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Assessment of Left Ventricular Torsion by Echocardiography Study (LVTorsion)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2008 by The Cleveland Clinic.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
The Cleveland Clinic
ClinicalTrials.gov Identifier:
NCT00589836
First received: December 26, 2007
Last updated: October 22, 2008
Last verified: June 2008
History of Changes
  Purpose

The purpose of this study is to learn about the twisting or wringing motion of the heartbeat called torsion which can be seen on ultrasound. This study will help figure out if there is a difference in the how a heart twists at rest and with exercise in people with normal hearts compared to people with HCM (abnormally thickened heart muscle). Volunteers will have an echocardiogram (ultrasound of the heart) while lying on a bed both at rest and while peddling a wheel located at at the foot of the bed. The patients will take about 1 to 1 1/2 hours total and the study will be complete after this procedure.


Condition
Hypertrophic Cardiomyopathy

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: Assessment of LV Torsion by Tissue Doppler Echocardiography

Resource links provided by NLM:

MedlinePlus related topics: Cardiomyopathy
U.S. FDA Resources

Further study details as provided by The Cleveland Clinic:

Primary Outcome Measures:
  • Myocardial torsion as measured by tissue Doppler echocardiography [ Time Frame: 1 1/2 hours ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: June 2005
Estimated Study Completion Date: December 2008
Estimated Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Groups/Cohorts
Normal
Patients with structurally normal hearts
HCM
Patients with hypertrophic cardiomyopathy

Detailed Description:

Left ventricular myocardial torsion (myocardial wringing motion) will be investigated by the use of tissue Doppler echocardiography in both normal and HCM (hypertrophic cardiomyopathy) patients. The objective of this study is to characterize the myocardial torsional behavior in normal and in HCM patients both at rest and while undergoing moderate physiological exercise.

After a routine echocardiographic study, tissue Doppler echocardiogram will be performed before and during supine bicycle exercise. Stress EchoTM Bed with ergometer (supine bicycle) is used during exercise testing. Standard electrocardiogram and blood pressure will be monitored throughout the exercise testing. This procedure will take about 1 to 1 1/2 hours and will not involve any follow-up.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Zoran Popovic, PhD, Cleveland Clinic
ClinicalTrials.gov Identifier: NCT00589836     History of Changes
Other Study ID Numbers: IRB 05-023
Study First Received: December 26, 2007
Last Updated: October 22, 2008
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on May 19, 2013