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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

Brief Summary:
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.

Condition or disease
Hypertrophic Cardiomyopathy

Detailed Description:

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
Observational Model: Case-Control
Time Perspective: Cross-Sectional
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


Group/Cohort
Cardiac Pathologies
Patients with cardiomyopathy, ischemic heart disease, will have tissue Doppler echocardiograms performed



Primary Outcome Measures :
  1. 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
Study Population
Patients undergoing cardiac echocardiography testing in the outpatient department
Criteria

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

Information from the National Library of Medicine

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


Locations
United States, Ohio
The Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195
Sponsors and Collaborators
The Cleveland Clinic
Investigators
Principal Investigator: Zoran Popovic, M.D. The Cleveland Clinic

Responsible Party: Zoran Popovic, Principal Investigator, The Cleveland Clinic
ClinicalTrials.gov Identifier: NCT00589836     History of Changes
Other Study ID Numbers: IRB 05-023
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

Keywords provided by Zoran Popovic, The Cleveland Clinic:
HCM
HOCM
hypertrophic cardiomyopathy
tissue doppler echocardiography
myocardial torsion

Additional relevant MeSH terms:
Cardiomyopathies
Hypertrophy
Cardiomyopathy, Hypertrophic
Torsion Abnormality
Heart Diseases
Cardiovascular Diseases
Pathological Conditions, Anatomical
Aortic Stenosis, Subvalvular
Aortic Valve Stenosis
Heart Valve Diseases