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

December 26, 2007
October 22, 2008
June 2005
December 2008   (final data collection date for primary outcome measure)
Myocardial torsion as measured by tissue Doppler echocardiography [ Time Frame: 1 1/2 hours ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00589836 on ClinicalTrials.gov Archive Site
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Assessment of Left Ventricular Torsion by Echocardiography Study
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 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.

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.

Observational
Observational Model: Case Control
Time Perspective: Cross-Sectional
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Non-Probability Sample

Patients undergoing cardiac echocardiography testing in the outpatient department

Hypertrophic Cardiomyopathy
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  • Normal
    Patients with structurally normal hearts
  • HCM
    Patients with hypertrophic cardiomyopathy
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
40
December 2008
December 2008   (final data collection date for primary outcome measure)

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
Both
18 Years to 70 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00589836
IRB 05-023
No
Zoran Popovic, PhD, Cleveland Clinic
The Cleveland Clinic
Not Provided
Principal Investigator: Zoran Popovic, M.D. The Cleveland Clinic
The Cleveland Clinic
June 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP