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

Sponsor
Florence Nightingale Hospital, Istanbul (Other)
Overall Status
Completed
CT.gov ID
NCT00624884
Collaborator
(none)
50
1
2
24.9

Study Details

Study Description

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 Intervention/Treatment Phase

    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.

    Study Design

    Study Type:
    Observational
    Anticipated 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 :
    Mar 1, 2008
    Actual Primary Completion Date :
    Apr 1, 2008
    Actual Study Completion Date :
    May 1, 2008

    Arms and Interventions

    Arm Intervention/Treatment
    A

    Patients with moderate-to-severe aortic regurgitation having normal left ventricular ejection fraction

    B

    Age, sex and bodymass index matched healthy subjects

    Outcome Measures

    Primary Outcome Measures

    1. Velocity Vector Imaging derived segmental systolic peak Strain and Strain rates [April 2008]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 75 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Locations

    Site City State Country Postal Code
    1 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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00624884
    Other Study ID Numbers:
    • YT1977
    First Posted:
    Feb 28, 2008
    Last Update Posted:
    Jun 30, 2008
    Last Verified:
    Jun 1, 2008
    Keywords provided by , ,
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jun 30, 2008