Study on the Value of Three-dimensional Speckle Tracking Technique

NCT03905200 | Unknown FDA Device

• 1 other identifier: Z161100000516053
• Study Type: observational
• Target: 800
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Echocardiography, Three-Dimensional; Coronary Artery Disease

Outcome Measures

Primary Outcomes (1)

• 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

  half an hour

Secondary Outcomes (1)

• The value of 3D-STI technology on the improvement of left ventricular myocardial function

  half a year

Study Arms (1)

coronary artery disease

Patients who were diagnosed with coronary heart disease at admission and planned to undergo coronary angiography

Diagnostic Test: 3D-speckle tracking imaging

Interventions

3D-speckle tracking imaging DIAGNOSTIC_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.

coronary artery disease

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

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.

You may qualify if:

• patients diagnosed with coronary heart disease
• patients underwent coronary angiography with or without PCI

You may not qualify if:

• 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

Sponsors & Collaborators

• Beijing Hospital: lead

Study Sites (1)

Beijing Hospital

Beijing, Beijing Municipality, 100730, China

RECRUITING

Related Publications (4)

• 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.

  PMID: 41455557 DERIVED

• Guo 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.

  PMID: 40787200 DERIVED

• Guo 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.

  PMID: 37170232 DERIVED

• Guo 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.

  PMID: 36899310 DERIVED

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 31, 2019
• First Posted: April 5, 2019
• Study Start: March 1, 2019
• Primary Completion: May 31, 2020
• Study Completion: December 31, 2020
• Last Updated: April 5, 2019

Record last verified: 2019-04

Locations

CN (1)