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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03150940
Enrollment
42
Registered
2017-05-12
Start date
2017-05-08
Completion date
2017-07-30
Last updated
2017-11-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Athletes Heart

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.

Interventions

DIAGNOSTIC_TESTECG

12 lead electrocardiogram used to demonstrate cardiac function

DIAGNOSTIC_TESTbedside cardiac ultrasound

bedside cardiac ultrasound to see 2D images of each participants heart. Without the use of radiation.

Sponsors

Duke University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 22 Years
Healthy volunteers
Yes

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.

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.

Design outcomes

Primary

MeasureTime frameDescription
Estimates of false positive rates for use of ultrasound and electrocardiogram1 monthComparing the false positive rates of use of ultrasound and electrocardiogram

Secondary

MeasureTime frameDescription
To compare the rate of accuracy for athletic screenings.1 monthTo compare how observing data collectors make assessments for collected data.

Other

MeasureTime frameDescription
The feasibility of quality data collection.1 monthAs measured by estimated cost and access to resources.
The mean estimated time to complete this study1 monthMeasured by work hours and time to collect the data

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026