Aortic AneurysmPRAADSNCT07050953
Prevalence of Ascending Aortic Dilation in Sports Medicine
An observational study of Aortic Aneurysm and Athlete, run by University Hospital, Caen at 1 site in France.
Trial summary
This study aims to assess the prevalence of ascending aortic dilation in athletes from the general population undergoing routine sports medicine evaluation. It also evaluates the predictive factors and the reproducibility of focused cardiac ultrasound. Read more about this study
- Who is it for?
- Ages 10 years and olderHealthy volunteers can take part
- Conditions the study is for
- Aortic Aneurysm, Athlete
- What is being tested?
- focused cardiac ultrasound
- How many people
- 400 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jan 2024to 1 Jun 2025
- 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 10 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: The study population includes recreational and competitive athletes aged 10 years and older who consulted the Sports Medicine Department at Caen University Hospital for a routine pre-participation cardiovascular evaluation, and who underwent focused cardiac ultrasound of the ascending aorta as part of a standardized screening protocol.
Who may be able to join
- Individuals aged 10 years and older
- Consulting for a pre-participation sports medicine evaluation at the Caen University Hospital
- No known history of cardiovascular disease
- Underwent a focused cardiac ultrasound (FCU) of the ascending aorta as part of the consultation
- Consent given for use of anonymized medical data for research purposes
Who cannot join
- Previous diagnosis of aortic disease or cardiovascular malformation
- Incomplete or non-interpretable FCU images
- Existing cardiology follow-up with echocardiography less than 3 years old
- Refusal to participate or opposition to data use
Trial locations and contacts
1 site in 1 country.
About this study
This study aims to assess the prevalence of ascending aortic dilation in athletes from the general population undergoing routine sports medicine evaluation. It also evaluates the predictive factors and the reproducibility of focused cardiac ultrasound.
Read the detailed description
Ascending aortic dilation is a potentially serious and underdiagnosed cardiovascular condition, particularly in the context of physical activity. While its prevalence has been studied in elite athletes, little data is available regarding the general athletic population undergoing routine sports medicine evaluation. This study aims to investigate the prevalence of ascending aortic dilation in a general population of recreational and competitive athletes.
This is an observational study conducted at the Sports Medicine Department of Caen University Hospital (France). The study will include athletes over the age of 10 who consult for a pre-participation medical evaluation. A focused cardiac ultrasound (FCU) protocol targeting the ascending aorta will be systematically performed using a portable ultrasound device during routine clinical assessment. When indicated, a standard transthoracic echocardiography (TTE) will be used as the reference method for comparison.
The primary objective of the study is to estimate the prevalence of ascending aortic dilation in this population. The secondary objective is to explore potential predictive factors, including cardiovascular risk factors and exercise history.
This study may help clarify the utility of FCU as a screening tool in sports medicine and contribute to improved early detection of aortic abnormalities in apparently healthy, physically active individuals. Further research may be warranted to assess long-term cardiovascular outcomes in this population.
- Conditions
- Aortic Aneurysm, Athlete
- Being tested
- focused cardiac ultrasound
- Medical subject headings
- Aortic Aneurysm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
focused cardiac ultrasoundOther
A focused cardiac ultrasound will be performed to measure the dimensions of ascending aorta
| Study group | Role | What they receive |
|---|---|---|
| Recreational and competitive Athletes | All athletes aged over 10 years consulting for routine sports medicine evaluation, regardless of sport type or performance level. Receives: Other: focused cardiac ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of Ascending Aortic Dilation in Athletes
Proportion of athletes (recreational and competitive) identified with ascending aortic dilation, as determined by focused cardiac ultrasound. Dilation is defined as an aortic diameter ≥ 40 mm and/or a Z-score ≥ 2, according to age-adjusted reference values.
Measured: Baseline
Secondary outcomes (1)
Predictive Factors for Ascending Aortic Dilation
Association between ascending aortic dilation and clinical variables, including age, sex, blood pressure, body mass index, cardiovascular risk factors, and characteristics of physical activity
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2025
- Study start1 Jan 2024
- Primary completion1 Jan 2025
- Study completion1 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aortic AneurysmStudies of the same condition, open and under way.
- More trials run by University Hospital, CaenThe 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
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Caen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07050953
- Sponsor's protocol ID
- Ao-TTE
- Acronym
- PRAADS
- Status last verified
- Mar 2025
- First submitted
- 21 Mar 2025
- Last updated
- 3 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Ascending Aortic Dilation in Sports Medicine
- ClinicalTrials.gov ID
- NCT07050953
- Acronym / sponsor ID
- PRAADS / Ao-TTE
- Conditions
- Aortic Aneurysm, Athlete
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- University Hospital, CaenUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 1 Jan 2025 (actual)
- Study completion
- 1 Jun 2025 (actual)
- First posted
- 3 Jul 2025 (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 study aims to assess the prevalence of ascending aortic dilation in athletes from the general population undergoing routine sports medicine evaluation. It also evaluates the predictive factors and the reproducibility of focused cardiac ultrasound.
Detailed description
Ascending aortic dilation is a potentially serious and underdiagnosed cardiovascular condition, particularly in the context of physical activity. While its prevalence has been studied in elite athletes, little data is available regarding the general athletic population undergoing routine sports medicine evaluation. This study aims to investigate the prevalence of ascending aortic dilation in a general population of recreational and competitive athletes.
This is an observational study conducted at the Sports Medicine Department of Caen University Hospital (France). The study will include athletes over the age of 10 who consult for a pre-participation medical evaluation. A focused cardiac ultrasound (FCU) protocol targeting the ascending aorta will be systematically performed using a portable ultrasound device during routine clinical assessment. When indicated, a standard transthoracic echocardiography (TTE) will be used as the reference method for comparison.
The primary objective of the study is to estimate the prevalence of ascending aortic dilation in this population. The secondary objective is to explore potential predictive factors, including cardiovascular risk factors and exercise history.
This study may help clarify the utility of FCU as a screening tool in sports medicine and contribute to improved early detection of aortic abnormalities in apparently healthy, physically active individuals. Further research may be warranted to assess long-term cardiovascular outcomes in this population.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Recreational and competitive Athletes | – | Other: focused cardiac ultrasoundAll athletes aged over 10 years consulting for routine sports medicine evaluation, regardless of sport type or performance level. |
Who may qualify
- Ages
- 10 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The study population includes recreational and competitive athletes aged 10 years and older who consulted the Sports Medicine Department at Caen University Hospital for a routine pre-participation cardiovascular evaluation, and who underwent focused cardiac ultrasound of the ascending aorta as part of a standardized screening protocol.
Key inclusion criteria (5 listed)
- Individuals aged 10 years and older
- Consulting for a pre-participation sports medicine evaluation at the Caen University Hospital
- No known history of cardiovascular disease
- Underwent a focused cardiac ultrasound (FCU) of the ascending aorta as part of the consultation
- Consent given for use of anonymized medical data for research purposes
Key exclusion criteria (4 listed)
- Previous diagnosis of aortic disease or cardiovascular malformation
- Incomplete or non-interpretable FCU images
- Existing cardiology follow-up with echocardiography less than 3 years old
- Refusal to participate or opposition to data use
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 |
|---|---|---|
| focused cardiac ultrasoundA focused cardiac ultrasound will be performed to measure the dimensions of ascending aorta | Other | Recreational and competitive Athletes |
Primary outcome
Prevalence of Ascending Aortic Dilation in Athletes
Time frame: Baseline
Proportion of athletes (recreational and competitive) identified with ascending aortic dilation, as determined by focused cardiac ultrasound. Dilation is defined as an aortic diameter ≥ 40 mm and/or a Z-score ≥ 2, according to age-adjusted reference values.
1 secondary outcome
Predictive Factors for Ascending Aortic Dilation
Time frame: Baseline
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 3 Jul 2025.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Aortic Aneurysm and Athlete, run by University Hospital, Caen at 1 site in France.
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 5 inclusion and 4 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 3 Jul 2025. 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 France. 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?
Prevalence of Ascending Aortic Dilation in Athletes (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Jul 2025.