Radiofrequency-based Speckle Tracking Echocardiography to Evaluate Diastolic Function

NCT ID: NCT01182805

Last Updated: 2023-10-16

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-08-31

Study Completion Date

2010-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Heart Failure, Diastolic

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Single arm study.

Group Type OTHER

Echocardiography system Ultra DCI Model 5000

Intervention Type DEVICE

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.

Echocardiography machine GE Vivid E9

Intervention Type DEVICE

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.

Diastolic function assessment

Intervention Type DEVICE

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.

Interventions

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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.

Intervention Type 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.

Intervention Type 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.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pixel Velocity, Inc. / Epsilon Imaging

INDUSTRY

Sponsor Role collaborator

National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role collaborator

University of Michigan

OTHER

Sponsor Role lead

Responsible Party

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Theodore J. Kolias

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Theodore J Kolias, M.D.

Role: PRINCIPAL_INVESTIGATOR

University of Michigan

Locations

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University of Michigan Cardiovascular Center

Ann Arbor, Michigan, United States

Site Status

Countries

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United States

Other Identifiers

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5R44HL071379

Identifier Type: NIH

Identifier Source: secondary_id

View Link

RF-SPEED

Identifier Type: -

Identifier Source: org_study_id

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