Clinical Trials Directory

Trials / Completed

CompletedNCT03150940

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

Status
Completed
Phase
Study type
Observational
Enrollment
42 (actual)
Sponsor
Duke University · Academic / Other
Sex
All
Age
18 Years – 22 Years
Healthy volunteers
Accepted

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.

Conditions

Interventions

TypeNameDescription
DIAGNOSTIC_TESTECG12 lead electrocardiogram used to demonstrate cardiac function
DIAGNOSTIC_TESTbedside cardiac ultrasoundbedside cardiac ultrasound to see 2D images of each participants heart. Without the use of radiation.

Timeline

Start date
2017-05-08
Primary completion
2017-07-30
Completion
2017-07-30
First posted
2017-05-12
Last updated
2017-11-17

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT03150940. Inclusion in this directory is not an endorsement.

Changing the Pulse of Athletics: Applying a Standardized Cardiac Athletic Screening for NCAA Athletes (NCT03150940) · Clinical Trials Directory