Study on the Value of Three-dimensional Speckle Tracking Technique

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.

Study Overview

• Status: Unknown
• Conditions: Coronary Artery Disease; Echocardiography, Three-Dimensional
• Intervention / Treatment: Diagnostic test: 3D-speckle tracking imaging

• Study Type: Observational
• Enrollment (Anticipated): 800

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100730
      • Recruiting
      • Beijing Hospital
      • Contact: Xin Wang, Dotoral; Phone Number: 86 10 58115037; Email: bjyygcp@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Beijing Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2019
• Primary Completion (Anticipated): May 31, 2020
• Study Completion (Anticipated): December 31, 2020

Study Registration Dates

• First Submitted: March 31, 2019
• First Submitted That Met QC Criteria: April 4, 2019
• First Posted (Actual): April 5, 2019

Study Record Updates

• Last Update Posted (Actual): April 5, 2019
• Last Update Submitted That Met QC Criteria: April 4, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Coronary Artery Disease
• Other Study ID Numbers: Z161100000516053

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes