Athletes HeartNCT03150940
Changing the Pulse of Athletics: Applying a Standardized Cardiac Athletic Screening for NCAA Athletes
An observational study of Athletes Heart, run by Duke University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 22 yearsHealthy volunteers can take part
- Conditions the study is for
- Athletes Heart
- What is being tested?
- ECG and bedside cardiac ultrasound
- How many people
- 42 participants
- Where
- 1 siteUnited States
- Study dates
- 8 May 2017to 30 Jul 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 22 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Participants in NCAA Division 1 collegiate athletics at Duke University are eligible to participate in the study.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Athletes Heart
- Being tested
- ECG, bedside cardiac ultrasound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ECGDiagnostic test
12 lead electrocardiogram used to demonstrate cardiac function
bedside cardiac ultrasoundDiagnostic test
bedside cardiac ultrasound to see 2D images of each participants heart. Without the use of radiation.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Diagnostic Test: ECG; Diagnostic Test: bedside cardiac ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Estimates of false positive rates for use of ultrasound and electrocardiogram
Comparing the false positive rates of use of ultrasound and electrocardiogram
Measured: 1 month
Secondary outcomes (1)
To compare the rate of accuracy for athletic screenings.
To compare how observing data collectors make assessments for collected data.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2017
- Study start8 May 2017
- Primary completion30 Jul 2017
- Study completion30 Jul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Athletes HeartStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Blake Boggess, DO, Principal investigator, Associate Professor of Clinical Sports Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03150940
- Sponsor's protocol ID
- Pro00069459
- Status last verified
- Nov 2017
- First submitted
- 14 Apr 2016
- Last updated
- 17 Nov 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 24583295Maron 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.
PubMed 19221222Sheikh 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.
PubMed 24619464Maron 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.
PubMed 17030703
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Changing the Pulse of Athletics: Applying a Standardized Cardiac Athletic Screening for NCAA Athletes
- ClinicalTrials.gov ID
- NCT03150940
- Acronym / sponsor ID
- Pro00069459
- Conditions
- Athletes Heart
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- 8 May 2017 (actual)
- Primary completion
- 30 Jul 2017 (actual)
- Study completion
- 30 Jul 2017 (actual)
- First posted
- 12 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Duke University Athletes | – | Diagnostic Test: ECG, Diagnostic Test: bedside cardiac ultrasoundDivision 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 |
Who may qualify
- Ages
- 18 to 22 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Participants in NCAA Division 1 collegiate athletics at Duke University are eligible to participate in the study.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ECG12 lead electrocardiogram used to demonstrate cardiac function | Diagnostic test | Duke University Athletes |
| bedside cardiac ultrasoundbedside cardiac ultrasound to see 2D images of each participants heart. Without the use of radiation. | Diagnostic test | Duke University Athletes |
Primary outcome
Estimates of false positive rates for use of ultrasound and electrocardiogram
Time frame: 1 month
Comparing the false positive rates of use of ultrasound and electrocardiogram
1 secondary outcome
To compare the rate of accuracy for athletic screenings.
Time frame: 1 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2017.
- Background: PubMed 24583295Maron 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.
- Background: PubMed 19221222Maron 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.
- Background: PubMed 24619464Sheikh 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.
- Background: PubMed 17030703Maron 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Blake Boggess, DO principal investigator
Associate Professor of Clinical Sports Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Athletes Heart, run by Duke University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Estimates of false positive rates for use of ultrasound and electrocardiogram (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03150940, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Nov 2017.