Cardiac Structure and FunctionIHMSNCT06075342
Intracardiac Hemodynamics and Myocardial Strain in Athletes and First Responders
An observational study of Cardiac Structure and Function and Intracardiac Hemodynamic, run by Chengdu Sport University at 1 site in China.
Trial summary
The goal of this observational study is to compare the differences of intracardiac hemodynamics and myocardial strain in athletes with different training levels to adapt to long-term high-level training in rest conditions. The main questions aim to answer are: 1. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cardiac Structure and Function, Intracardiac Hemodynamic
- What is being tested?
- exercise
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2021to 30 Jul 2024
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: athletes with training year > 10 and WTT > 20, athletes with training year < 10 and WTT < 20, healthy controls with irregular exercise habits
Who may be able to join
- athletes and healthy control subjects without regular exercise habits;
- no specific medical history or chronic illness.
Who cannot join
- A previous history of arterial hypertension, diabetes mellitus, heart, kidney, hepatic, infectious, psychiatric, malignant, disorders, taking drugs that can influence ECG intervals, and electrolyte imbalance;
- poor echocardiographic image quality and abnormal segmental ventricular wall movement.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Research of Intracardiac Hemodynamics and Myocardial Strains of Athlete's Heart
The goal of this observational study is to compare the differences of intracardiac hemodynamics and myocardial strain in athletes with different training levels to adapt to long-term high-level training in rest conditions. The main questions aim to answer are: 1. whether an increase in amplitude and duration of intracardiac hemodynamics and myocardial strain compared with healthy controls; 2. Whether significant correlations exist between the hemodynamic indices and training level.
Participants will be asked to filling out the questionnaire, such as the age, training year (the number of years the athlete has participated in any sport), technical hierarchy (promoted by the Competitive Sports Department of the General Administration of Sport of China, weekly training time in the last 6 months, height, weight, body surface area, heart rate, systolic blood pressure, and diastolic blood pressure; and will be asked to perform an examination of transthoracic echocardiography.
Researchers will compare differences of cardiac structure and function, especially the hemodynamics and myocardial strain to see if training level could affect the cardiac function through hemodynamics and myocardial strain.
- Being tested
- exercise
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
exerciseBehavioural
Also called exercise training
Exercise intervention according to the training program
| Study group | Role | What they receive |
|---|---|---|
| elite athlete | training year > 10 years and weekly training time > 20 hours Receives: Behavioral: exercise | |
| casual player | training year < 10 years and weekly training time < 20 hours Receives: Behavioral: exercise | |
| healthy control | healthy participants with irregular exercise habits Receives: Behavioral: exercise | |
| first responder | first responders with regular exercise training Receives: Behavioral: exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
intracardiac hemodynamics in mmHg/mm using vector flow mapping
intraventricular pressure gradient from left ventricular apex to base
Measured: through study completion, an average of 1 year
myocardial strain in % using two-dimension tissue tracking
left ventricular longitudinal strain
Measured: through study completion, an average of 1 year
Secondary outcomes (1)
wall shear stress in pascal using vector flow mapping
segmental wall shear stress of the left ventricle
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2023
- Study start1 Mar 2021
- Primary completion30 Jul 2023
- Study completion30 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac Structure and FunctionStudies of the same condition, open and under way.
- 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chengdu Sport University
- Sponsor type
- University, hospital or other
- Collaborators
- Institute of Sports Medicine, General Administration of Sport of China
- Responsible party
- Principal investigator, Ping Yang, Chengdu Sport University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06075342
- Sponsor's protocol ID
- IHMS
- Other IDs
- 2019YFF0301704
- Acronym
- IHMS
- Status last verified
- Jul 2024
- First submitted
- 26 Sep 2023
- Last updated
- 30 Jul 2024
- Results posted
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Research of Intracardiac Hemodynamics and Myocardial Strains of Athlete's Heart
- ClinicalTrials.gov ID
- NCT06075342
- Acronym / sponsor ID
- IHMS / IHMS
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Chengdu Sport UniversityUniversity, hospital or other
- Collaborators
- Institute of Sports Medicine, General Administration of Sport of China
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 30 Jul 2023 (actual)
- Study completion
- 30 Jul 2024 (actual)
- First posted
- 10 Oct 2023 (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.
The goal of this observational study is to compare the differences of intracardiac hemodynamics and myocardial strain in athletes with different training levels to adapt to long-term high-level training in rest conditions. The main questions aim to answer are: 1. whether an increase in amplitude and duration of intracardiac hemodynamics and myocardial strain compared with healthy controls; 2. Whether significant correlations exist between the hemodynamic indices and training level.
Participants will be asked to filling out the questionnaire, such as the age, training year (the number of years the athlete has participated in any sport), technical hierarchy (promoted by the Competitive Sports Department of the General Administration of Sport of China, weekly training time in the last 6 months, height, weight, body surface area, heart rate, systolic blood pressure, and diastolic blood pressure; and will be asked to perform an examination of transthoracic echocardiography.
Researchers will compare differences of cardiac structure and function, especially the hemodynamics and myocardial strain to see if training level could affect the cardiac function through hemodynamics and myocardial strain.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| elite athlete | – | Behavioral: exercisetraining year > 10 years and weekly training time > 20 hours |
| casual player | – | Behavioral: exercisetraining year < 10 years and weekly training time < 20 hours |
| healthy control | – | Behavioral: exercisehealthy participants with irregular exercise habits |
| first responder | – | Behavioral: exercisefirst responders with regular exercise training |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- athletes with training year > 10 and WTT > 20, athletes with training year < 10 and WTT < 20, healthy controls with irregular exercise habits
Key inclusion criteria (2 listed)
- athletes and healthy control subjects without regular exercise habits;
- no specific medical history or chronic illness.
Key exclusion criteria (2 listed)
- A previous history of arterial hypertension, diabetes mellitus, heart, kidney, hepatic, infectious, psychiatric, malignant, disorders, taking drugs that can influence ECG intervals, and electrolyte imbalance;
- poor echocardiographic image quality and abnormal segmental ventricular wall movement.
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 |
|---|---|---|
| exerciseAlso: exercise trainingExercise intervention according to the training program | Behavioural | casual player, elite athlete, first responder, healthy control |
Primary outcome
intracardiac hemodynamics in mmHg/mm using vector flow mapping
Time frame: through study completion, an average of 1 year
intraventricular pressure gradient from left ventricular apex to base
myocardial strain in % using two-dimension tissue tracking
Time frame: through study completion, an average of 1 year
left ventricular longitudinal strain
1 secondary outcome
wall shear stress in pascal using vector flow mapping
Time frame: through study completion, an average of 1 year
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 30 Jul 2024.
- Individual participant dataSharing planned: Yes
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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 Cardiac Structure and Function and Intracardiac Hemodynamic, run by Chengdu Sport University at 1 site in China.
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 2 inclusion and 2 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 30 Jul 2024. 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 China. 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?
intracardiac hemodynamics in mmHg/mm using vector flow mapping (time frame: through study completion, an average of 1 year). The study lists 2 primary outcomes in all. 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 30 Jul 2024.