Assessment of Left Ventricular Torsion by Echocardiography Study (LVTorsion)

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.

Study Overview

• Status: Completed
• Conditions: 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
• Enrollment (Actual): 20

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • The Cleveland Clinic Foundation

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing cardiac echocardiography testing in the outpatient department

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Accuracy of Doppler Tissue Imaging	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.	1 1/2 hours

Collaborators and Investigators

• Sponsor: The Cleveland Clinic
• Investigators: Principal Investigator: Zoran Popovic, M.D., The Cleveland Clinic

Study record dates

Study Major Dates

• Study Start: June 1, 2005
• Primary Completion (Actual): April 1, 2008
• Study Completion (Actual): April 1, 2008

Study Registration Dates

• First Submitted: December 26, 2007
• First Submitted That Met QC Criteria: January 9, 2008
• First Posted (Estimate): January 10, 2008

Study Record Updates

• Last Update Posted (Actual): February 5, 2018
• Last Update Submitted That Met QC Criteria: July 19, 2017
• Last Verified: July 1, 2017

More Information

Terms related to this study

• Keywords: HOCM; HCM; hypertrophic cardiomyopathy; tissue doppler echocardiography; myocardial torsion
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Pathological Conditions, Anatomical; Aortic Valve Disease; Heart Valve Diseases; Aortic Stenosis, Subvalvular; Aortic Valve Stenosis; Hypertrophy; Cardiomyopathies; Cardiomyopathy, Hypertrophic
• Other Study ID Numbers: IRB 05-023

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
• Studies a U.S. FDA-regulated device product: No