Skip to main content
OpenTrials
Completed

NCT Number: NCT03150940

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Age range

18 year–22 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Duke University

Durham, North Carolina, 27705, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ECG

Diagnostic Test

12 lead electrocardiogram used to demonstrate cardiac function

bedside cardiac ultrasound

Diagnostic Test

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

Primary outcomes

  1. Estimates of false positive rates for use of ultrasound and electrocardiogram

    Time frame: 1 month

    Comparing the false positive rates of use of ultrasound and electrocardiogram

Secondary outcomes

  1. To compare the rate of accuracy for athletic screenings.

    Time frame: 1 month

    To compare how observing data collectors make assessments for collected data.

Other outcomes

  1. The feasibility of quality data collection.

    Time frame: 1 month

    As measured by estimated cost and access to resources.

  2. The mean estimated time to complete this study

    Time frame: 1 month

    Measured by work hours and time to collect the data

Sponsors and collaborators

Lead sponsor

Duke University

Other

Registry information

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
May 12, 2017
Registry last updated
Nov 17, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.