Clinical trial NCT03150940: Changing the Pulse of Athletics: Applying a Standardized Cardiac Athletic Screening for NCAA Athletes
Official title: Changing the Pulse of Athletics: Applying a Standardized Cardiac Athletic Screening for NCAA Athletes
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Athletes Heart
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2017-05-12
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Maximum age (years): 22
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants in NCAA Division 1 collegiate athletics at Duke University are eligible to participate in the study.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Estimates of false positive rates for use of ultrasound and electrocardiogram
timeFrame: 1 month
Secondary outcomes:
measure: To compare the rate of accuracy for athletic screenings.
timeFrame: 1 month
Other outcomes:
measure: The feasibility of quality data collection.
timeFrame: 1 month
measure: The mean estimated time to complete this study
timeFrame: 1 month
Locations:
city: Durham
country: United States
facility: Duke University
state: North Carolina
Study officials:
affiliation: Associate Professor of Clinical Sports Medicine
name: Blake Boggess, DO
role: PRINCIPAL_INVESTIGATOR
References:
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.
citation: 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.
citation: 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.
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. doi: 10.1161/CIRCULATIONAHA.106.613562. No abstract available.