Trial Outcomes & Findings for Assessment of Left Ventricular Torsion by Echocardiography Study (NCT NCT00589836)

Results Overview

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.

Recruitment status

COMPLETED

Target enrollment

20 participants

Primary outcome timeframe

1 1/2 hours

Results posted on

2018-02-05

Participant Flow

Consecutive patients with clinically indicated MRI and previous satisfactory echocardiographic images on a previously performed study had a research echocardiographic study on the same day as the MRI

Participant milestones

Participant milestones
Measure	Cardiac Pathologies Clinical diagnosis included aortic root disorder, severe aortic insufficiency, severe aortic stenosis, post aortic valve replacement, and cardiomyopathies.
Overall Study STARTED	20
Overall Study COMPLETED	20
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Assessment of Left Ventricular Torsion by Echocardiography Study

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Cardiac Pathologies n=20 Participants Patients with cardiac pathologies of aortic root disorder, severe aortic stenosis, severe aortic insufficiency, aortic valve replacement, ischemic heart disease and cardiomyopathies had tissue DTI and MRI performed
Age, Categorical <=18 years	0 Participants n=99 Participants
Age, Categorical Between 18 and 65 years	12 Participants n=99 Participants
Age, Categorical >=65 years	8 Participants n=99 Participants
Sex: Female, Male Female	3 Participants n=99 Participants
Sex: Female, Male Male	17 Participants n=99 Participants

PRIMARY outcome

Timeframe: 1 1/2 hours

Population: population had both MRI and DTI on the same day.

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.

Outcome measures

Outcome measures
Measure	Cardiac Pathologies n=20 Participants Clinical diagnosis included aortic root disorder, severe aortic insufficiency, severe aortic stenosis, post aortic valve replacement, and cardiomyopathies.
Accuracy of Doppler Tissue Imaging	0.57 degrees Standard Deviation 1.98

Adverse Events

Cardiac Pathologies

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Zoran Popovic MD

Cleveland Clinic

Phone: 216 444-9242

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place