NCT00589836

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jun 2005

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2005

Completed
2.6 years until next milestone

First Submitted

Initial submission to the registry

December 26, 2007

Completed
15 days until next milestone

First Posted

Study publicly available on registry

January 10, 2008

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2008

Completed
9.9 years until next milestone

Results Posted

Study results publicly available

February 5, 2018

Completed
Last Updated

February 5, 2018

Status Verified

July 1, 2017

Enrollment Period

2.8 years

First QC Date

December 26, 2007

Results QC Date

April 20, 2017

Last Update Submit

July 19, 2017

Conditions

Keywords

HCMHOCMhypertrophic cardiomyopathytissue doppler echocardiographymyocardial torsion

Outcome Measures

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.

    1 1/2 hours

Study Arms (1)

Cardiac Pathologies

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

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients undergoing cardiac echocardiography testing in the outpatient department

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Location

MeSH Terms

Conditions

Cardiomyopathy, Hypertrophic

Condition Hierarchy (Ancestors)

CardiomyopathiesHeart DiseasesCardiovascular DiseasesAortic Stenosis, SubvalvularAortic Valve StenosisAortic Valve DiseaseHeart Valve Diseases

Results Point of Contact

Title
Zoran Popovic MD
Organization
Cleveland Clinic

Study Officials

  • Zoran Popovic, M.D.

    The Cleveland Clinic

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 26, 2007

First Posted

January 10, 2008

Study Start

June 1, 2005

Primary Completion

April 1, 2008

Study Completion

April 1, 2008

Last Updated

February 5, 2018

Results First Posted

February 5, 2018

Record last verified: 2017-07

Data Sharing

IPD Sharing
Will not share

Locations