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
  Purpose

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
Aortic Regurgitation

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Velocity Vector Imaging in Patients With Moderate-to-Severe Aortic Regurgitation

Further study details as provided by Florence Nightingale Hospital, Istanbul:

Primary Outcome Measures:
  • Velocity Vector Imaging derived segmental systolic peak Strain and Strain rates [ Time Frame: April 2008 ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: March 2008
Study Completion Date: May 2008
Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)
Groups/Cohorts
A
Patients with moderate-to-severe aortic regurgitation having normal left ventricular ejection fraction
B
Age, sex and bodymass index matched healthy subjects

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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

Tertiary care clinic

Criteria

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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00624884

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

Publications:
Responsible Party: Prof.Dr.Saide Aytekin, T.C. Istanbul Bilim University, Florence Nightingale Hospital
ClinicalTrials.gov Identifier: NCT00624884     History of Changes
Other Study ID Numbers: YT1977
Study First Received: February 19, 2008
Last Updated: June 27, 2008
Health Authority: Turkey: Ministry of Health; Turkey: Ethics Committee

Keywords provided by Florence Nightingale Hospital, Istanbul:
Aortic regurgitation,velocity vector imaging

Additional relevant MeSH terms:
Aortic Valve Insufficiency
Cardiovascular Diseases
Heart Diseases
Heart Valve Diseases

ClinicalTrials.gov processed this record on October 23, 2014