CClinicalTrials.gg
CompletedNCT00589836LVTorsionUpdated Feb 5, 2018Results posted

Assessment of Left Ventricular Torsion by Echocardiography Study

An observational study in Hypertrophic Cardiomyopathy, sponsored by The Cleveland Clinic. Completed at 1 site in United States. Open to participants aged 18 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-02-05.

Sponsored by The Cleveland Clinic · Observational

Study type
Observational
Model
Case-control
Time perspective
Cross-sectional
Enrollment
20
Ages
18 Years to 70 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Hypertrophic Cardiomyopathy

Keywords

  • HCM
  • HOCM
  • hypertrophic cardiomyopathy
  • tissue doppler echocardiography
  • myocardial torsion
03

In context

Cardiomyopathies

1,176 studies on the registry are indexed under Cardiomyopathies; 287 are open to participants now.

This study's enrollment of 20 is below the median of 153 across 515 observational studies indexed under Cardiomyopathies.

Browse Cardiomyopathies studies →

Lead sponsor

The Cleveland Clinic is the lead sponsor of 818 studies on the registry; 118 are open to participants now.

Of its 89 completed or terminated interventional studies of FDA-regulated products, 72 (81%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Patients undergoing cardiac echocardiography testing in the outpatient department

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

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
05

Study design

Observational model
Case-control
Time perspective
Cross-sectional
Enrollment
20 participants (actual)

Groups and cohorts

  • Cardiac Pathologies

    Patients with cardiomyopathy, ischemic heart disease, will have tissue Doppler echocardiograms performed

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 1 1/2 hours

07

Results

Posted Feb 5, 2018

Participant flow

Participant flow — Overall Study
MilestoneCardiac Pathologies
Started20
Completed20
Not completed0

Outcome measures

PrimaryAccuracy 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.

Time frame:
1 1/2 hours
Reported as:
Mean · degrees
Accuracy of Doppler Tissue Imaging
degreesCardiac Pathologies
Accuracy of Doppler Tissue Imaging0.57 ± 1.98

Adverse events

Collected over 1.5 Hours. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Cardiac Pathologies0/20 (0%)0/20 (0%)0/20 (0%)

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)Cardiac Pathologies
<=18 years0
Between 18 and 65 years12
>=65 years8
Sex: Female, Male
Sex: Female, Male(Participants)Cardiac Pathologies
Female3
Male17
08

Study locations

1 site
  • The Cleveland Clinic Foundation
    Cleveland, Ohio 44195, United States
09

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 5, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT00589836
Lead sponsor
The Cleveland Clinic
Responsible party
Zoran Popovic (Principal Investigator, The Cleveland Clinic) — Principal investigator
First posted
Jan 10, 2008
Start date
Jun 2005
Primary completion
Apr 2008
Completion
Apr 2008
Results posted
Feb 5, 2018
Last update
Feb 5, 2018

Study contacts

Zoran Popovic, M.D.
principal investigator · The Cleveland Clinic

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2017. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion