Assessment of Left Ventricular Torsion by Echocardiography Study (LVTorsion)
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|ClinicalTrials.gov Identifier: NCT00589836|
Recruitment Status : Completed
First Posted : January 10, 2008
Results First Posted : February 5, 2018
Last Update Posted : February 5, 2018
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|Condition or disease|
This study is designed to characterize the myocardial torsional behavior in patients with a variety of cardiac pathologies.
Simple and inexpensive methods for measurement of LV torsion could facilitate more widespread investigation of LV torsion, which might reveal significant relationships between torsional alterations and clinical outcomes and eventually lead to routine clinical application. Recently, Doppler tissue imaging (DTI) has been shown to accurately reflect myocardial velocity24,25 with better temporal resolution than MRI.26 Investigators hypothesize therefore that DTI might be used for quantification of LV rotation and torsion of the human heart. The purpose of the present study was to examine the accuracy of a novel method with DTI for quantifying the LV torsion in humans and tagged MRI as the reference standard.
|Study Type :||Observational|
|Actual Enrollment :||20 participants|
|Official Title:||Assessment of LV Torsion by Tissue Doppler Echocardiography|
|Study Start Date :||June 2005|
|Actual Primary Completion Date :||April 2008|
|Actual Study Completion Date :||April 2008|
Patients with cardiomyopathy, ischemic heart disease, will have tissue Doppler echocardiograms performed
- Accuracy of Doppler Tissue Imaging [ Time Frame: 1 1/2 hours ]
The purpose of the present study was to examine the accuracy of a novel method with DTI for quantifying the LV torsion in humans and tagged MRI as the reference standard.
LV torsion reflects the torsion (twisting deformation) occurring across the length of the ventricle (from the base to the apex) during the time interval defined by the beginning and end of contraction (or in physiologic terms, from end -diastole to end systole). In this study, end diastole was defined by the R wave of the ECG, while end systole is defined by minimum end-systolic volume or maximum of twisting deformation. The deformation is measured in degrees.
Once the measurements are performed by experimental method (i.e. TDI imaging) and reference method (i.e. MRI imaging) these two methods are then compared using Bland Altman analysis.
In a current study, mean difference between methods of torsion quantification was 0.57 degrees, while the standard deviation (SD) was 1.98 degrees.
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|Ages Eligible for Study:||18 Years to 70 Years (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||Yes|
|Sampling Method:||Non-Probability Sample|
- Male and female patients age 18 to 70 years
- Patients with hypertrophic cardiomyopathy
- Patients with the ability to exercise using a supine bicycle
- Ability to provide informed consent
- Aortic valve stenosis classified as moderate to severe
- Severe left ventricular obstruction at rest (high gradients > 4m/second)
- Uncontrolled arrhythmias including atrial fibrillation, atrial flutter, frequent premature ventricular ectopic beats
- History of sustained ventricular tachyarrhythmia at any time
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): NCT00589836
|United States, Ohio|
|The Cleveland Clinic Foundation|
|Cleveland, Ohio, United States, 44195|
|Principal Investigator:||Zoran Popovic, M.D.||The Cleveland Clinic|
|Responsible Party:||Zoran Popovic, Principal Investigator, The Cleveland Clinic|
|Other Study ID Numbers:||
|First Posted:||January 10, 2008 Key Record Dates|
|Results First Posted:||February 5, 2018|
|Last Update Posted:||February 5, 2018|
|Last Verified:||July 2017|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|
tissue doppler echocardiography
Pathological Conditions, Anatomical
Aortic Stenosis, Subvalvular
Aortic Valve Stenosis
Aortic Valve Disease
Heart Valve Diseases