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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04959357
Other study ID # 048-01
Secondary ID
Status Completed
Phase
First received
Last updated
Start date March 15, 2018
Est. completion date December 30, 2018

Study information

Verified date July 2021
Source Peking University Third Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 242
Est. completion date December 30, 2018
Est. primary completion date October 30, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years to 85 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
China Department of Cardiology, Peking University Third Hospital, NHC Key Laboratory of Cardiovascular Molecular Biology and Regulatory Peptides Beijing Beijing

Sponsors (1)

Lead Sponsor Collaborator
Peking University Third Hospital

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary global longitudinal strain global longitudinal strain of CMD group and obstructive CAD group 15/3/2018-30/12/2018
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