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

NCT ID: NCT03150940

Last Updated: 2017-11-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

42 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-05-08

Study Completion Date

2017-07-30

Brief Summary

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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

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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

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Athletes Heart

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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

ECG

Intervention Type DIAGNOSTIC_TEST

12 lead electrocardiogram used to demonstrate cardiac function

bedside cardiac ultrasound

Intervention Type DIAGNOSTIC_TEST

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

Interventions

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ECG

12 lead electrocardiogram used to demonstrate cardiac function

Intervention Type DIAGNOSTIC_TEST

bedside cardiac ultrasound

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

22 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Duke University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Blake Boggess, DO

Role: PRINCIPAL_INVESTIGATOR

Associate Professor of Clinical Sports Medicine

Locations

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Duke University

Durham, North Carolina, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 24583295 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19221222 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24619464 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17030703 (View on PubMed)

Other Identifiers

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Pro00069459

Identifier Type: -

Identifier Source: org_study_id