Heart ChambersNCT06234241
Normal Values of Cardiac Measurements by Echocardiography in Chinese Based on Artificial Intelligence
An observational study of Heart Chambers, run by Tianxin Dong at 1 site in China.
Trial summary
Establish echocardiographic normal reference values of Chinese Han adults based on artificial intelligence. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Heart Chambers
- What is being tested?
- Echocardiography
- How many people
- 2,000 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2023to 31 Dec 2023
- 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: Chinese Han healthy adults
Who may be able to join
- Age ≥ 18 years; No history or clinical evidence of cardiac, cardiovascular, lung, or kidney disease; No abnormal findings on physical examination, biochemical examination, electrocardiography, or echocardiography.
Who cannot join
- Hypertension (blood pressure [BP] > 140/80 mmHg) or receiving medication for hypertension; body mass index > 30 kg/m2; total cholesterol ≥ 6.2 mmol/L, triglyceride ≥ 2.3 mmol/L, or high-density lipoprotein cholesterol < 1.0 mmol/L; endocrine diseases, such as diabetes mellitus (fasting blood glucose ≥ 7.0 mmol/L), thyroid disease, pheochromocytoma, adrenal insufficiency, and hyperaldosteronism; anemia; abnormal liver function; connective tissue diseases, such as rheumatoid arthritis, vasculitis, systemic lupus erythematosus, dermatomyositis, and scleroderma; malignancy; current pregnancy or lactation; professional sport activity; and a history of alcoholism.
Trial locations and contacts
1 site in 1 country.
China1 site
The First Hospital of China Medical University
Shenyang, Liaoning, 110001
About this study
Official title: Normal Reference Values of Cardiac Measurements by Echocardiography in Chinese Han Adults Based on Artificial Intelligence: A Multi-center Study in China
Establish echocardiographic normal reference values of Chinese Han adults based on artificial intelligence.
Read the detailed description
We will establish normal reference values for the volume, function and strain of various heart chambers of Chinese people based on the recruitment of healthy Chinese subjects.
- Conditions
- Heart Chambers
- Being tested
- Echocardiography
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EchocardiographyOther
Echocardiography was performed in all enrolled populations.
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiac volumes
Including the left and right atria and left and right ventricles
Measured: 2024-10-31
Cardiac Function
Including the left and right atria and left and right ventricles
Measured: 2024-10-31
Cardiac strain
Including the left and right atria and left and right ventricles
Measured: 2024-10-31
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2024
- Study start1 Jun 2023
- Primary completion31 Oct 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart ChambersStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tianxin Dong
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Tianxin Dong, First Hospital of China Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06234241
- Sponsor's protocol ID
- 2023-445
- Status last verified
- Jan 2024
- First submitted
- 23 Jan 2024
- Last updated
- 31 Jan 2024
- Results posted
- 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 31 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Normal Reference Values of Cardiac Measurements by Echocardiography in Chinese Han Adults Based on Artificial Intelligence: A Multi-center Study in China
- ClinicalTrials.gov ID
- NCT06234241
- Acronym / sponsor ID
- 2023-445
- Conditions
- Heart Chambers
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,000 participants (actual)
- Lead sponsor
- Tianxin DongUniversity, hospital or other
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- 31 Oct 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 31 Jan 2024 (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.
Establish echocardiographic normal reference values of Chinese Han adults based on artificial intelligence.
Detailed description
We will establish normal reference values for the volume, function and strain of various heart chambers of Chinese people based on the recruitment of healthy Chinese subjects.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Chinese Han healthy adults
Key inclusion criteria (1 listed)
- Age ≥ 18 years; No history or clinical evidence of cardiac, cardiovascular, lung, or kidney disease; No abnormal findings on physical examination, biochemical examination, electrocardiography, or echocardiography.
Key exclusion criteria (1 listed)
- Hypertension (blood pressure [BP] > 140/80 mmHg) or receiving medication for hypertension; body mass index > 30 kg/m2; total cholesterol ≥ 6.2 mmol/L, triglyceride ≥ 2.3 mmol/L, or high-density lipoprotein cholesterol < 1.0 mmol/L; endocrine diseases, such as diabetes mellitus (fasting blood glucose ≥ 7.0 mmol/L), thyroid disease, pheochromocytoma, adrenal insufficiency, and hyperaldosteronism; anemia; abnormal liver function; connective tissue diseases, such as rheumatoid arthritis, vasculitis, systemic lupus erythematosus, dermatomyositis, and scleroderma; malignancy; current pregnancy or lactation; professional sport activity; and a history of alcoholism.
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 |
|---|---|---|
| EchocardiographyEchocardiography was performed in all enrolled populations. | Other | – |
Primary outcome
Cardiac volumes
Time frame: 2024-10-31
Including the left and right atria and left and right ventricles
Cardiac Function
Time frame: 2024-10-31
Including the left and right atria and left and right ventricles
Cardiac strain
Time frame: 2024-10-31
Including the left and right atria and left and right ventricles
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 31 Jan 2024.
- 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 Heart Chambers, run by Tianxin Dong 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 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 31 Jan 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?
Cardiac volumes (time frame: 2024-10-31). The study lists 3 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 31 Jan 2024.