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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
Sponsor:
Information provided by (Responsible Party):
Zoran Popovic, The Cleveland Clinic

December 26, 2007
January 10, 2008
April 20, 2017
February 5, 2018
February 5, 2018
June 2005
April 2008   (Final data collection date for primary outcome measure)
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.
Myocardial torsion as measured by tissue Doppler echocardiography [ Time Frame: 1 1/2 hours ]
Complete list of historical versions of study NCT00589836 on ClinicalTrials.gov Archive Site
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Assessment of Left Ventricular Torsion by Echocardiography Study
Assessment of LV Torsion by Tissue Doppler Echocardiography
The purpose of this study is to learn about the twisting or wringing motion of the heartbeat called Left Ventricular Torsion (LV Torsion) which can be seen on ultrasound.

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.

Observational
Observational Model: Case-Control
Time Perspective: Cross-Sectional
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Non-Probability Sample
Patients undergoing cardiac echocardiography testing in the outpatient department
Hypertrophic Cardiomyopathy
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Cardiac Pathologies
Patients with cardiomyopathy, ischemic heart disease, will have tissue Doppler echocardiograms performed
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
20
40
April 2008
April 2008   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
Sexes Eligible for Study: All
18 Years to 70 Years   (Adult, Older Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00589836
IRB 05-023
No
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Plan to Share IPD: No
Zoran Popovic, The Cleveland Clinic
The Cleveland Clinic
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Principal Investigator: Zoran Popovic, M.D. The Cleveland Clinic
The Cleveland Clinic
July 2017