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

This study has been completed.
Sponsor:
Information provided by:
Florence Nightingale Hospital, Istanbul
ClinicalTrials.gov Identifier:
NCT00624884
First received: February 19, 2008
Last updated: June 27, 2008
Last verified: June 2008

February 19, 2008
June 27, 2008
March 2008
April 2008   (final data collection date for primary outcome measure)
Velocity Vector Imaging derived segmental systolic peak Strain and Strain rates [ Time Frame: April 2008 ] [ Designated as safety issue: No ]
· Velocity Vector Imaging derived segmental systolic peak Strain and Strain rates · Tissue Doppler derived peak systolic velocity:Sa, peak systolic velocity during isovolumic contraction: IVV, isovolumic myocardial acceleration :IVA [ Time Frame: April 2008 ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00624884 on ClinicalTrials.gov Archive Site
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Velocity Vector Imaging in Patients With Moderate-to-Severe Aortic Regurgitation
Velocity Vector Imaging in Patients With Moderate-to-Severe Aortic Regurgitation

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.

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.

Observational
Observational Model: Case Control
Time Perspective: Prospective
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Probability Sample

Tertiary care clinic

Aortic Regurgitation
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  • A
    Patients with moderate-to-severe aortic regurgitation having normal left ventricular ejection fraction
  • B
    Age, sex and bodymass index matched healthy subjects
Sokmen G, Sokmen A, Duzenli A, Soylu A, Ozdemir K. Assessment of myocardial velocities and global function of the left ventricle in asymptomatic patients with moderate-to-severe chronic aortic regurgitation: a tissue Doppler echocardiographic study. Echocardiography. 2007 Jul;24(6):609-14.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
50
May 2008
April 2008   (final data collection date for primary outcome measure)

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
Both
18 Years to 75 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Turkey
 
NCT00624884
YT1977
Yes
Prof.Dr.Saide Aytekin, T.C. Istanbul Bilim University, Florence Nightingale Hospital
Florence Nightingale Hospital, Istanbul
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Principal Investigator: Saide Aytekin, Professor T.C. Istanbul Bilim University, Florence Nightingale Hospital, Division of Cardiology
Florence Nightingale Hospital, Istanbul
June 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP