Clinical trial NCT00624884: Velocity Vector Imaging in Patients With Moderate-to-Severe Aortic Regurgitation
Official title: Velocity Vector Imaging in Patients With Moderate-to-Severe Aortic Regurgitation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Aortic Regurgitation
Keywords: Aortic regurgitation,velocity vector imaging
Lead sponsor: Florence Nightingale Hospital, Istanbul
Sponsor class: OTHER
First posted: 2008-02-28
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Tertiary care clinic

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.

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 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

Primary outcomes:
measure: Velocity Vector Imaging derived segmental systolic peak Strain and Strain rates
timeFrame: April 2008
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: TC.Istanbul Bilim University, Florence Nightingale Hospital, Division of Cardiology
state: Sisli
Study officials:
affiliation: T.C. Istanbul Bilim University, Florence Nightingale Hospital, Division of Cardiology
name: Saide Aytekin, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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. doi: 10.1111/j.1540-8175.2007.00438.x.