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Completed

NCT Number: NCT01182805

Radiofrequency-based Speckle Tracking Echocardiography to Evaluate Diastolic Function

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.

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Key information

Conditions

Heart Failure, Diastolic Cardiovascular Diseases Heart Diseases Heart Failure

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

University of Michigan Cardiovascular Center

Ann Arbor, Michigan, 48109-5853, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Echocardiography system Ultra DCI Model 5000

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

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

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.

Primary outcomes

  1. Diastolic Circumferential Strain Rate During Isovolumic Relaxation

    Time frame: 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

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Collaborators

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

Registry information

Acronym: RF-SPEED

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
Aug 17, 2010
Registry last updated
Oct 16, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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