Healthy AdultsNCT07292896
A Multicenter Study on the Normal Reference Range and Clinical Significance of the Right Atrioventricular Coupling Index Assessed by Artificial Intelligence-Based Three-Dimensional Echocardiography
An observational study of Healthy Adults and Pulmonary Hypertension, run by First Hospital of China Medical University at 25 sites in China.
Trial summary
This multicenter study aims to establish the normal reference range of the Right Atrioventricular Coupling Index (RACI) in healthy Chinese adults using AI-based 3DE technology. It will also analyze the correlation between RACI and physiological parameters such as age, gender, and body surface area. Read more about this study
- Who is it for?
- Ages 18 to 79 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Adults, Pulmonary Hypertension, Tricuspid Regurgitation
- How many people
- 2,640 participants
- Where
- 25 sitesChina
- Study dates
- Dec 2025to Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 79 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: This study enrolls 5 groups (18-79 years) from clinics/community: Healthy Adults: Han Chinese with normal cardiovascular function (vitals, labs, ECG, echo; no structural heart disease/systemic diseases/poor ultrasound). Pulmonary Hypertension: Diagnosed via right heart catheter (mPAP ≥20 mmHg, 2022 ESC/ERS); excluded if with left heart disease, interfering conditions, organ dysfunction, malignancy, or prior pulmonary surgery. Heart Failure: Meets 2022 AHA/ACC/HFSA criteria; excluded if with significant valvular disease. Tricuspid Regurgitation: Echo-confirmed moderate/severe regurgitation; excluded if with interfering pericardial/arrhythmic issues or congenital heart disease/residual lesions. Atrial Septal Defect: Echo/TEE-confirmed secundum defect (untreated or stable ≥3mo post-op); excluded if with complex congenital heart disease. All undergo standardized clinical/echo assessments for cardiac structure/function.
Who may be able to join
- Participants must meet all of the following criteria to be enrolled:
- Of Han Chinese ethnicity
- Aged 18-79 years
- Normal blood pressure (< 140/90 mmHg)
- Normal fasting blood glucose
- Normal blood lipid levels (triglycerides, total cholesterol, low-density lipoprotein, high-density lipoprotein)
Show all 23Show fewer
- Normal complete blood count results (hemoglobin concentration, white blood cell count, red blood cell count, platelet count)
- Normal liver and renal function (alanine transaminase < 2× upper limit of normal; normal creatinine and blood urea nitrogen)
- Normal electrocardiogram results (occasional atrial premature beats may be enrolled at the investigator's discretion)
- No structural heart disease and normal cardiac function confirmed by echocardiography
- Patients must meet all of the following criteria to be enrolled:
- Aged 18-79 years
- Confirmed diagnosis via right heart catheterization: mean pulmonary arterial pressure (mPAP) ≥ 20 mmHg, in accordance with the 2022 ESC/ERS guidelines
- Patients must meet all of the following criteria to be enrolled:
- Aged 18-79 years
- Meets the 2022 AHA/ACC/HFSA diagnostic criteria for heart failure
- Patients must meet all of the following criteria to be enrolled:
- Moderate or severe primary or secondary tricuspid regurgitation confirmed by echocardiography
- Aged 18-79 years
- Patients must meet all of the following criteria to be enrolled:
- Secundum atrial septal defect confirmed by echocardiography or transesophageal echocardiography
- Patients who have not undergone closure or surgical correction, or stable patients with > 3 months postoperatively
- Aged 18-79 years
Who cannot join
- Participants will be excluded if they meet any of the following criteria:
- Clinically significant cardiac valve regurgitation (≥ mild severity)
- Respiratory diseases: acute or chronic respiratory disorders
- Endocrine diseases: thyroid disease, diabetes mellitus, hyperaldosteronism, pheochromocytoma, etc.
- Abnormal liver function (alanine transaminase > 2× upper limit of normal), abnormal renal function (elevated creatinine beyond normal range), or dyslipidemia (elevated triglycerides, total cholesterol, low-density lipoprotein, or high-density lipoprotein)
- Other systemic diseases: anemia, malignancy, connective tissue disease, large artery/peripheral vascular diseases (aortic dilation, aortic dissection, coarctation of the aorta, Takayasu arteritis, atherosclerosis), etc.
Show all 27Show fewer
- Pregnant or lactating women
- Professional athletes
- Poor-quality ultrasound images that cannot support parameter measurement and analysis
- Pulmonary Hypertension Group
- Patients will be excluded if they meet any of the following criteria:
- Unable to complete right heart catheterization or pressure-volume loop assessment
- Complicated with significant left heart disease (left ventricular ejection fraction [LVEF] < 50%, significant mitral valve disease)
- Pericardial disease or arrhythmias (e.g., atrial fibrillation) that severely impair right heart function evaluation
- Poor-quality images that prevent accurate measurement of right atrial or right ventricular parameters
- Concurrent liver or renal disease
- Concurrent malignancy
- History of surgical procedures such as pulmonary endarterectomy or balloon pulmonary angioplasty
- Heart Failure Group
- Patients will be excluded if they meet any of the following criteria:
- 1.Complicated with significant valvular heart disease (e.g., severe mitral regurgitation, severe tricuspid regurgitation, etc.)
- Tricuspid Regurgitation Group
- Patients will be excluded if they meet any of the following criteria:
- Pericardial disease or arrhythmias (persistent atrial fibrillation) that interfere with measurements
- Congenital heart disease or residual lesions after surgical correction
- Atrial Septal Defect Group
- 1.Complicated with other complex congenital heart diseases.
Trial locations and contacts
25 sites in 1 country. Contact the study team or a site near you to ask about taking part.
25 sites in 1 country
China25 sites
Anshan Central Hospital
Anshan, Liaoning
Yao Wang
Ansteel Group General Hospita
Anshan, Liaoning
Gang Du, Ph.D
Beijing Chaoyang Hospital, Capital Medical University
Beijing
Yidan Li
The Second Affiliated Hospital of Jilin University
Changchun, Jilin
Dongmei Lv
Chaoyang Central Hospital
Chaoyang, Liaoning
Hong Zhou
West China Hospital，Sichuan University
Chengdu, Sichuan
Chongqing Liangjiang New Area Hospital of Traditional Chinese Medicine
Chongqing, Chongqing Municipality
Yan Zhang
the Second Hospital of Dalian Medical University
Dalian, Liaoning
Jun Wu
The First Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang
Hui Liu
The Fourth Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang
Tianle Yu
Huludao Second People's Hospital
Huludao, Liaoning
Xuan Wang
Liaohua Hospital
Liaoyang, Liaoning
Shuangyan Liu
The Affiliated Hospital of Qingdao University
Qingdao, Shandong
Shanghai Chest Hospital
Shanghai
fan li
Zhongshan Hospital, Fudan University, Shanghai
Shanghai
Xianhong Shu
The First Hospital of China Medical University
Shenyang, Liaoning, 110000
Chunyan Ma, MD, +8613998816448, mcy_echo@163.com
Chunyan Ma, MD
Shenzhen People's Hospital
Shenzhen, Guangdong
Shijiazhuang People's Hospital
Shijiazhuang, Hebei
Xiaoqing Yang
The Third Affiliated Hospital of Hebei Medical University
Shijiazhuang, Hebei
Heping Deng
Shanxi Provincial People's Hospital
Taiyuan, Shanxi
Weiqing Li
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei
The First Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shaanxi
Shun Wang
Xiangyang No.1 Peoples Hospital
Xiangyang, Hubei
Yu Wang, Ph.D
The Second Affiliated Hospital of Shaanxi University of Chinese Medicine
Xianyang, Shaanxi
Xiaoli Zhu
Henan Provincial People's Hospital
Zhengzhou, Henan
Haohui Zhu, PhD
About this study
This multicenter study aims to establish the normal reference range of the Right Atrioventricular Coupling Index (RACI) in healthy Chinese adults using AI-based 3DE technology. It will also analyze the correlation between RACI and physiological parameters such as age, gender, and body surface area. Additionally, the study will explore the variation characteristics of RACI in patients with pulmonary hypertension, heart failure, tricuspid regurgitation, and atrial septal defect, and evaluate the clinical value of RACI in disease diagnosis, differential diagnosis, and risk stratification.
- Conditions
- Healthy Adults, Pulmonary Hypertension, Tricuspid Regurgitation, Heart Failure, Atrial Septal Defect
- Keywords
- Right Atrioventricular Coupling Index, 3D Echocardiography, AI-assisted Imaging
- Medical subject headings
- Hypertension, Pulmonary, Tricuspid Valve Insufficiency, Heart Failure, Heart Septal Defects, Atrial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Healthy Adults Group | Healthy adults aged 18 to 79 years are planned to be stratified into 6 age groups: 18-29 years, 30-39 years, 40-49 years, 50-59 years, 60-69 years, and ≥70 years. Each age group will include 120 participants of each sex. | |
| Pulmonary Hypertension Group | This group comprises adults with a confirmed diagnosis of mean pulmonary artery pressure (mPAP) ≥20 mmHg via right heart catheterization, in accordance with the diagnostic criteria for pulmonary hypertension specified in the 2022 ESC/ERS Guidelines. | |
| Tricuspid Regurgitation Group | Adults with moderate or severe primary/secondary tricuspid regurgitation confirmed by echocardiography. | |
| Atrial Septal Defect Group | Adults with atrial septal defect confirmed by echocardiography or transesophageal echocardiography, including non-intervened patients, those who underwent closure/surgical correction, and stable patients > 3 months after surgery. | |
| Heart Failure Group | Adults meeting the 2022 AHA/ACC/HFSA diagnostic criteria for heart failure are classified into three subgroups based on left ventricular ejection fraction (LVEF): heart failure with reduced ejection fraction (HFrEF, LVEF < 40%), heart failure with mildly reduced ejection fraction (HFmrEF, LVEF 40-49%), and heart failure with preserved ejection fraction (HFpEF, LVEF ≥ 50%). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Right Atrioventricular Coupling Index (RACI)
RACI links the volumes of the right atrium (RA) and right ventricle (RV), with the degree of their volume matching reflecting their synergistic functional status during hemodynamic regulation
Measured: At study enrollment (baseline)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2025
- Study startDec 2025 (estimated)
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy AdultsStudies 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
- 2,640 participants (estimated)
Sponsor and investigators
- Lead sponsor
- First Hospital of China Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chunyan Ma, First Hospital of China Medical University
- Investigators
- Chunyan Ma, MD, Principal investigator, First Hospital of China Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07292896
- Sponsor's protocol ID
- 3D-RACI-01
- Status last verified
- Nov 2025
- First submitted
- 6 Dec 2025
- Last updated
- 18 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Study on the Normal Reference Range and Clinical Significance of the Right Atrioventricular Coupling Index Assessed by Artificial Intelligence-Based Three-Dimensional Echocardiography
- ClinicalTrials.gov ID
- NCT07292896
- Acronym / sponsor ID
- 3D-RACI-01
- Conditions
- Healthy Adults, Pulmonary Hypertension, Tricuspid Regurgitation, Heart Failure, Atrial Septal Defect
- Keywords
- Right Atrioventricular Coupling Index, 3D Echocardiography, AI-assisted Imaging
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 2,640 participants (estimated)
- Lead sponsor
- First Hospital of China Medical UniversityUniversity, hospital or other
- Study start
- Dec 2025 (estimated)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 18 Dec 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 multicenter study aims to establish the normal reference range of the Right Atrioventricular Coupling Index (RACI) in healthy Chinese adults using AI-based 3DE technology. It will also analyze the correlation between RACI and physiological parameters such as age, gender, and body surface area. Additionally, the study will explore the variation characteristics of RACI in patients with pulmonary hypertension, heart failure, tricuspid regurgitation, and atrial septal defect, and evaluate the clinical value of RACI in disease diagnosis, differential diagnosis, and risk stratification.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Healthy Adults Group | – | –Healthy adults aged 18 to 79 years are planned to be stratified into 6 age groups: 18-29 years, 30-39 years, 40-49 years, 50-59 years, 60-69 years, and ≥70 years. Each age group will include 120 participants of each sex. |
| Pulmonary Hypertension Group | – | –This group comprises adults with a confirmed diagnosis of mean pulmonary artery pressure (mPAP) ≥20 mmHg via right heart catheterization, in accordance with the diagnostic criteria for pulmonary hypertension specified in the 2022 ESC/ERS Guidelines. |
| Tricuspid Regurgitation Group | – | –Adults with moderate or severe primary/secondary tricuspid regurgitation confirmed by echocardiography. |
| Atrial Septal Defect Group | – | –Adults with atrial septal defect confirmed by echocardiography or transesophageal echocardiography, including non-intervened patients, those who underwent closure/surgical correction, and stable patients > 3 months after surgery. |
| Heart Failure Group | – | –Adults meeting the 2022 AHA/ACC/HFSA diagnostic criteria for heart failure are classified into three subgroups based on left ventricular ejection fraction (LVEF): heart failure with reduced ejection fraction (HFrEF, LVEF < 40%), heart failure with mildly reduced ejection fraction (HFmrEF, LVEF 40-49%), and heart failure with preserved ejection fraction (HFpEF, LVEF ≥ 50%). |
Who may qualify
- Ages
- 18 to 79 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- This study enrolls 5 groups (18-79 years) from clinics/community: Healthy Adults: Han Chinese with normal cardiovascular function (vitals, labs, ECG, echo; no structural heart disease/systemic diseases/poor ultrasound). Pulmonary Hypertension: Diagnosed via right heart catheter (mPAP ≥20 mmHg, 2022 ESC/ERS); excluded if with left heart disease, interfering conditions, organ dysfunction, malignancy, or prior pulmonary surgery. Heart Failure: Meets 2022 AHA/ACC/HFSA criteria; excluded if with significant valvular disease. Tricuspid Regurgitation: Echo-confirmed moderate/severe regurgitation; excluded if with interfering pericardial/arrhythmic issues or congenital heart disease/residual lesions. Atrial Septal Defect: Echo/TEE-confirmed secundum defect (untreated or stable ≥3mo post-op); excluded if with complex congenital heart disease. All undergo standardized clinical/echo assessments for cardiac structure/function.
Key inclusion criteria (23 listed)
- Participants must meet all of the following criteria to be enrolled:
- Aged 18-79 years
- Confirmed diagnosis via right heart catheterization: mean pulmonary arterial pressure (mPAP) ≥ 20 mmHg, in accordance with the 2022 ESC/ERS guidelines
- Aged 18-79 years
- Meets the 2022 AHA/ACC/HFSA diagnostic criteria for heart failure
Key exclusion criteria (27 listed)
- Clinically significant cardiac valve regurgitation (≥ mild severity)
- Respiratory diseases: acute or chronic respiratory disorders
- Endocrine diseases: thyroid disease, diabetes mellitus, hyperaldosteronism, pheochromocytoma, etc.
- Abnormal liver function (alanine transaminase > 2× upper limit of normal), abnormal renal function (elevated creatinine beyond normal range), or dyslipidemia (elevated triglycerides, total cholesterol, low-density lipoprotein, or high-density lipoprotein)
- Other systemic diseases: anemia, malignancy, connective tissue disease, large artery/peripheral vascular diseases (aortic dilation, aortic dissection, coarctation of the aorta, Takayasu arteritis, atherosclerosis), etc.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Right Atrioventricular Coupling Index (RACI)
Time frame: At study enrollment (baseline)
RACI links the volumes of the right atrium (RA) and right ventricle (RV), with the degree of their volume matching reflecting their synergistic functional status during hemodynamic regulation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2025.
- Individual participant dataSharing planned: No
Related trials for Healthy Adults
RecruitingPhase 1
A Single Ascending Dose Study of DTI-117 Given Intramuscularly in Healthy Participants.
Healthy Adult
RecruitingPhase 1
mRNA Vaccine Targeting Epstein-Barr Virus (EBV) in Healthy Young Adults
EBV
Active, not recruitingPhase 1/2
Safety and Immunogenicity Study of SCB-1022 and SCB-1033 in Healthy Older Adults
RSV Infection, Human Metapneumovirus Infection
Recruiting
Effects of Urolithin A Supplementation on Glucose Metabolism in Healthy Adults 55 >= Years Old: A Randomized Triple-Masked Controlled Clinical Trial
Healthy Volunteer
Not yet recruiting
Performance Evaluation of the OCUTOP Hand-held Corneal Topographer
Corneal Topography, Dry Eye Syndromes
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.
Chunyan Ma, MD principal investigator
First Hospital of China Medical University
25 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy Adults and Pulmonary Hypertension, run by First Hospital of China Medical University at 25 sites 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 23 inclusion and 27 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: opening soon, as of the sponsor's last update on 18 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 25 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Chunyan Ma, MD (+86 13998816448, mcy_echo@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Right Atrioventricular Coupling Index (RACI) (time frame: At study enrollment (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 18 Dec 2025.