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

Athletes Heart Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03150940
• Other study ID #: Pro00069459
• Status: Completed
• Phase: N/A
• First received: April 14, 2016
• Last updated: November 14, 2017
• Start date: May 8, 2017
• Est. completion date: July 30, 2017

Study information

• Verified date: November 2017
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: July 30, 2017
• Est. primary completion date: July 30, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 22 Years

Eligibility

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.

Related Conditions & MeSH terms

• Athletes Heart

Intervention

Diagnostic Test:
• ECG
12 lead electrocardiogram used to demonstrate cardiac function
• bedside cardiac ultrasound
bedside cardiac ultrasound to see 2D images of each participants heart. Without the use of radiation.

Locations

Country	Name	City	State
United States	Duke University	Durham	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Duke University

Country where clinical trial is conducted

United States, 

References & Publications (4)

Maron BJ, Doerer JJ, Haas TS, Tierney DM, Mueller FO. Sudden deaths in young competitive athletes: analysis of 1866 deaths in the United States, 1980-2006. Circulation. 2009 Mar 3;119(8):1085-92. doi: 10.1161/CIRCULATIONAHA.108.804617. Epub 2009 Feb 16. — View Citation

Maron BJ, Haas TS, Murphy CJ, Ahluwalia A, Rutten-Ramos S. Incidence and causes of sudden death in U.S. college athletes. J Am Coll Cardiol. 2014 Apr 29;63(16):1636-43. doi: 10.1016/j.jacc.2014.01.041. Epub 2014 Feb 26. — View Citation

Maron BJ, Pelliccia A. The heart of trained athletes: cardiac remodeling and the risks of sports, including sudden death. Circulation. 2006 Oct 10;114(15):1633-44. Review. — View Citation

Sheikh N, Papadakis M, Ghani S, Zaidi A, Gati S, Adami PE, Carré F, Schnell F, Wilson M, Avila P, McKenna W, Sharma S. Comparison of electrocardiographic criteria for the detection of cardiac abnormalities in elite black and white athletes. Circulation. 2014 Apr 22;129(16):1637-49. doi: 10.1161/CIRCULATIONAHA.113.006179. Epub 2014 Mar 11. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	The feasibility of quality data collection.	As measured by estimated cost and access to resources.	1 month
Other	The mean estimated time to complete this study	Measured by work hours and time to collect the data	1 month
Primary	Estimates of false positive rates for use of ultrasound and electrocardiogram	Comparing the false positive rates of use of ultrasound and electrocardiogram	1 month
Secondary	To compare the rate of accuracy for athletic screenings.	To compare how observing data collectors make assessments for collected data.	1 month