Study on the Value of Three-dimensional Speckle Tracking Technique

Coronary Artery Disease Clinical Trial

Official title:

Study on the Value of Three-dimensional Speckle Tracking Technique in the Diagnosis and Follow-up of Coronary Heart Disease

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03905200
• Other study ID #: Z161100000516053
• Status: Recruiting
• Start date: March 1, 2019
• Est. completion date: December 31, 2020

Study information

• Verified date: April 2019
• Source: Beijing Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 800
• Est. completion date: December 31, 2020
• Est. primary completion date: May 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• patients diagnosed with coronary heart disease

• patients underwent coronary angiography with or without PCI

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Echocardiography, Three-Dimensional
• Myocardial Ischemia

Intervention

Diagnostic Test:
• 3D-speckle tracking imaging
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.

Locations

Country	Name	City	State
China	Beijing Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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 .	half a year