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The Evaluation of Left Ventricular Systolic Function in Different Types of Ischemic Heart Disease

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ClinicalTrials.gov Identifier: NCT04959357
Recruitment Status : Completed
First Posted : July 13, 2021
Last Update Posted : July 13, 2021
Sponsor:
Information provided by (Responsible Party):
Peking University Third Hospital

Brief Summary:
The study was designed to evaluate the left ventricular longitudinal strain and strain rate assessed by 2D-STI in patients with coronary microvascular dysfunction (CMD) or obstructive coronary artery disease (CAD) , to investigate the effect of different types of ischemic heart disease on the LV systolic function, and to explore the value of LS on the diagnosis of coronary microvascular dysfunction.

Condition or disease Intervention/treatment
Coronary Microvascular Dysfunction Obstructive Coronary Heart Disease Diagnostic Test: Two dimensional speckle tracking imaging

Detailed Description:
A total of 175 patients with chest pain, without wall motion abnormality and without significant coronary artery stenosis (<50%) assessed by coronary angiography or coronary computed tomography were enrolled from July 2011 to December 2017. Coronary flow reserve (CFR) of these patients were detected by transthoracic Doppler echocardiography. The patients were divided into coronary microvascular dysfunction group ( CFR≤2.5, n=67) and control group (CFR>2.5, n=108). At the same time, 67 age-matched patients with any major coronary arteries stenosis≥50% and without wall motion abnormality were involved into the obstructive coronary artery disease group. Parameters of global longitudinal strain (LS) and strain rate, subendocardial LS and subepicardial LS were quantified by 2D-STI, the differences of these parameters among three groups were analyzed,correlation analysis、univariate and multivariate analysis and receiver operating characteristic curve were used.

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Study Type : Observational
Actual Enrollment : 242 participants
Observational Model: Case-Control
Time Perspective: Retrospective
Official Title: The Evaluation of Left Ventricular Systolic Function in Different Types of Ischemic Heart Disease by Two-dimensional Speckle-tracking Echocardiography
Actual Study Start Date : March 15, 2018
Actual Primary Completion Date : October 30, 2018
Actual Study Completion Date : December 30, 2018

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
coronary microvascular dysfunction group Diagnostic Test: Two dimensional speckle tracking imaging
lobal longitudinal strain and strain rate, subendocardial LS and subepicardial LS were quantified by two dimensional speckle tracking imaging

obstructive coronary artery disease Diagnostic Test: Two dimensional speckle tracking imaging
lobal longitudinal strain and strain rate, subendocardial LS and subepicardial LS were quantified by two dimensional speckle tracking imaging

control group Diagnostic Test: Two dimensional speckle tracking imaging
lobal longitudinal strain and strain rate, subendocardial LS and subepicardial LS were quantified by two dimensional speckle tracking imaging




Primary Outcome Measures :
  1. global longitudinal strain [ Time Frame: 15/3/2018-30/12/2018 ]
    global longitudinal strain of CMD group and obstructive CAD group



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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
A total of 242 patients were enrolled, including 102 males (42.1%) and 140 females (57.9%). Their ages ranged from 44 to 81 years, with an average age of (62.6 + 8.3) years.
Criteria

Inclusion Criteria:

  • age from 18-85 years

Exclusion Criteria:

  • patients with history of myocardial infarction or abnormal wall motion suggested by conventional echocardiography
  • patients with acute heart failure, chronic heart failure or LVEF values less than 50%
  • patients with congenital heart disease, severe valvular disease, severe bradycardia, high atrioventricular block and atrial fibrillation
  • patients who did not store ultrasound images or whose ultrasound images were unclear
  • patients who had incomplete clinical data

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): NCT04959357


Locations
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China, Beijing
Department of Cardiology, Peking University Third Hospital, NHC Key Laboratory of Cardiovascular Molecular Biology and Regulatory Peptides
Beijing, Beijing, China, 100191
Sponsors and Collaborators
Peking University Third Hospital
Investigators
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Study Chair: Li Zhaoping, professor Peking University Third Hospital
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Responsible Party: Peking University Third Hospital
ClinicalTrials.gov Identifier: NCT04959357    
Other Study ID Numbers: 048-01
First Posted: July 13, 2021    Key Record Dates
Last Update Posted: July 13, 2021
Last Verified: July 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Keywords provided by Peking University Third Hospital:
two-dimensional speckle tracking imaging
strain
coronary microvascular dysfunction
Additional relevant MeSH terms:
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Heart Diseases
Coronary Disease
Coronary Artery Disease
Myocardial Ischemia
Cardiovascular Diseases
Vascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases