Echocardiography, Three-DimensionalNCT03905200
Study on the Value of Three-dimensional Speckle Tracking Technique
An observational study of Echocardiography, Three-Dimensional and Coronary Artery Disease, run by Beijing Hospital at 1 site in China.
Trial summary
For a long time, it has been hoped that doctors could screen and diagnosis of coronary heart disease through non-invasive imaging techniques, so as to maximize the benefit/risk ratio of patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Echocardiography, Three-Dimensional, Coronary Artery Disease
- What is being tested?
- 3D-speckle tracking imaging
- How many people
- 800 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2019to 31 Dec 2020
- 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
- No healthy volunteers
- Adult, Older adult
Study population: According to reference, the area under the ROC curve of 3d-STI strain peak and strain peaking time for the diagnosis of coronary heart disease is about 0.65.In this study, it is expected that the combined diagnosis model can increase the area under the ROC curve to the level of 0.85, and the standard deviation of the area under the ROC curve is estimated to be 0.5. In order to get 85% assurance, we plan to include 827 subjects.
Who may be able to join
- patients diagnosed with coronary heart disease
- patients underwent coronary angiography with or without PCI
Who cannot join
- patients with non-sinus rhythm
- patients with severe heart valvular disease
- patients with severe cardiomyopathy
- patients with congenital heart disease
- patients with severe heart failure stage
- patients with acute myocardial infarction occurred during follow-up
- patients with other extremely severe illness
- patients whose images are not clear enough to mark the endocardium
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Beijing Hospital
Beijing, Beijing Municipality, 100730
Xin Wang, Dotoral, 86 10 58115037, bjyygcp@126.com
About this study
Official title: Study on the Value of Three-dimensional Speckle Tracking Technique in the Diagnosis and Follow-up of Coronary Heart Disease
For a long time, it has been hoped that doctors could screen and diagnosis of coronary heart disease through non-invasive imaging techniques, so as to maximize the benefit/risk ratio of patients. This trial is to explore the screening and diagnostic value of three-dimensional speckle tracking technology for coronary heart disease, and the evaluation value of 3D speckle track image(3D-STI) technology for cardiac function improvement after coronary intervention, and to seek reliable, accurate and quantifiable non-invasive imaging examination for the diagnosis, follow-up and prognosis of coronary heart disease.
In this study, coronary angiography is taken as the "gold standard", and 3d-STI echocardiography technology is proposed to combine with clinical characteristics of subjects for joint diagnosis, so as to evaluate the value of 3d-sti technology in the diagnosis of coronary heart disease.
Patients were followed up with echocardiography after interventional treatment to explore the feasibility of 3D-STI technology in evaluating cardiac function improvement.
- Being tested
- 3D-speckle tracking imaging
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3D-speckle tracking imagingDiagnostic test
The strain peak value and strain peaking time of each segment (including 16 segments) of the left ventricular myocardium can be obtained by 3d-sti technology.
| Study group | Role | What they receive |
|---|---|---|
| coronary artery disease | Patients who were diagnosed with coronary heart disease at admission and planned to undergo coronary angiography Receives: Diagnostic Test: 3D-speckle tracking imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Left ventricular myocardial viability
By measuring the strain and time to peak, the left ventricular myocardial viability was finally evaluated. Left ventricular local ventricular viable myocardium was quantitatively analyzed in patients .Aimed to detect the myocardial ischaemia and viability. The data of strain and time to peak were measured using the three-dimensional speckle tracking model.
In apical four-chamber view, make sure the endocardium, mitral valve ring and apex imaging is clear, mark the left and right mitral valve ring and apex spot . After automatic ultrasonic echo spot tracked, software can delineate endocardial curve, and automaticaly calculate the left ventricular myocardial segments strain and time to peak.
The strain peaks of each segment (including 16 segments) of the myocardium of the left ventricle included four strain peaks: RS, CS, LS and AS
Measured: half an hour
Secondary outcomes (1)
The value of 3D-STI technology on the improvement of left ventricular myocardial function
During the 6-month follow-up, 3D-STI technique was used to evaluate the improvement of left ventricular myocardial function compared with conventional parameters like LVEF and NYHA. 3D-STI parameters are the same : strain and peak time .
Measured: half a year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2019
- Study start1 Mar 2019
- Primary completion31 May 2020 (estimated)
- Study completion31 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Echocardiography, Three-DimensionalStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Fang Wang, Beijing Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03905200
- Sponsor's protocol ID
- Z161100000516053
- Status last verified
- Apr 2019
- First submitted
- 31 Mar 2019
- Last updated
- 5 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Publications
Guo Y, Song X, Xu T, Guo H, Yang C, Zhong Y, Li H, Gong J, Wang F. Utilizing machine learning in echocardiographic analysis to distinguish obstructive and non-obstructive coronary artery disease. Int J Cardiol. 2026 Mar 15;447:134121. doi: 10.1016/j.ijcard.2025.134121. Epub 2025 Dec 25.
PubMed 41455557Guo Y, Cai YH, Xu T, Song XY, Guo HX, Dong M, Ni D, Li H, Wang F, Xue WF. Echocardiographic video-driven multi-task learning model for coronary artery disease diagnosis and severity grading. Front Bioeng Biotechnol. 2025 Jul 25;13:1556748. doi: 10.3389/fbioe.2025.1556748. eCollection 2025.
PubMed 40787200Guo Y, Xia C, Zhong Y, Wei Y, Zhu H, Ma J, Li G, Meng X, Yang C, Wang X, Wang F. Machine learning-enhanced echocardiography for screening coronary artery disease. Biomed Eng Online. 2023 May 11;22(1):44. doi: 10.1186/s12938-023-01106-x.
PubMed 37170232Guo Y, Wang X, Yang CG, Meng XY, Li Y, Xia CX, Xu T, Weng SX, Zhong Y, Zhang RS, Wang F. Noninvasive assessment of myocardial work during left ventricular isovolumic relaxation in patients with diastolic dysfunction. BMC Cardiovasc Disord. 2023 Mar 10;23(1):129. doi: 10.1186/s12872-023-03156-4.
PubMed 36899310
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on the Value of Three-dimensional Speckle Tracking Technique in the Diagnosis and Follow-up of Coronary Heart Disease
- ClinicalTrials.gov ID
- NCT03905200
- Acronym / sponsor ID
- Z161100000516053
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- Beijing HospitalOther government
- Study start
- 1 Mar 2019 (actual)
- Primary completion
- 31 May 2020 (estimated)
- Study completion
- 31 Dec 2020 (estimated)
- First posted
- 5 Apr 2019 (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.
For a long time, it has been hoped that doctors could screen and diagnosis of coronary heart disease through non-invasive imaging techniques, so as to maximize the benefit/risk ratio of patients. This trial is to explore the screening and diagnostic value of three-dimensional speckle tracking technology for coronary heart disease, and the evaluation value of 3D speckle track image(3D-STI) technology for cardiac function improvement after coronary intervention, and to seek reliable, accurate and quantifiable non-invasive imaging examination for the diagnosis, follow-up and prognosis of coronary heart disease.
In this study, coronary angiography is taken as the "gold standard", and 3d-STI echocardiography technology is proposed to combine with clinical characteristics of subjects for joint diagnosis, so as to evaluate the value of 3d-sti technology in the diagnosis of coronary heart disease.
Patients were followed up with echocardiography after interventional treatment to explore the feasibility of 3D-STI technology in evaluating cardiac function improvement.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| coronary artery disease | – | Diagnostic Test: 3D-speckle tracking imagingPatients who were diagnosed with coronary heart disease at admission and planned to undergo coronary angiography |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- According to reference, the area under the ROC curve of 3d-STI strain peak and strain peaking time for the diagnosis of coronary heart disease is about 0.65.In this study, it is expected that the combined diagnosis model can increase the area under the ROC curve to the level of 0.85, and the standard deviation of the area under the ROC curve is estimated to be 0.5. In order to get 85% assurance, we plan to include 827 subjects.
Key inclusion criteria (2 listed)
- patients diagnosed with coronary heart disease
- patients underwent coronary angiography with or without PCI
Key exclusion criteria (8 listed)
- patients with non-sinus rhythm
- patients with severe heart valvular disease
- patients with severe cardiomyopathy
- patients with congenital heart disease
- patients with severe heart failure stage
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 |
|---|---|---|
| 3D-speckle tracking imagingThe strain peak value and strain peaking time of each segment (including 16 segments) of the left ventricular myocardium can be obtained by 3d-sti technology. | Diagnostic test | coronary artery disease |
Primary outcome
Left ventricular myocardial viability
Time frame: half an hour
By measuring the strain and time to peak, the left ventricular myocardial viability was finally evaluated. Left ventricular local ventricular viable myocardium was quantitatively analyzed in patients .Aimed to detect the myocardial ischaemia and viability. The data of strain and time to peak were measured using the three-dimensional speckle tracking model. In apical four-chamber view, make sure the endocardium, mitral valve ring and apex imaging is clear, mark the left and right mitral valve ring and apex spot . After automatic ultrasonic echo spot tracked, software can delineate endocardial curve, and automaticaly calculate the left ventricular myocardial segments strain and time to peak. The strain peaks of each segment (including 16 segments) of the myocardium of the left ventricle included four strain peaks: RS, CS, LS and AS
1 secondary outcome
The value of 3D-STI technology on the improvement of left ventricular myocardial function
Time frame: half a year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2019.
- Derived from this study: PubMed 41455557Guo Y, Song X, Xu T, Guo H, Yang C, Zhong Y, Li H, Gong J, Wang F. Utilizing machine learning in echocardiographic analysis to distinguish obstructive and non-obstructive coronary artery disease. Int J Cardiol. 2026 Mar 15;447:134121. doi: 10.1016/j.ijcard.2025.134121. Epub 2025 Dec 25.
- Derived from this study: PubMed 40787200Guo Y, Cai YH, Xu T, Song XY, Guo HX, Dong M, Ni D, Li H, Wang F, Xue WF. Echocardiographic video-driven multi-task learning model for coronary artery disease diagnosis and severity grading. Front Bioeng Biotechnol. 2025 Jul 25;13:1556748. doi: 10.3389/fbioe.2025.1556748. eCollection 2025.
- Derived from this study: PubMed 37170232Guo Y, Xia C, Zhong Y, Wei Y, Zhu H, Ma J, Li G, Meng X, Yang C, Wang X, Wang F. Machine learning-enhanced echocardiography for screening coronary artery disease. Biomed Eng Online. 2023 May 11;22(1):44. doi: 10.1186/s12938-023-01106-x.
- Derived from this study: PubMed 36899310Guo Y, Wang X, Yang CG, Meng XY, Li Y, Xia CX, Xu T, Weng SX, Zhong Y, Zhang RS, Wang F. Noninvasive assessment of myocardial work during left ventricular isovolumic relaxation in patients with diastolic dysfunction. BMC Cardiovasc Disord. 2023 Mar 10;23(1):129. doi: 10.1186/s12872-023-03156-4.
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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.
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 Echocardiography, Three-Dimensional and Coronary Artery Disease, run by Beijing Hospital 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 8 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: status not confirmed, as of the sponsor's last update on 5 Apr 2019. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Left ventricular myocardial viability (time frame: half an hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03905200, which also lists 4 linked publications.
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 5 Apr 2019.