging of structural cardiac function

Primary Outcome Measures

Name	Time	Method
Estimates of false positive rates for use of ultrasound and electrocardiogram	1 month	Comparing the false positive rates of use of ultrasound and electrocardiogram

Secondary Outcome Measures

Name	Time	Method
To compare the rate of accuracy for athletic screenings.	1 month	To compare how observing data collectors make assessments for collected data.

Trial Locations

Locations (1)

Duke University; 🇺🇸 Durham, North Carolina, United States