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Study on the Value of Three-dimensional Speckle Tracking Technique

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ClinicalTrials.gov Identifier: NCT03905200
Recruitment Status : Recruiting
First Posted : April 5, 2019
Last Update Posted : April 5, 2019
Sponsor:
Information provided by (Responsible Party):
Fang Wang, Beijing Hospital

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.


Condition or disease Intervention/treatment
Echocardiography, Three-Dimensional Coronary Artery Disease Diagnostic Test: 3D-speckle tracking imaging

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Study Type : Observational
Estimated Enrollment : 800 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Study on the Value of Three-dimensional Speckle Tracking Technique in the Diagnosis and Follow-up of Coronary Heart Disease
Actual Study Start Date : March 1, 2019
Estimated Primary Completion Date : May 31, 2020
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. 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



Secondary Outcome Measures :
  1. The value of 3D-STI technology on the improvement of left ventricular myocardial function [ Time Frame: half a year ]
    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 .



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03905200


Locations
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China, Beijing
Beijing Hospital Recruiting
Beijing, Beijing, China, 100730
Contact: Xin Wang, Dotoral    86 10 58115037    bjyygcp@126.com   
Sponsors and Collaborators
Beijing Hospital

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Responsible Party: Fang Wang, Professor, Beijing Hospital
ClinicalTrials.gov Identifier: NCT03905200     History of Changes
Other Study ID Numbers: Z161100000516053
First Posted: April 5, 2019    Key Record Dates
Last Update Posted: April 5, 2019
Last Verified: April 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Coronary Artery Disease
Coronary Disease
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases