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Velocity Vector Imaging in Patients With Moderate-to-Severe Aortic Regurgitation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00624884
Recruitment Status : Completed
First Posted : February 28, 2008
Last Update Posted : June 30, 2008
Information provided by:
Florence Nightingale Hospital, Istanbul

Brief Summary:
Velocity Vector Imaging may provide reliable and detailed information on left ventricular segmental function in asymptomatic patients with moderate-to severe AR. This may help to identify subclinical myocardial dysfunction in order to operate early enough to prevent postoperative heart failure and restrict unnecessary early operation which could be associated with operative risks and mortality related to prosthetic valves.

Condition or disease
Aortic Regurgitation

Detailed Description:
Chronic aortic regurgitation (AR) is a progressive process which causes both left ventricular volume and pressure overload. While the volume overload is associated with the degree of the aortic regurgitant volume, the pressure overload occurs as a result of systemic hypertension developed due to increased stroke volume. In early stages, excentric hypertrophy occurs aiming to compensate the volume overload in the left ventricle. Therefore , ejection fraction remains in normal range despite the increasing volume overload. Left ventricular dilatation and impairment in ejection fraction only occur in the end stages of the disease. Asymptomatic patients with chronic aortic regurgitation (AR) have a good prognosis in the presence of preserved systolic function. Therefore it is a challenge to identify patients with subclinical left ventricular (LV) dysfunction. Velocity vector imaging (VVI) is a new echocardiographic method based on two dimensional gray scale imaging, which is angle independent and can provide more accurate data about cardiac function.

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Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: Velocity Vector Imaging in Patients With Moderate-to-Severe Aortic Regurgitation
Study Start Date : March 2008
Actual Primary Completion Date : April 2008
Actual Study Completion Date : May 2008

Resource links provided by the National Library of Medicine

Patients with moderate-to-severe aortic regurgitation having normal left ventricular ejection fraction
Age, sex and bodymass index matched healthy subjects

Primary Outcome Measures :
  1. Velocity Vector Imaging derived segmental systolic peak Strain and Strain rates [ Time Frame: April 2008 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Tertiary care clinic

Inclusion Criteria:

  • Moderate-to-severe aortic regurgitation identified by Standard echocardiography.
  • Chronic isolated aortic regurgitation
  • Being asymptomatic ( Class 1 according to NYHA)
  • Sinusal rhythm

Exclusion Criteria:

  • Ejection fraction < 50%
  • Mitral valve disease accompanied to aortic regurgitation (patients with over mild degree of mitral regurgitation and stenosis
  • Aortic stenosis
  • Previous myocardial infarction, or the patients with >50% coronary occlusion in any of the coronary arteries.
  • Cardiomyopathies
  • AV conduction disorders
  • Chronic renal or hepatic insufficiency
  • Malignities

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00624884

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TC.Istanbul Bilim University, Florence Nightingale Hospital, Division of Cardiology
Istanbul, Sisli, Turkey, 34381
Sponsors and Collaborators
Florence Nightingale Hospital, Istanbul
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Principal Investigator: Saide Aytekin, Professor T.C. Istanbul Bilim University, Florence Nightingale Hospital, Division of Cardiology

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Responsible Party: Prof.Dr.Saide Aytekin, T.C. Istanbul Bilim University, Florence Nightingale Hospital Identifier: NCT00624884    
Other Study ID Numbers: YT1977
First Posted: February 28, 2008    Key Record Dates
Last Update Posted: June 30, 2008
Last Verified: June 2008
Keywords provided by Florence Nightingale Hospital, Istanbul:
Aortic regurgitation,velocity vector imaging
Additional relevant MeSH terms:
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Aortic Valve Insufficiency
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases