- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04959357
The Evaluation of Left Ventricular Systolic Function in Different Types of Ischemic Heart Disease
July 12, 2021 updated by: Peking University Third Hospital
The Evaluation of Left Ventricular Systolic Function in Different Types of Ischemic Heart Disease by Two-dimensional Speckle-tracking Echocardiography
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.
Study Overview
Status
Completed
Intervention / Treatment
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.
Study Type
Observational
Enrollment (Actual)
242
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Beijing
-
Beijing, Beijing, China, 100191
- Department of Cardiology, Peking University Third Hospital, NHC Key Laboratory of Cardiovascular Molecular Biology and Regulatory Peptides
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 85 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
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.
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
control group
|
lobal longitudinal strain and strain rate, subendocardial LS and subepicardial LS were quantified by two dimensional speckle tracking imaging
|
coronary microvascular dysfunction group
|
lobal longitudinal strain and strain rate, subendocardial LS and subepicardial LS were quantified by two dimensional speckle tracking imaging
|
obstructive coronary artery disease
|
lobal longitudinal strain and strain rate, subendocardial LS and subepicardial LS were quantified by two dimensional speckle tracking imaging
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
global longitudinal strain
Time Frame: 15/3/2018-30/12/2018
|
global longitudinal strain of CMD group and obstructive CAD group
|
15/3/2018-30/12/2018
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Li Zhaoping, professor, Peking University Third Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
March 15, 2018
Primary Completion (ACTUAL)
October 30, 2018
Study Completion (ACTUAL)
December 30, 2018
Study Registration Dates
First Submitted
June 27, 2021
First Submitted That Met QC Criteria
July 12, 2021
First Posted (ACTUAL)
July 13, 2021
Study Record Updates
Last Update Posted (ACTUAL)
July 13, 2021
Last Update Submitted That Met QC Criteria
July 12, 2021
Last Verified
July 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 048-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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