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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

Study Type Observational
Study Design Observational Model: Case-Control;   Time Perspective: Cross-Sectional
Condition Hypertrophic Cardiomyopathy
Enrollment 20
Recruitment Details  
Pre-assignment Details Consecutive patients with clinically indicated MRI and previous satisfactory echocardiographic images on a previously performed study had a research echocardiographic study on the same day as the MRI
Arm/Group Title Cardiac Pathologies
Hide Arm/Group Description Clinical diagnosis included aortic root disorder, severe aortic insufficiency, severe aortic stenosis, post aortic valve replacement, and cardiomyopathies.
Period Title: Overall Study
Started 20
Completed 20
Not Completed 0
Arm/Group Title Cardiac Pathologies
Hide Arm/Group Description Patients with cardiac pathologies of aortic root disorder, severe aortic stenosis, severe aortic insufficiency, aortic valve replacement, ischemic heart disease and cardiomyopathies had tissue DTI and MRI performed
Overall Number of Baseline Participants 20
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants
<=18 years 0
Between 18 and 65 years 12
>=65 years 8
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants
Female
3
  15.0%
Male
17
  85.0%
1.Primary Outcome
Title Accuracy of Doppler Tissue Imaging
Hide Description

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.

Time Frame 1 1/2 hours
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
population had both MRI and DTI on the same day.
Arm/Group Title Cardiac Pathologies
Hide Arm/Group Description:
Clinical diagnosis included aortic root disorder, severe aortic insufficiency, severe aortic stenosis, post aortic valve replacement, and cardiomyopathies.
Overall Number of Participants Analyzed 20
Mean (Standard Deviation)
Unit of Measure: degrees
0.57  (1.98)
Time Frame 1.5 Hours
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Cardiac Pathologies
Hide Arm/Group Description Clinical diagnosis included aortic root disorder, severe aortic insufficiency, severe aortic stenosis, post aortic valve replacement, and cardiomyopathies.
All-Cause Mortality
Cardiac Pathologies
Affected / at Risk (%)
Total   0/20 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Cardiac Pathologies
Affected / at Risk (%)
Total   0/20 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Cardiac Pathologies
Affected / at Risk (%)
Total   0/20 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Zoran Popovic MD
Organization: Cleveland Clinic
Phone: 216 444-9242
Responsible Party: Zoran Popovic, The Cleveland Clinic
ClinicalTrials.gov Identifier: NCT00589836     History of Changes
Other Study ID Numbers: IRB 05-023
First Submitted: December 26, 2007
First Posted: January 10, 2008
Results First Submitted: April 20, 2017
Results First Posted: February 5, 2018
Last Update Posted: February 5, 2018