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.

Study Overview

• Status: Completed
• Conditions: Athletes Heart
• Intervention / Treatment: Diagnostic test: ECG; Diagnostic test: bedside cardiac ultrasound

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 Type: Observational
• Enrollment (Actual): 42

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Durham, North Carolina, United States, 27705
      • Duke University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 22 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Participants in NCAA Division 1 collegiate athletics at Duke University are eligible to participate in the study.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Duke University Athletes; 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

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
To compare the rate of accuracy for athletic screenings.	To compare how observing data collectors make assessments for collected data.	1 month

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
The feasibility of quality data collection.	As measured by estimated cost and access to resources.	1 month
The mean estimated time to complete this study	Measured by work hours and time to collect the data	1 month

Collaborators and Investigators

• Sponsor: Duke University
• Investigators: Principal Investigator: Blake Boggess, DO, Associate Professor of Clinical Sports Medicine

Publications and helpful links

General Publications

• 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.
• 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.
• Sheikh N, Papadakis M, Ghani S, Zaidi A, Gati S, Adami PE, Carre 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.
• 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. doi: 10.1161/CIRCULATIONAHA.106.613562. No abstract available.

Study record dates

Study Major Dates

• Study Start (Actual): May 8, 2017
• Primary Completion (Actual): July 30, 2017
• Study Completion (Actual): July 30, 2017

Study Registration Dates

• First Submitted: April 14, 2016
• First Submitted That Met QC Criteria: May 11, 2017
• First Posted (Actual): May 12, 2017

Study Record Updates

• Last Update Posted (Actual): November 17, 2017
• Last Update Submitted That Met QC Criteria: November 14, 2017
• Last Verified: November 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: Pro00069459

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No