Expired Study
This study is not currently recruiting Study Participants on ClinicalConnection.com. If you would like to find active studies please search for clinical trials.

Cleveland, Ohio 44195


Purpose:

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 summary:

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.


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


Study is Available At:


Original ID:

IRB 05-023


NCT ID:

NCT00589836


Secondary ID:


Study Acronym:

LVTorsion


Brief Title:

Assessment of Left Ventricular Torsion by Echocardiography Study


Official Title:

Assessment of LV Torsion by Tissue Doppler Echocardiography


Overall Status:

Completed


Study Phase:

N/A


Genders:

N/A


Minimum Age:

18 Years


Maximum Age:

70 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

The Cleveland Clinic


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:


Study Type:

Observational


Study Design:


Number of Arms:

0


Number of Groups:

1


Total Enrollment:

20


Enrollment Type:

Actual


Overall Contact Information

Official Name:Zoran Popovic, M.D.
Principal Investigator
The Cleveland Clinic

Study Dates

Start Date:June 2005
Completion Date:April 2008
Completion Type:Actual
Primary Completion Date:April 2008
Primary Completion Type:Actual
Verification Date:July 2017
Last Changed Date:July 19, 2017
First Received Date:December 26, 2007
First Results Date:April 20, 2017

Study Outcomes

Outcome Type:Primary Outcome
Measure:Accuracy of Doppler Tissue Imaging
Time Frame:1 1/2 hours
Safety Issues:False
Description: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

Study Interventions

There are no available Study Interventions

Study Arms

Study Arm Type:Other
Arm Name:Cardiac Pathologies
Description:Patients with cardiomyopathy, ischemic heart disease, will have tissue Doppler echocardiograms performed

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:The Cleveland Clinic

Samples and Retentions

Study Population: Patients undergoing cardiac echocardiography testing in the outpatient department
Sample Method:Non-Probability Sample

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

Modifications to this listing: Only selected fields are shown, please use the link below to view all information about this clinical trial.


This study is not currently recruiting Study Participants. The form below is not enabled.