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

NCT03150940 | Completed DMC

• 1 other identifier: Pro00069459
• Study Type: observational
• Target: 42
• Locations: 1 country
• Sites: 1

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.

Conditions

Athletes Heart

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• To compare the rate of accuracy for athletic screenings.

  1 month

Other Outcomes (2)

• The feasibility of quality data collection.

  1 month

• The mean estimated time to complete this study

  1 month

Study Arms (1)

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; Diagnostic Test: bedside cardiac ultrasound

Interventions

ECG DIAGNOSTIC_TEST

12 lead electrocardiogram used to demonstrate cardiac function

Duke University Athletes

bedside cardiac ultrasound DIAGNOSTIC_TEST

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

Duke University Athletes

Eligibility Criteria

• Age: 18 Years - 22 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

Sponsors & Collaborators

• Duke University: lead

Study Sites (1)

Duke University

Durham, North Carolina, 27705, United States

Location

Related Publications (4)

• 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.

  PMID: 24583295 BACKGROUND

• 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.

  PMID: 19221222 BACKGROUND

• 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.

  PMID: 24619464 BACKGROUND

• 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.

  PMID: 17030703 BACKGROUND

MeSH Terms

Interventions

Electrocardiography

Intervention Hierarchy (Ancestors)

Heart Function Tests; Diagnostic Techniques, Cardiovascular; Diagnostic Techniques and Procedures; Diagnosis; Electrodiagnosis

Study Officials

• Blake Boggess, DO

  Associate Professor of Clinical Sports Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 14, 2016
• First Posted: May 12, 2017
• Study Start: May 8, 2017
• Primary Completion: July 30, 2017
• Study Completion: July 30, 2017
• Last Updated: November 17, 2017

Record last verified: 2017-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)