- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06075342
Intracardiac Hemodynamics and Myocardial Strain in Athletes and First Responders (IHMS)
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.
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Sichuan
-
Chengdu, Sichuan, China, 610041
- Chengdu Sport University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- athletes and healthy control subjects without regular exercise habits;
- no specific medical history or chronic illness.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
elite athlete
training year > 10 years and weekly training time > 20 hours
|
Exercise intervention according to the training program
Other Names:
|
|
casual player
training year < 10 years and weekly training time < 20 hours
|
Exercise intervention according to the training program
Other Names:
|
|
healthy control
healthy participants with irregular exercise habits
|
Exercise intervention according to the training program
Other Names:
|
|
first responder
first responders with regular exercise training
|
Exercise intervention according to the training program
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
through study completion, an average of 1 year
|
|
myocardial strain in % using two-dimension tissue tracking
Time Frame: through study completion, an average of 1 year
|
left ventricular longitudinal strain
|
through study completion, an average of 1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
wall shear stress in pascal using vector flow mapping
Time Frame: through study completion, an average of 1 year
|
segmental wall shear stress of the left ventricle
|
through study completion, an average of 1 year
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- IHMS
- 2019YFF0301704 (Other Identifier: National Key Research and Development Program (China))
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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