RF-SPEED: Radiofrequency-based Speckle Tracking Echocardiography to Evaluate Diastolic Function

• Sponsor: University of Michigan (Other)
• Overall Status: Completed
• CT.gov ID: NCT01182805
• Collaborator: Pixel Velocity, Inc. / Epsilon Imaging (Industry), National Heart, Lung, and Blood Institute (NHLBI) (NIH)
• Enrollment: 50
• Location: 1
• Arm: 1
• Duration (Months): 4
• Patients Per Site Per Month: 12.5

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate a novel ultrasound system's ability to assess the relaxing properties of the heart compared to current techniques.

Condition or Disease	Intervention/Treatment	Phase
Heart Failure, Diastolic	Device: Echocardiography system Ultra DCI Model 5000; Device: Echocardiography machine GE Vivid E9; Device: Diastolic function assessment	Phase 1/Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 50 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: Radiofrequency-based Speckle Tracking Echocardiography to Evaluate Diastolic Function
• Study Start Date: Aug 1, 2010
• Actual Primary Completion Date: Dec 1, 2010
• Actual Study Completion Date: Dec 1, 2010

Arms and Interventions

Arm

Intervention/Treatment

Other: Single arm study.

Device: Echocardiography system Ultra DCI Model 5000; Each subject will undergo scanning using the investigational echocardiography system (Ultra DCI Model 5000)to measure Diastolic Circumferential Strain Rate during Isovolumic Relaxation (DCSR-IVR) as novel measure of diastolic function.; Device: Echocardiography machine GE Vivid E9; Each subject will undergo echocardiography using a conventional echocardiography machine to evaluate the early diastolic mitral annular velocity (E-prime) using tissue Doppler as a standard measure of diastolic function.; Device: Diastolic function assessment; Each subject will undergo standard echocardiographic measure of the mitral inflow pattern and invasive catheter-derived measure of left ventricular end-diastolic pressure to determine their diastolic function. This evaluation will be used as the gold standard for this study.

Outcome Measures

Primary Outcome Measures

1. Diastolic Circumferential Strain Rate During Isovolumic Relaxation [Assessed from echo obtained at time of enrollment]

   Diastolic circumferential strain rate during isovolumic relaxation is a novel measure of diastolic function that measures the rate of relaxation of the left ventricle during the interval of isovolumic relaxation (the period of active relaxation). We would expect that a higher value reflects better relaxation, and better diastolic function.

2. Early Diastolic Mitral Annular Velocity (E-prime) Using Tissue Doppler [Assessed from echo obtained at time of enrollment]

   E-prime is a conventional commonly-used parameter of diastolic function. Higher values of E-prime typically reflect better diastolic function.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Patients scheduled to undergo a clinically indicated left heart cardiac catheterization will be recruited for the study.

Exclusion Criteria:

• Suspected acute ST elevation myocardial infarction.

• Acute coronary syndrome with active ongoing chest pain

• Known or suspected acute aortic dissection

• Known or suspected cardiac tamponade

• Known history of unoperated constrictive pericarditis

• Known or suspected severe aortic stenosis or severe mitral regurgitation

• Heart rhythm other than sinus rhythm on pre-cath EKG

• Age < 18 years old

• Unable to provide informed consent

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Michigan Cardiovascular Center	Ann Arbor	Michigan	United States	48109-5853

Sponsors and Collaborators

• University of Michigan
• Pixel Velocity, Inc. / Epsilon Imaging
• National Heart, Lung, and Blood Institute (NHLBI)

Investigators

• Principal Investigator: Theodore J Kolias, M.D., University of Michigan

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Theodore J. Kolias, Associate Professor, University of Michigan
• ClinicalTrials.gov Identifier: NCT01182805
• Other Study ID Numbers: RF-SPEED; 5R44HL071379
• First Posted: Aug 17, 2010
• Last Update Posted: Aug 3, 2012
• Last Verified: Aug 1, 2012

• Additional relevant MeSH terms: Heart Failure, Diastolic

Study Results

Participant Flow

Arm/Group Title	All Study Participants
Arm/Group Description	All study participants underwent measurement of Diastolic Circumferential Strain Rate during Isovolumic Relaxation as well as measurement of E-prime by tissue Doppler. They also all had evaluation of their diastolic function by the combination of their mitral inflow pattern and invasive measure of left ventricular end-diastolic pressure.
Period Title: Overall Study
STARTED	50
COMPLETED	50
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	Single Arm Study.
Arm/Group Description
Overall Participants	50
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	59 (10)
Sex: Female, Male (Count of Participants)
Female	26 52%
Male	24 48%
Region of Enrollment (participants) [Number]
United States	50 100%

Outcome Measures

1. Primary Outcome

Title	Diastolic Circumferential Strain Rate During Isovolumic Relaxation
Description	Diastolic circumferential strain rate during isovolumic relaxation is a novel measure of diastolic function that measures the rate of relaxation of the left ventricle during the interval of isovolumic relaxation (the period of active relaxation). We would expect that a higher value reflects better relaxation, and better diastolic function.
Time Frame	Assessed from echo obtained at time of enrollment

Outcome Measure Data

Analysis Population Description

Only 26 subjects had adequate images for assessment of DCSR-IVR and had gold standard assessment of diastolic function, and the analysis was limited to these subjects.

Arm/Group Title	Normal Diastolic Function	Grade 1 Diastolic Dysfunction	Grade 2 Diastolic Dysfunction
Arm/Group Description	These were the subjects deemed to have normal diastolic function using the gold standard assessment of mitral inflow and LV end-diastolic pressure (E/A 1 - 2 and LVEDP <= 15 mm Hg).	These were the subjects deemed to have Grade 1 diastolic dysfunction using the gold standard assessment of mitral inflow and LV end-diastolic pressure (E/A < 1.0).	These were the subjects deemed to have Grade 2 diastolic dysfunction using the gold standard assessment of mitral inflow and LV end-diastolic pressure (E/A 1 - 2 and LVEDP > 15 mm Hg).
Measure Participants	7	12	7
Mean (Standard Deviation) [1/sec]	0.61 (0.21)	0.37 (0.19)	0.34 (0.12)

2. Primary Outcome

Title	Early Diastolic Mitral Annular Velocity (E-prime) Using Tissue Doppler
Description	E-prime is a conventional commonly-used parameter of diastolic function. Higher values of E-prime typically reflect better diastolic function.
Time Frame	Assessed from echo obtained at time of enrollment

Outcome Measure Data

Analysis Population Description

Only 25 subjects had adequate images for assessment of DCSR-IVR and interpretable tissue Doppler and gold standard assessment of diastolic function, and the analysis was limited to these subjects.

Arm/Group Title	Normal Diastolic Function	Grade 1 Diastolic Dysfunction	Grade 2 Diastolic Dysfunction
Arm/Group Description	These were the subjects deemed to have normal diastolic function using the gold standard assessment of mitral inflow and LV end-diastolic pressure (E/A 1 - 2 and LVEDP <= 15 mm Hg).	These were the subjects deemed to have Grade 1 diastolic dysfunction using the gold standard assessment of mitral inflow and LV end-diastolic pressure (E/A < 1.0).	These were the subjects deemed to have Grade 2 diastolic dysfunction using the gold standard assessment of mitral inflow and LV end-diastolic pressure (E/A 1 - 2 and LVEDP > 15 mm Hg).
Measure Participants	7	11	7
Mean (Standard Deviation) [cm/sec]	8.1 (1.9)	5.6 (1.7)	7.0 (1.8)

Adverse Events

Arm/Group Title	Single Arm Study.
Arm/Group Description
All Cause Mortality
	Single Arm Study.
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Single Arm Study.
	Affected / at Risk (%)	# Events
Total	0/50 (0%)
Other (Not Including Serious) Adverse Events
	Single Arm Study.
	Affected / at Risk (%)	# Events
Total	0/50 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.